Centre for Human Drug Research - CHDR.nl http://www.chdr.nl Het laatste nieuws van CHDR Copyright 2012CHDR 2012-01-31T15:55:29+02:00 Bio-Europe Spring, 19-21 March 2012, Amsterdam http://www.chdr.nl/default.asp?id=778&nieuwsid=148 Bio-Europe Spring Amsterdam, The Netherlands: March 19-21, 2012 
The annual international partnering conference, the Bio-Europe Spring will take place in Amsterdam. CHDR will be present at the event with a stand where our senior consultants will be available for discussions and meetings. In addition, CHDR’s partner organization in the US, CATO Research will join us and together we will be available to present our package of complimentary services. Feel free to visit us at the conference and meet with our consultants in drug development.
Further information on the BIO meeting

Following the BIO-Europe, on Thursday 22 March, the Medical Delta & Leiden Bio Science Park the offer the opportunity to get acquainted with the unique life sciences community in Leiden and arrange a visit to the park. The visit will include presentations, field visits to research sites or companies as well as ample networking opportunities. All side visits include transportation from Amsterdam to the side event location and back.
Read more

]]> Bio-Europe Spring Amsterdam, The Netherlands: March 19-21, 2012 
The annual international partnering conference, the Bio-Europe Spring will take place in Amsterdam. CHDR will be present at the event with a stand where our senior consultants will be available for discussions and meetings. In addition, CHDR’s partner organization in the US, CATO Research will join us and together we will be available to present our package of complimentary services. Feel free to visit us at the conference and meet with our consultants in drug development.
Further information on the BIO meeting

Following the BIO-Europe, on Thursday 22 March, the Medical Delta & Leiden Bio Science Park the offer the opportunity to get acquainted with the unique life sciences community in Leiden and arrange a visit to the park. The visit will include presentations, field visits to research sites or companies as well as ample networking opportunities. All side visits include transportation from Amsterdam to the side event location and back.
Read more

]]> 2012-01-30T15:55:29+02:00 Bibliometric research performance profile http://www.chdr.nl/default.asp?id=778&nieuwsid=149 Bibliometric research performance profile

Using scientific publication and citation data, a bibliometric research performance analysis has been performed to measure the scientific impact and visibility of CHDR.
The number of scientific publications, P, over the last decade (2001 -2010) shows that CHDR has a substantial scientific oeuvre with an increasing volume since 2004 with a performance above world average.

The overall field normalized impact indication (MNCS, mean normalized citation score) - being the most suitable indicator for the international position of an oeuvre - demonstrates a substantial growth of the scientific impact which has grown to well above the world average of 1.




Contact us:
Marieke van den Bosch
Business Development Manager
+31 - 71 - 5246 487
bd@chdr.nl
www.chdr.nl



]]> Bibliometric research performance profile

Using scientific publication and citation data, a bibliometric research performance analysis has been performed to measure the scientific impact and visibility of CHDR.
The number of scientific publications, P, over the last decade (2001 -2010) shows that CHDR has a substantial scientific oeuvre with an increasing volume since 2004 with a performance above world average.

The overall field normalized impact indication (MNCS, mean normalized citation score) - being the most suitable indicator for the international position of an oeuvre - demonstrates a substantial growth of the scientific impact which has grown to well above the world average of 1.




Contact us:
Marieke van den Bosch
Business Development Manager
+31 - 71 - 5246 487
bd@chdr.nl
www.chdr.nl



]]> 2012-01-30T15:55:29+02:00 CHDR Newsletter January 2012 http://www.chdr.nl/default.asp?id=778&nieuwsid=150

CHDR Newsletter January 2012

 


TNO and CHDR join forces in the area of food related clinical trials
TNO and CHDR will bring together their experience and expertise in clinical research and form a new partnership for food related clinical trials. This unique partnership builds on the partners’ highly complementary strengths and is focused on better serving the food industry in its food innovation activities.
The combined strengths of CHDR, with 25 years of high quality early drug development experience, and TNO, with decades of experience in design, performance and reporting of clinical studies with food (ingredients) ensure high quality, in-time and cost effective performance of a broad array of clinical trials. This alliance provides access to virtually every technique and methodology needed in this field.
More information

CHDR donation to 3FM Serious Request
Last year in December, CHDR has donated EUR5000 to 3FM Serious Request which is a yearly project by Dutch radio station 3FM.  Three   DJ’s confine themselves without food to a temporary, transparent radio studio for seven days to collect money for projects of The Red Cross. The proceeds are meant to help mothers in war/conflict zones around the world with essential, basic things like shelter, medical assistance and first aid supplies such as food, water, soap and kitchen utensils. Moreover The Red Cross helps mothers to create their own income and to search for relatives.
More information on Serious Request

Bio-Europe Spring Amsterdam, The Netherlands: March 19-21, 2012 
The annual international partnering conference, the Bio-Europe Spring will take place in Amsterdam. CHDR will be present at the event with a stand where our senior consultants will be available for discussions and meetings. In addition, CHDR’s partner organization in the US, CATO Research will join us and together we will be available to present our package of complimentary services. Feel free to visit us at the conference and meet with our consultants in drug development.
Further information on the BIO meeting

Following the BIO-Europe, on Thursday 22 March, the Medical Delta & Leiden Bio Science Park the offer the opportunity to get acquainted with the unique life sciences community in Leiden and arrange a visit to the park. The visit will include presentations, field visits to research sites or companies as well as ample networking opportunities. All side visits include transportation from Amsterdam to the side event location and back.
Read more

 Trials & Techniques

Anti-coagulant interaction study
To investigate the potential interaction on coagulation between an approved muscle relaxant, which is used in the clinic post-surgically, and anticoagulants enoxaparin or unfractionated heparin, the standard parameters APTT, PT and anti-Xa are investigated in a trial with young healthy males. In addition, APTT will be assessed on ex vivo spiked blood samples with muscle relaxant and/or anticoagulant in various concentrations to facilitate a robust PK-PD model. Based on this model the anticoagulant activity in case of alternative, not clinically evaluated, dosing scenarios of anticoagulant and muscle relaxant may be simulated.
Annelieke Kruithof

Pro-cholinergic drug in a scopolamine model in healthy elderly volunteers
A proof-of-pharmacology study has started with a new pro-cholinergic drug, that will be tested in combination with an already registered cholinesterase inhibitor. It is hypothesized that the combination of these drugs reduces the symptoms of Alzheimer's Disease better than either compound alone. Different dose combinations will be tested in healthy elderly volunteers who will be co-administered with scopolamine to induce temporary symptoms of memory loss and attention deficit. With this study we expect to be able to select an optimal study design for a phase II/III study in patients with Alzheimer's Disease.
Anne Catrien Baakman

UVB Pain model
The range of tests available for testing analgesics is expanding. Validation of an UVB-induced, inflammatory pain test and paradigm for measure evoked potentials is currently underway. In collaboration with the NeuroSIPE group, methodology for measuring small nerve fibre dysfunction, which can result in neuropathic pain, is also being developed. This will add to the already used pain tests including thermal pain, cold pressor, electrical and mechanical pain as well as and a paradigm for measuring DNIC.
Justin Hay

Biosimilars
The development of biosimilars is rapidly increasing and CHDR has invested to provide services for this demanding field of research. Recently, a biosimilar used for oncological indications was tested for the first time in humans. This demanding project, which included state-of-art methodology and imaging was done in >100 volunteers and consisted of a dose-escalation part and a full bioequivalence study. The clinical phase was completed in less than 3 months and analysis is under way.
Joannes Reijers

Posters, Presentations & Publications

PhD-Defence Anthracycline-induced cardiotoxicity
At the 17th of January Freerk Broeyer successfully defended his PhD thesis "Anthracycline-induced cardiotoxicity, a pathophysiology based approach for early detection and protective strategies". In this thesis he explored his research on possible biomarkers for anthracyclin-induced cardiotoxicity and the use of a potentially protective agent in healthy volunteers and patients with breast carcinoma.
More information


Bibliometric research performance profile
Using scientific publication and citation data, a bibliometric research performance analysis has been performed to measure the scientific impact and visibility of CHDR.
The number of scientific publications, P, over the last decade (2001 -2010) shows that CHDR has a substantial scientific oeuvre with an increasing volume since 2004 with a performance above world average.
This increased output was accompanied by a similar increase in quality. The overall field normalized impact indication (MNCS, mean normalized citation score) - being the most suitable indicator for the international position of an oeuvre - demonstrates a substantial growth of the scientific impact which has grown to well above the world average of 1.
Ingrid de Visser




 

Modulation of vasoactivity and platelet aggregation by selective 5-HT receptor antagonism in humans.
J Cardiovasc Pharmacol. 2011; 58 :575-80.
Moerland M, Kemme M, Dijkmans A, Bergougnan L, Burggraaf J.
The vasoactive and antiplatelet effects of the combined 5-HT1B and 5-HT2A receptor blocker SL65.0472-00 were investigated in humans to elucidate the functional involvement of these receptors. SL65.0472-00 has potent antagonistic effect on 5-HT-induced vasoconstriction and platelet aggregation but not on sumatriptan-induced vasoconstriction. This suggests that in humans, SL65.0472-00 is a 5-HT2A blocker without clear 5-HT1B antagonistic activity.

  

Contact us:
Marieke van den Bosch
Business Development Manager
+31 - 71 - 5246 487
bd@chdr.nl
www.chdr.nl

Subscribe to newsletter

]]>

CHDR Newsletter January 2012

 


TNO and CHDR join forces in the area of food related clinical trials
TNO and CHDR will bring together their experience and expertise in clinical research and form a new partnership for food related clinical trials. This unique partnership builds on the partners’ highly complementary strengths and is focused on better serving the food industry in its food innovation activities.
The combined strengths of CHDR, with 25 years of high quality early drug development experience, and TNO, with decades of experience in design, performance and reporting of clinical studies with food (ingredients) ensure high quality, in-time and cost effective performance of a broad array of clinical trials. This alliance provides access to virtually every technique and methodology needed in this field.
More information

CHDR donation to 3FM Serious Request
Last year in December, CHDR has donated EUR5000 to 3FM Serious Request which is a yearly project by Dutch radio station 3FM.  Three   DJ’s confine themselves without food to a temporary, transparent radio studio for seven days to collect money for projects of The Red Cross. The proceeds are meant to help mothers in war/conflict zones around the world with essential, basic things like shelter, medical assistance and first aid supplies such as food, water, soap and kitchen utensils. Moreover The Red Cross helps mothers to create their own income and to search for relatives.
More information on Serious Request

Bio-Europe Spring Amsterdam, The Netherlands: March 19-21, 2012 
The annual international partnering conference, the Bio-Europe Spring will take place in Amsterdam. CHDR will be present at the event with a stand where our senior consultants will be available for discussions and meetings. In addition, CHDR’s partner organization in the US, CATO Research will join us and together we will be available to present our package of complimentary services. Feel free to visit us at the conference and meet with our consultants in drug development.
Further information on the BIO meeting

Following the BIO-Europe, on Thursday 22 March, the Medical Delta & Leiden Bio Science Park the offer the opportunity to get acquainted with the unique life sciences community in Leiden and arrange a visit to the park. The visit will include presentations, field visits to research sites or companies as well as ample networking opportunities. All side visits include transportation from Amsterdam to the side event location and back.
Read more

 Trials & Techniques

Anti-coagulant interaction study
To investigate the potential interaction on coagulation between an approved muscle relaxant, which is used in the clinic post-surgically, and anticoagulants enoxaparin or unfractionated heparin, the standard parameters APTT, PT and anti-Xa are investigated in a trial with young healthy males. In addition, APTT will be assessed on ex vivo spiked blood samples with muscle relaxant and/or anticoagulant in various concentrations to facilitate a robust PK-PD model. Based on this model the anticoagulant activity in case of alternative, not clinically evaluated, dosing scenarios of anticoagulant and muscle relaxant may be simulated.
Annelieke Kruithof

Pro-cholinergic drug in a scopolamine model in healthy elderly volunteers
A proof-of-pharmacology study has started with a new pro-cholinergic drug, that will be tested in combination with an already registered cholinesterase inhibitor. It is hypothesized that the combination of these drugs reduces the symptoms of Alzheimer's Disease better than either compound alone. Different dose combinations will be tested in healthy elderly volunteers who will be co-administered with scopolamine to induce temporary symptoms of memory loss and attention deficit. With this study we expect to be able to select an optimal study design for a phase II/III study in patients with Alzheimer's Disease.
Anne Catrien Baakman

UVB Pain model
The range of tests available for testing analgesics is expanding. Validation of an UVB-induced, inflammatory pain test and paradigm for measure evoked potentials is currently underway. In collaboration with the NeuroSIPE group, methodology for measuring small nerve fibre dysfunction, which can result in neuropathic pain, is also being developed. This will add to the already used pain tests including thermal pain, cold pressor, electrical and mechanical pain as well as and a paradigm for measuring DNIC.
Justin Hay

Biosimilars
The development of biosimilars is rapidly increasing and CHDR has invested to provide services for this demanding field of research. Recently, a biosimilar used for oncological indications was tested for the first time in humans. This demanding project, which included state-of-art methodology and imaging was done in >100 volunteers and consisted of a dose-escalation part and a full bioequivalence study. The clinical phase was completed in less than 3 months and analysis is under way.
Joannes Reijers

Posters, Presentations & Publications

PhD-Defence Anthracycline-induced cardiotoxicity
At the 17th of January Freerk Broeyer successfully defended his PhD thesis "Anthracycline-induced cardiotoxicity, a pathophysiology based approach for early detection and protective strategies". In this thesis he explored his research on possible biomarkers for anthracyclin-induced cardiotoxicity and the use of a potentially protective agent in healthy volunteers and patients with breast carcinoma.
More information


Bibliometric research performance profile
Using scientific publication and citation data, a bibliometric research performance analysis has been performed to measure the scientific impact and visibility of CHDR.
The number of scientific publications, P, over the last decade (2001 -2010) shows that CHDR has a substantial scientific oeuvre with an increasing volume since 2004 with a performance above world average.
This increased output was accompanied by a similar increase in quality. The overall field normalized impact indication (MNCS, mean normalized citation score) - being the most suitable indicator for the international position of an oeuvre - demonstrates a substantial growth of the scientific impact which has grown to well above the world average of 1.
Ingrid de Visser




 

Modulation of vasoactivity and platelet aggregation by selective 5-HT receptor antagonism in humans.
J Cardiovasc Pharmacol. 2011; 58 :575-80.
Moerland M, Kemme M, Dijkmans A, Bergougnan L, Burggraaf J.
The vasoactive and antiplatelet effects of the combined 5-HT1B and 5-HT2A receptor blocker SL65.0472-00 were investigated in humans to elucidate the functional involvement of these receptors. SL65.0472-00 has potent antagonistic effect on 5-HT-induced vasoconstriction and platelet aggregation but not on sumatriptan-induced vasoconstriction. This suggests that in humans, SL65.0472-00 is a 5-HT2A blocker without clear 5-HT1B antagonistic activity.

  

Contact us:
Marieke van den Bosch
Business Development Manager
+31 - 71 - 5246 487
bd@chdr.nl
www.chdr.nl

Subscribe to newsletter

]]> 2012-01-30T15:55:29+02:00 TNO and CHDR join forces in the area of food related clinical trials http://www.chdr.nl/default.asp?id=778&nieuwsid=147

TNO and CHDR join forces in the area of food related clinical trials
24 January 2012

TNO and CHDR will bring together their experience and expertise in clinical research and form a new partnership for food related clinical trials. This unique partnership builds on the partners’ highly complementary strengths and is focused on better serving the food industry in its food innovation activities.

In the current market for food development, the combined experience, expertise and assets from food research and pharma related clinical trials leads to a new proposition to the food industry that includes above-standard quality and cost efficiency and an innovative approach to research projects, which will help our customers to drive their development programs forward with increased focus and speed.

The combined strengths of CHDR, with 25 years of high quality early drug development experience, and TNO, with decades of experience in design, performance and reporting of clinical studies with food (ingredients) ensure high quality, in-time and cost effective performance of a broad array of clinical trials. This alliance provides access to virtually every technique and methodology needed in this field.

Further important assets of the alliance comprise:

  • Unique human capital, highly experienced staff with expertise in numerous indications
  • Experience in both food and pharma clinical trials
  • Wide range of validated biomarkers
  • Possibility to use microdosing and microtracers
  • Leading combination of academic expertise and operational experience
  • A large database of volunteers in several age ranges
  • Compliance with ICH GCP embedded in a QA system
  • 21 CFR part 11 compliant data management system.

 

About TNO

TNO is an independent innovation organisation. TNO connects people and knowledge to create innovations that sustainably boost the competitive strength of industry and the welfare of society. TNO’s more than 3500 professionals work on practicable knowledge and solutions for the problems of global scarcity. TNO focuses its efforts on seven themes: Healthy Living, Industrial Innovation, Energy/Geological Survey of the Netherlands, Transport and Mobility, Built Environment, Information Society, and Safety, Defence and Security.

Over the years, TNO has built a track record in clinical trials, working with all major food manufacturers, both in food innovation, preclinical and clinical studies. Furthermore, TNO is solidly anchored in innovative health-research consortia, enabling customers to tap into the newest insights.

More information:

CHDR
Prof. dr. Adam Cohen
CEO
E bd@chdr.nl
T +31 71 5246 400


TNO
Dr. Jeroen Groot
Research Manager
T +31 88 866 2399

]]>

TNO and CHDR join forces in the area of food related clinical trials
24 January 2012

TNO and CHDR will bring together their experience and expertise in clinical research and form a new partnership for food related clinical trials. This unique partnership builds on the partners’ highly complementary strengths and is focused on better serving the food industry in its food innovation activities.

In the current market for food development, the combined experience, expertise and assets from food research and pharma related clinical trials leads to a new proposition to the food industry that includes above-standard quality and cost efficiency and an innovative approach to research projects, which will help our customers to drive their development programs forward with increased focus and speed.

The combined strengths of CHDR, with 25 years of high quality early drug development experience, and TNO, with decades of experience in design, performance and reporting of clinical studies with food (ingredients) ensure high quality, in-time and cost effective performance of a broad array of clinical trials. This alliance provides access to virtually every technique and methodology needed in this field.

Further important assets of the alliance comprise:

  • Unique human capital, highly experienced staff with expertise in numerous indications
  • Experience in both food and pharma clinical trials
  • Wide range of validated biomarkers
  • Possibility to use microdosing and microtracers
  • Leading combination of academic expertise and operational experience
  • A large database of volunteers in several age ranges
  • Compliance with ICH GCP embedded in a QA system
  • 21 CFR part 11 compliant data management system.

 

About TNO

TNO is an independent innovation organisation. TNO connects people and knowledge to create innovations that sustainably boost the competitive strength of industry and the welfare of society. TNO’s more than 3500 professionals work on practicable knowledge and solutions for the problems of global scarcity. TNO focuses its efforts on seven themes: Healthy Living, Industrial Innovation, Energy/Geological Survey of the Netherlands, Transport and Mobility, Built Environment, Information Society, and Safety, Defence and Security.

Over the years, TNO has built a track record in clinical trials, working with all major food manufacturers, both in food innovation, preclinical and clinical studies. Furthermore, TNO is solidly anchored in innovative health-research consortia, enabling customers to tap into the newest insights.

More information:

CHDR
Prof. dr. Adam Cohen
CEO
E bd@chdr.nl
T +31 71 5246 400


TNO
Dr. Jeroen Groot
Research Manager
T +31 88 866 2399

]]> 2012-01-24T15:55:29+02:00 CHDR Newsletter Winter 2011 http://www.chdr.nl/default.asp?id=778&nieuwsid=145

CHDR Newsletter Winter 2011

 

 
 
New Research Director: Pierre Peeters
Since beginning of October Pierre Peeters has joined CHDR as Research Director, responsible for business to business activities with emphasis on clinical trials with food (ingredients). Pierre has more than 25 years experience in pharmaceutical industry, both at a CRO as well as, during the last 13 years in medium/large Pharma (Organon, Merck /MSD) where he was responsible for the study design, conduct and reporting of several hundred early clinical trials and clinical development plans in various indications. Pierre received his degree in Chemistry at the University of Nijmegen and his PhD in Bio Pharmaceutics at Utrecht University. He is a registered Clinical Pharmacologist. 


Introduction course to Population PK and PK/PD modeling with NONMEM
This hands-on course lectured by dr. Jan Freijer on December 7-9 is an introduction to population modeling for analyzing pharmacokinetic and pharmacodynamic data, and is intended for researchers in drug development who wish to expand their knowledge in this field. The course discusses the general concept of population modeling and the application in drug development. The course also includes a series of hands-on examples, which enables the attendees to learn to work with NONMEM and R to solve standard pharmacokinetic and pharmacodynamic problems, including data file preparation, model coding, and visualization/interpretation of the results. Although the course is intended for beginners, some affinity with quantitative methods and basic knowledge on PK/PD concepts will be useful.
Registration is closed; a new course will be given next year.


E-Learning Pharmacology Database TRC hits the two million
In the academic year 2010/2011, there were 1600 unique users that studied 300.000 pages of TRC. Just before exams more than 5000 items were reviewed per day as it had been shown that studying with the TRC leads to higher scores in the exam. And that’s not the all of the good news. Still this year we will register the 2.000.000th hit and to celebrate this (mega) event, the diligent TRC user in question will receive a free copy of the textbook Goodman & Gilman's ‘The Pharmacological Basis of Therapeutics’.
Read More or visit TRC via  http://coo.lumc.nl/TRC.



Trials & Techniques

Biosimilars
Biosimilars are increasingly developed and CHDR has invested to provide services for this demanding field of research. Recently, a biosimilar used for oncological indications was tested for the first time in humans. This demanding project, which included state-of-art methodology and imaging was done in >100 volunteers and consisted of a dose-escalation part and a full bioequivalence study. The clinical phase was completed in less than 3 months and analysis is under way.
Joannes Reijers

New analgesic compound for the treatment of neuropathic pain
A multiple ascending dose study has started with a new analgesic compound for the treatment of neuropathic pain. In this study, 24 patients with sciatica are enrolled and randomized to receive three doses of this new compound or placebo. Safety, tolerability and efficacy will be assessed using CHDR's PainCart to profile the analgesic effects of this compound on multiple pain mechanisms.
Pieter Okkerse


Innovative approach to improve renal function in diabetic patients
A proof-of-pharmacology trial has started in which a novel drug is being tested in diabetic patients. The drug is under development for the treatment of albuminuria as frequently observed in diabetes. Preclinical work and earlier human studies demonstrated that this compound potentially limits renal damage and improves glycemic control by inhibiting the infiltration of proinflammatory monocytes into tissues. This new treatment modality may help in diabetic nephropathy, a condition that is currently not optimally controlled in many patients.
Joannes Reijers


FIH of a new exploratory hypnotic agent
CHDR's Neurocart will be used in a FIH dose escalation study to test the PK, safety, PD and side effect profile of a potential new drug for insomnia. This investigational drug addressing a novel mechanism of action, will be profiled using several NeuroCart pharmacodynamic parameters. Escalation to the next dose level will be determined using tolerability and PD data of the previous dose level. The trial also includes an active reference crossover cohort to assist dose finding and compare side effects for further phase II studies. This informative trial is expected to facilitate shorter development time lines towards phase III.
Helene van Gorsel



Posters, Presentations & Publications

BPS Winter Meeting Symposium
Professor Adam Cohen is invited to present 'The reattachment of pharmacology to clinical pharmacology. Developing drug prototypes by question based drug development and using innovative designs' at the British Pharmacological Society Winter Meeting, London 2011.
Register via this link


A literature review on pharmacological sensitivity of human experimental hyperalgesic pain models.
Human experimental pain models are often used in early phase drug development to identify the efficacy of novel and existing drugs. Hyperalgesia and allodynia can be experimentally induced to mimic symptoms of inflammatory or neuropathic pain by exposure to UV-B, capsaicin or a thermal burn.
Guido van Amerongen


A meta-analysis of pharmacodynamic testing with the NeuroCart used in the early phase drug development of CNS depressant agents.
These results show that by using a range of CNS tests, drugs can be profiled with unique CNS 'fingerprints', reflecting their distinct mechanism of action. This information can be used as a frame of reference to determine the pharmacological activity of new compounds during early development.
Justin Hay


Introduction to haemostasis from a pharmacodynamic perspective.
Kluft C, Burggraaf J.
Br J Clin Pharmacol 2011; 72: 538-546
Biochemical characterization of the haemostatic system has advanced significantly in the past decades. Many examples are available to show that traditional general methods of clotting and lysis do not provide the information that is desired. The conclusion is reached that there is a need for integrated or global methods or sets of methods that reflect the complexity and individual status appropriately and allow the practitioner to judge the effects of interventions and their individual aspects.


The Perception and Pharmacokinetics of a 20-mg Dose of Escitalopram Orodispersible Tablets in a Relative Bioavailability Study in Healthy Men.
Nilausen DØ, Zuiker RG, van Gerven J.
Clin Ther. 2011; 33: 1492-1502.
Rapidly dissolving oral (orodispersible) drug formulations have been developed to overcome problems related to swallowing. The aim of this study was to compare the bioavailability of orodispersible and conventional immediate-release (IR) escitalopram tablets. In this small study population of fasting healthy male volunteers, 2 × 10-mg ODTs or 1 × 20-mg ODT and 2 × 10-mg conventional IR escitalopram tablets met the regulatory criteria for assumed bioequivalence.


Acute effects of MDMA (3,4-methylenedioxymethamphetamine) on EEG oscillations: alone and in combination with ethanol or THC (delta-9-tetrahydrocannabinol).
Lansbergen MM, Dumont GJ, van Gerven JM, Buitelaar JK, Verkes RJ.
Psychopharmacology. 2011; 213: 745-756
The aim of the present study was to investigate whether co-administration of alcohol or THC with MDMA differentially affects ongoing electroencephalogram (EEG) oscillations compared to the administration of each drug alone. The findings indicate that the combined intake of MDMA and THC, but not of MDMA and alcohol, affects ongoing EEG oscillations differently than the sum of either one drug alone. Changes in ongoing EEG oscillations may be related to the impaired task performance that has often been reported after drug intake.


Improving the quality of drug research or simply increasing its cost? An evidence-based study of the cost for data monitoring in clinical trials.
Pronker E, Geerts BF, Cohen A, Pieterse H.
Br J Clin Pharmacol. 2011 ;71:467-70. 
Procedures for verification of data from clinical studies are intended to maintain reliability for clinical trial results. Guidelines or legislations relating to clinical data management are of limited value and no study has yet demonstrated its effectiveness.
Sponsor queries and dual entry procedures from one CRO on three different phase I trials are analysed on content, impact and cost. In this study, sponsor queries and dual entry procedures proved time and cost inefficient in detecting data discrepancies. We advocate a more evidence-based approach for enhancing data integrity throughout the process of clinical data man agement.

Contact us:
Marieke van den Bosch
Business Development Manager
+31 - 71 - 5246 487
bd@chdr.nl
www.chdr.nl

]]>

CHDR Newsletter Winter 2011

 

 
 
New Research Director: Pierre Peeters
Since beginning of October Pierre Peeters has joined CHDR as Research Director, responsible for business to business activities with emphasis on clinical trials with food (ingredients). Pierre has more than 25 years experience in pharmaceutical industry, both at a CRO as well as, during the last 13 years in medium/large Pharma (Organon, Merck /MSD) where he was responsible for the study design, conduct and reporting of several hundred early clinical trials and clinical development plans in various indications. Pierre received his degree in Chemistry at the University of Nijmegen and his PhD in Bio Pharmaceutics at Utrecht University. He is a registered Clinical Pharmacologist. 


Introduction course to Population PK and PK/PD modeling with NONMEM
This hands-on course lectured by dr. Jan Freijer on December 7-9 is an introduction to population modeling for analyzing pharmacokinetic and pharmacodynamic data, and is intended for researchers in drug development who wish to expand their knowledge in this field. The course discusses the general concept of population modeling and the application in drug development. The course also includes a series of hands-on examples, which enables the attendees to learn to work with NONMEM and R to solve standard pharmacokinetic and pharmacodynamic problems, including data file preparation, model coding, and visualization/interpretation of the results. Although the course is intended for beginners, some affinity with quantitative methods and basic knowledge on PK/PD concepts will be useful.
Registration is closed; a new course will be given next year.


E-Learning Pharmacology Database TRC hits the two million
In the academic year 2010/2011, there were 1600 unique users that studied 300.000 pages of TRC. Just before exams more than 5000 items were reviewed per day as it had been shown that studying with the TRC leads to higher scores in the exam. And that’s not the all of the good news. Still this year we will register the 2.000.000th hit and to celebrate this (mega) event, the diligent TRC user in question will receive a free copy of the textbook Goodman & Gilman's ‘The Pharmacological Basis of Therapeutics’.
Read More or visit TRC via  http://coo.lumc.nl/TRC.



Trials & Techniques

Biosimilars
Biosimilars are increasingly developed and CHDR has invested to provide services for this demanding field of research. Recently, a biosimilar used for oncological indications was tested for the first time in humans. This demanding project, which included state-of-art methodology and imaging was done in >100 volunteers and consisted of a dose-escalation part and a full bioequivalence study. The clinical phase was completed in less than 3 months and analysis is under way.
Joannes Reijers

New analgesic compound for the treatment of neuropathic pain
A multiple ascending dose study has started with a new analgesic compound for the treatment of neuropathic pain. In this study, 24 patients with sciatica are enrolled and randomized to receive three doses of this new compound or placebo. Safety, tolerability and efficacy will be assessed using CHDR's PainCart to profile the analgesic effects of this compound on multiple pain mechanisms.
Pieter Okkerse


Innovative approach to improve renal function in diabetic patients
A proof-of-pharmacology trial has started in which a novel drug is being tested in diabetic patients. The drug is under development for the treatment of albuminuria as frequently observed in diabetes. Preclinical work and earlier human studies demonstrated that this compound potentially limits renal damage and improves glycemic control by inhibiting the infiltration of proinflammatory monocytes into tissues. This new treatment modality may help in diabetic nephropathy, a condition that is currently not optimally controlled in many patients.
Joannes Reijers


FIH of a new exploratory hypnotic agent
CHDR's Neurocart will be used in a FIH dose escalation study to test the PK, safety, PD and side effect profile of a potential new drug for insomnia. This investigational drug addressing a novel mechanism of action, will be profiled using several NeuroCart pharmacodynamic parameters. Escalation to the next dose level will be determined using tolerability and PD data of the previous dose level. The trial also includes an active reference crossover cohort to assist dose finding and compare side effects for further phase II studies. This informative trial is expected to facilitate shorter development time lines towards phase III.
Helene van Gorsel



Posters, Presentations & Publications

BPS Winter Meeting Symposium
Professor Adam Cohen is invited to present 'The reattachment of pharmacology to clinical pharmacology. Developing drug prototypes by question based drug development and using innovative designs' at the British Pharmacological Society Winter Meeting, London 2011.
Register via this link


A literature review on pharmacological sensitivity of human experimental hyperalgesic pain models.
Human experimental pain models are often used in early phase drug development to identify the efficacy of novel and existing drugs. Hyperalgesia and allodynia can be experimentally induced to mimic symptoms of inflammatory or neuropathic pain by exposure to UV-B, capsaicin or a thermal burn.
Guido van Amerongen


A meta-analysis of pharmacodynamic testing with the NeuroCart used in the early phase drug development of CNS depressant agents.
These results show that by using a range of CNS tests, drugs can be profiled with unique CNS 'fingerprints', reflecting their distinct mechanism of action. This information can be used as a frame of reference to determine the pharmacological activity of new compounds during early development.
Justin Hay


Introduction to haemostasis from a pharmacodynamic perspective.
Kluft C, Burggraaf J.
Br J Clin Pharmacol 2011; 72: 538-546
Biochemical characterization of the haemostatic system has advanced significantly in the past decades. Many examples are available to show that traditional general methods of clotting and lysis do not provide the information that is desired. The conclusion is reached that there is a need for integrated or global methods or sets of methods that reflect the complexity and individual status appropriately and allow the practitioner to judge the effects of interventions and their individual aspects.


The Perception and Pharmacokinetics of a 20-mg Dose of Escitalopram Orodispersible Tablets in a Relative Bioavailability Study in Healthy Men.
Nilausen DØ, Zuiker RG, van Gerven J.
Clin Ther. 2011; 33: 1492-1502.
Rapidly dissolving oral (orodispersible) drug formulations have been developed to overcome problems related to swallowing. The aim of this study was to compare the bioavailability of orodispersible and conventional immediate-release (IR) escitalopram tablets. In this small study population of fasting healthy male volunteers, 2 × 10-mg ODTs or 1 × 20-mg ODT and 2 × 10-mg conventional IR escitalopram tablets met the regulatory criteria for assumed bioequivalence.


Acute effects of MDMA (3,4-methylenedioxymethamphetamine) on EEG oscillations: alone and in combination with ethanol or THC (delta-9-tetrahydrocannabinol).
Lansbergen MM, Dumont GJ, van Gerven JM, Buitelaar JK, Verkes RJ.
Psychopharmacology. 2011; 213: 745-756
The aim of the present study was to investigate whether co-administration of alcohol or THC with MDMA differentially affects ongoing electroencephalogram (EEG) oscillations compared to the administration of each drug alone. The findings indicate that the combined intake of MDMA and THC, but not of MDMA and alcohol, affects ongoing EEG oscillations differently than the sum of either one drug alone. Changes in ongoing EEG oscillations may be related to the impaired task performance that has often been reported after drug intake.


Improving the quality of drug research or simply increasing its cost? An evidence-based study of the cost for data monitoring in clinical trials.
Pronker E, Geerts BF, Cohen A, Pieterse H.
Br J Clin Pharmacol. 2011 ;71:467-70. 
Procedures for verification of data from clinical studies are intended to maintain reliability for clinical trial results. Guidelines or legislations relating to clinical data management are of limited value and no study has yet demonstrated its effectiveness.
Sponsor queries and dual entry procedures from one CRO on three different phase I trials are analysed on content, impact and cost. In this study, sponsor queries and dual entry procedures proved time and cost inefficient in detecting data discrepancies. We advocate a more evidence-based approach for enhancing data integrity throughout the process of clinical data man agement.

Contact us:
Marieke van den Bosch
Business Development Manager
+31 - 71 - 5246 487
bd@chdr.nl
www.chdr.nl

]]> 2011-12-02T15:55:29+02:00 New Research Director: Pierre Peeters http://www.chdr.nl/default.asp?id=778&nieuwsid=146 New Research Director: Pierre Peeters
 
Since beginning of October Pierre Peeters has joined CHDR as Research Director, responsible for business to business activities with emphasis on clinical trials with food (ingredients). Pierre has more than 25 years experience in pharmaceutical industry, both at a CRO as well as, during the last 13 years in medium/large Pharma (Organon, Merck /MSD) where he was responsible for the study design, conduct and reporting of several hundred early clinical trials and clinical development plans in various indications. Pierre received his degree in Chemistry at the University of Nijmegen and his PhD in Bio Pharmaceutics at Utrecht University. He is a registered Clinical Pharmacologist. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
]]> New Research Director: Pierre Peeters
 
Since beginning of October Pierre Peeters has joined CHDR as Research Director, responsible for business to business activities with emphasis on clinical trials with food (ingredients). Pierre has more than 25 years experience in pharmaceutical industry, both at a CRO as well as, during the last 13 years in medium/large Pharma (Organon, Merck /MSD) where he was responsible for the study design, conduct and reporting of several hundred early clinical trials and clinical development plans in various indications. Pierre received his degree in Chemistry at the University of Nijmegen and his PhD in Bio Pharmaceutics at Utrecht University. He is a registered Clinical Pharmacologist. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
]]> 2011-12-02T15:55:29+02:00 E-Learning Pharmacology Database TRC hits the two million http://www.chdr.nl/default.asp?id=778&nieuwsid=144 Since recently, the Teaching Resource Center features new hyperlinks to the British National Formulary (BNF) giving better access to users from UK and development countries. Improving the utility of the TRC has been realized in a collaborative project in which Manchester University, the BNF and the Leiden TRC team worked closely together. With this improvement also the user group is growing. In the academic year 2010/2011, there were 1600 unique users that studied 300.000 pages of TRC. Just before exams more than 5000 items were reviewed per day as it had been shown that studying with the TRC leads to higher scores in the exam. And that’s not the all of the good news. Still this year we will register the 2.000.000th hit and to celebrate this (mega) event, the diligent TRC user in question will receive a free copy of the textbook Goodman & Gilman's ‘The Pharmacological Basis of Therapeutics’. In future, the TRC will be developed in a mobile pharmacology application with interactive animations, short explanatory movies and an improved assessment tool. This will be achieved in close collaboration with the universities of Manchester, Edinburgh and Heidelberg.

About TRC
The Teaching Resource Center is a pharmacology database that is freely available to all educators and students worldwide under http://coo.lumc.nl/TRC. Based upon the physiology and pathophysiology the pharmacological mechanisms are illustrated schematically with the icon language and are supported by explanatory text. Students can assess their gained knowledge with multiple choice questions including feedback on the answers. The TRC was initially only used by the Dutch community but in the last year has become more popular abroad, for instance students of Manchester University medical school and University of Colorado are frequent users.
Robert Rissmann

 

 

 














Figure: An illustrative example of the TRC’s depiction of pharmacological mechanism.

 

]]> Since recently, the Teaching Resource Center features new hyperlinks to the British National Formulary (BNF) giving better access to users from UK and development countries. Improving the utility of the TRC has been realized in a collaborative project in which Manchester University, the BNF and the Leiden TRC team worked closely together. With this improvement also the user group is growing. In the academic year 2010/2011, there were 1600 unique users that studied 300.000 pages of TRC. Just before exams more than 5000 items were reviewed per day as it had been shown that studying with the TRC leads to higher scores in the exam. And that’s not the all of the good news. Still this year we will register the 2.000.000th hit and to celebrate this (mega) event, the diligent TRC user in question will receive a free copy of the textbook Goodman & Gilman's ‘The Pharmacological Basis of Therapeutics’. In future, the TRC will be developed in a mobile pharmacology application with interactive animations, short explanatory movies and an improved assessment tool. This will be achieved in close collaboration with the universities of Manchester, Edinburgh and Heidelberg.

About TRC
The Teaching Resource Center is a pharmacology database that is freely available to all educators and students worldwide under http://coo.lumc.nl/TRC. Based upon the physiology and pathophysiology the pharmacological mechanisms are illustrated schematically with the icon language and are supported by explanatory text. Students can assess their gained knowledge with multiple choice questions including feedback on the answers. The TRC was initially only used by the Dutch community but in the last year has become more popular abroad, for instance students of Manchester University medical school and University of Colorado are frequent users.
Robert Rissmann

 

 

 














Figure: An illustrative example of the TRC’s depiction of pharmacological mechanism.

 

]]> 2011-11-28T15:55:29+02:00 CHDR Introduction course to Population PK and PK/PD modeling with NONMEM http://www.chdr.nl/default.asp?id=778&nieuwsid=143 P.s. Registration is closed, a new course will be given next year (2012).

 

Abstract
This hands-on course is an introduction to population modeling for analyzing pharmacokinetic and pharmacodynamic data, and is intended for researchers in drug development who wish to expand their knowledge in this field. The course discusses the general concept of population modeling and the application in drug development. The course also includes a series of hands-on examples, which enables the attendees to learn to work with NONMEM and R to solve standard pharmacokinetic and pharmacodynamic problems, including data file preparation, model coding, and visualization/interpretation of the results. Although the course is intended for beginners, some affinity with quantitative methods and basic knowledge on PK/PD concepts will be useful.

Course Objectives
Aim of the course is to familiarize the participants with basics of population PK/PD modeling and to train the participants in working with NONMEM (Non Linear Mixed Effects Modeling) to conduct population PK and PK/PD data analyses.

Details
Lecturer: Dr. Jan Freijer (info@chdr.nl)
Duration: 3 x 8 hours
Dates: December 7-9, 2011; 9:00 – 17:00
Location: CHDR Conference Hall
Language: English
Number participants: 8-10
Target audience: Scientists and students with the aim to apply population PK/PD modeling in their research

Program
Session 1 Agenda and brief introduction to population PK modeling, NONMEM, and R
Session 2 NONMEM work flow for population PK models (data management, data exploration, model code and execution, output and interpretation)
Session 3 Population PK models continued: Different administration routes, solving differential equations using NONMEM, simulation
Session 4 Population PK/PD models: Brief introduction to PK/PD models and implementation of direct effect models in NONMEM
Session 5 Population PK/PD models continued: Effect compartment and indirect response models

Download this document in PDF

]]> P.s. Registration is closed, a new course will be given next year (2012).

 

Abstract
This hands-on course is an introduction to population modeling for analyzing pharmacokinetic and pharmacodynamic data, and is intended for researchers in drug development who wish to expand their knowledge in this field. The course discusses the general concept of population modeling and the application in drug development. The course also includes a series of hands-on examples, which enables the attendees to learn to work with NONMEM and R to solve standard pharmacokinetic and pharmacodynamic problems, including data file preparation, model coding, and visualization/interpretation of the results. Although the course is intended for beginners, some affinity with quantitative methods and basic knowledge on PK/PD concepts will be useful.

Course Objectives
Aim of the course is to familiarize the participants with basics of population PK/PD modeling and to train the participants in working with NONMEM (Non Linear Mixed Effects Modeling) to conduct population PK and PK/PD data analyses.

Details
Lecturer: Dr. Jan Freijer (info@chdr.nl)
Duration: 3 x 8 hours
Dates: December 7-9, 2011; 9:00 – 17:00
Location: CHDR Conference Hall
Language: English
Number participants: 8-10
Target audience: Scientists and students with the aim to apply population PK/PD modeling in their research

Program
Session 1 Agenda and brief introduction to population PK modeling, NONMEM, and R
Session 2 NONMEM work flow for population PK models (data management, data exploration, model code and execution, output and interpretation)
Session 3 Population PK models continued: Different administration routes, solving differential equations using NONMEM, simulation
Session 4 Population PK/PD models: Brief introduction to PK/PD models and implementation of direct effect models in NONMEM
Session 5 Population PK/PD models continued: Effect compartment and indirect response models

Download this document in PDF

]]> 2011-10-10T15:55:29+02:00 BPS Winter Meeting Symposium http://www.chdr.nl/default.asp?id=778&nieuwsid=142 Professor Adam Cohen is invited to present 'The reattachment of pharmacology to clinical pharmacology. Developing drug prototypes by question based drug development and using innovative designs' at the British Pharmacological Society Winter Meeting, London 2011.
 
For more information please contact;
bd@chdr.nl
 
Register via this link
 

]]> Professor Adam Cohen is invited to present 'The reattachment of pharmacology to clinical pharmacology. Developing drug prototypes by question based drug development and using innovative designs' at the British Pharmacological Society Winter Meeting, London 2011.
 
For more information please contact;
bd@chdr.nl
 
Register via this link
 

]]> 2011-10-07T15:55:29+02:00 Newsletter Autumn 2011 http://www.chdr.nl/default.asp?id=778&nieuwsid=141

 

 

 

New CHDR building Update: Breaking of ground ceremony has been a great success

Together, the mayor of Leiden, Henri Lenferink, and the Rector Magnificus of Leiden University, professor Paul van der Heijden, drove the first pile and called it a symbol of the cooperation between CHDR, Leiden University and the community of Leiden. With champagne and live music, 250 employees, family, neighbors and friends celebrated the big event.
With his new building CHDR creates extra capacity to do research and offer volunteers more facilities such as a private room. Adam Cohen: ‘This is a lot more comfortable for the subjects, and it will be much more appealing for new volunteers. They are crucial to our research’.
More Information

 

 

 

 

 

CCMO Annual Report 2010
The Competent Authority of the Netherlands, the CCMO (Central Committee on Research Involving Human Subjects), has published its annual report of 2010. One of the CCMO’s mandates is to oversee accredited
MREC’s (Medical research ethics committees) based on reports, incidents or negative outcomes of clinical scientific research. For the CCMO, the year 2010 was explicitly dedicated to this task.
More Information

Grant to investigate novel functional imaging markers of dementia
Prof. Joop van Gerven, research director of CNS research, has received a ‘Brain Function and Dysfunction over the Lifespan’ grant from Leiden University to investigate novel functional markers of dementia using pharmacological resting state FMRI. Using this technique the brain’s responses will be explored after administration of challenge agents that target specific neurotransmitter systems. RS-FMRI is a promising new technique, which has recently shown drug-induced changes in CNS network activities, which were closely associated with the pharmacological actions of different classes of compounds.
More Information

Bio Europe Düsseldorf: October 31 - November 02, 2011
Visit us at the Bio Europe and meet with our partners in drug development. 
Attendees: Dr. Koos Burggraaf, Dr. Geert Jan Groeneveld, Wolf Ondracek

 





Trials & Techniques

Bronchodilation with RPL554 in asthmatics maintained with daily dosing
Verona Pharma plc has successfully completed a Phase II study at CHDR to test the duration of bronchodilator action with repeated doses of its lead drug, RPL554, in patients with mild asthma. The trial successfully demonstrated that RPL554 had sustained bronchodilator actions throughout the treatment period.
More Information
Rob Zuiker

Large biosimilar study in oncology therapeutic area
Innovative ways are explored to test complicated biological compound for its safety, tolerability, immunological profile and PK profile. The techniques used in this biosimilar trial ensure a maximally informative trial that can be performed at an optimally fast pace fast and provides high quality data. This was appreciated by regulators as the time for ethical approval was only 18 days emphasizing the flexibility and efficient regulatory climate in The Netherlands.
Joannes Reijers



Posters, Presentations & Publications

Population pharmacokinetic and pharmacodynamic analysis of cortisol in serum and saliva in healthy males after 5-hydroxytryptophan challenge test
A PK/PD model has been developed that describes and predicts serum cortisol concentration for the proposed serotonin dose level in the challenge test. The results provide a rationale to sample cortisol from saliva instead of serum, even after acute stimulation of the hypothalamic-pituitary-adrenal axis.
Zheng Guan

Participation International Cannabinoid Research Society conference
At the International Cannabinoid Research Society conference 2011 in July in
St. Charles, Illinois, USA, Linda Klumpers gave an oral presentation on
"Demonstrating peripheral restriction of CB1 antagonist TM38837 in humans".
She will also present this study in an oral presentation on Sept 10th at the
International Association of Cannabinoids in Medicine conference in Bonn, Germany. 
More Information
 
Predicting treatment response to galantamine
This pharmacological study aims to investigate the correlation between the response to a cholinergic challenge and the clinical respose to treatment with a cholinesterase inhibitor in patients with mild to moderate Alzheimer’s Disease.
Anne Catrien Baakman


Publications

Metoclopramide as pharmacological tool to assess vasopressinergic co-activation of the hypothalamus-pituitary-adrenal (HPA) axis: a study in healthy volunteers.
Jacobs GE, Hulskotte EG, de Kam ML, Zha G, Jiang J, Hu P, Zhao Q, van Pelt J, Goekoop JG, Zitman FG, van Gerven JM.
Eur Neuropsychopharmacol. 2010 ;20:866-874.
The dopamine-2-(D2)-antagonist metoclopramide safely induces HPA-axis activation by itself, and potently synergized 5-HTP-induced corticotrophinergic activation of the HPA axis. These findings are indicative of vasopressinergic co-activation and suggest a role for metoclopramide as a practical function test for co-activation of the HPA axis.

A pharmacological tool to assess vasopressinergic co-activation of the hypothalamus-pituitary-adrenal axis more integrally in healthy volunteers.
Jacobs GE, van Gerven JM, de Kam M, Elassaiss-Schaap J, Ruigt G, van Pelt J, Peeters BW, Peeters PA, Hulskotte EG.
J Psychopharmacol. 2011 ;25:361-369.
This study examined whether (1) concomitant administration of dDAVP and hCRH provides more informative vasopressinergic co-activation than dDAVP alone; and (2) whether the administration of dDAVP followed two hours later by hCRH can quantify both vasopressinergic and corticotrophinergic activation on a single test day. Combining 10 µg dDAVP with 10 µg hCRH induced the potentially most informative vasopressinergic co-activation since it is not restricted by ceiling or flooring effects.

Central nervous system effects of the interaction between risperidone (single dose) and the 5-HT6 antagonist SB742457 (repeated doses) in healthy men.
Liem-Moolenaar M, Rad M, Zamuner S, Cohen AF, Lemme F, Franson KL, van Gerven JM, Pich EM.
Br J Clin Pharmacol. 2011 ;71:907-916.
As the combination of risperidone and SB-742457 may constitute a reasonable combination in cognitively impaired patients, pharmacodynamic interaction effects were investigated in this study. The only significant drug-drug interaction was a small increase of electroencephalogram (EEG) alpha and beta bands. Additionally, this study provided an extensive multidimensional pharmacodynamic profile of risperidone in healthy volunteers, showing that this antipsychotic suppresses motor performance (eye-hand coordination, finger tapping and postural stability), alertness, memory and neurophysiological functions (saccadic eye movements and EEG power spectrum).

Acute psychomotor, memory and subjective effects of MDMA and THC co-administration over time in healthy volunteers.
Dumont GJ, van Hasselt JG, de Kam M, van Gerven JM, Touw DJ, Buitelaar JK, Verkes RJ.J Psychopharmacol. 2011 ;25:478-489
The acute effects of co-administration of MDMA and THC were assessed (the main psychoactive compound of cannabis) on pharmacokinetics, psychomotor performance, memory and subjective experience over time.  Co-administration of THC with MDMA did not exacerbate single drug effects on cognitive function. However, it increased desired subjective drug effects and drug strength compared with the MDMA condition, which may explain the widespread use of this combination.

 

Contact us:
Marieke van den Bosch
Business Development Manager
+31 - 71 - 5246 487
bd@chdr.nl
www.chdr.nl

Subscribe to Newsletter

 ]]>

 

 

 

New CHDR building Update: Breaking of ground ceremony has been a great success

Together, the mayor of Leiden, Henri Lenferink, and the Rector Magnificus of Leiden University, professor Paul van der Heijden, drove the first pile and called it a symbol of the cooperation between CHDR, Leiden University and the community of Leiden. With champagne and live music, 250 employees, family, neighbors and friends celebrated the big event.
With his new building CHDR creates extra capacity to do research and offer volunteers more facilities such as a private room. Adam Cohen: ‘This is a lot more comfortable for the subjects, and it will be much more appealing for new volunteers. They are crucial to our research’.
More Information

 

 

 

 

 

CCMO Annual Report 2010
The Competent Authority of the Netherlands, the CCMO (Central Committee on Research Involving Human Subjects), has published its annual report of 2010. One of the CCMO’s mandates is to oversee accredited
MREC’s (Medical research ethics committees) based on reports, incidents or negative outcomes of clinical scientific research. For the CCMO, the year 2010 was explicitly dedicated to this task.
More Information

Grant to investigate novel functional imaging markers of dementia
Prof. Joop van Gerven, research director of CNS research, has received a ‘Brain Function and Dysfunction over the Lifespan’ grant from Leiden University to investigate novel functional markers of dementia using pharmacological resting state FMRI. Using this technique the brain’s responses will be explored after administration of challenge agents that target specific neurotransmitter systems. RS-FMRI is a promising new technique, which has recently shown drug-induced changes in CNS network activities, which were closely associated with the pharmacological actions of different classes of compounds.
More Information

Bio Europe Düsseldorf: October 31 - November 02, 2011
Visit us at the Bio Europe and meet with our partners in drug development. 
Attendees: Dr. Koos Burggraaf, Dr. Geert Jan Groeneveld, Wolf Ondracek

 





Trials & Techniques

Bronchodilation with RPL554 in asthmatics maintained with daily dosing
Verona Pharma plc has successfully completed a Phase II study at CHDR to test the duration of bronchodilator action with repeated doses of its lead drug, RPL554, in patients with mild asthma. The trial successfully demonstrated that RPL554 had sustained bronchodilator actions throughout the treatment period.
More Information
Rob Zuiker

Large biosimilar study in oncology therapeutic area
Innovative ways are explored to test complicated biological compound for its safety, tolerability, immunological profile and PK profile. The techniques used in this biosimilar trial ensure a maximally informative trial that can be performed at an optimally fast pace fast and provides high quality data. This was appreciated by regulators as the time for ethical approval was only 18 days emphasizing the flexibility and efficient regulatory climate in The Netherlands.
Joannes Reijers



Posters, Presentations & Publications

Population pharmacokinetic and pharmacodynamic analysis of cortisol in serum and saliva in healthy males after 5-hydroxytryptophan challenge test
A PK/PD model has been developed that describes and predicts serum cortisol concentration for the proposed serotonin dose level in the challenge test. The results provide a rationale to sample cortisol from saliva instead of serum, even after acute stimulation of the hypothalamic-pituitary-adrenal axis.
Zheng Guan

Participation International Cannabinoid Research Society conference
At the International Cannabinoid Research Society conference 2011 in July in
St. Charles, Illinois, USA, Linda Klumpers gave an oral presentation on
"Demonstrating peripheral restriction of CB1 antagonist TM38837 in humans".
She will also present this study in an oral presentation on Sept 10th at the
International Association of Cannabinoids in Medicine conference in Bonn, Germany. 
More Information
 
Predicting treatment response to galantamine
This pharmacological study aims to investigate the correlation between the response to a cholinergic challenge and the clinical respose to treatment with a cholinesterase inhibitor in patients with mild to moderate Alzheimer’s Disease.
Anne Catrien Baakman


Publications

Metoclopramide as pharmacological tool to assess vasopressinergic co-activation of the hypothalamus-pituitary-adrenal (HPA) axis: a study in healthy volunteers.
Jacobs GE, Hulskotte EG, de Kam ML, Zha G, Jiang J, Hu P, Zhao Q, van Pelt J, Goekoop JG, Zitman FG, van Gerven JM.
Eur Neuropsychopharmacol. 2010 ;20:866-874.
The dopamine-2-(D2)-antagonist metoclopramide safely induces HPA-axis activation by itself, and potently synergized 5-HTP-induced corticotrophinergic activation of the HPA axis. These findings are indicative of vasopressinergic co-activation and suggest a role for metoclopramide as a practical function test for co-activation of the HPA axis.

A pharmacological tool to assess vasopressinergic co-activation of the hypothalamus-pituitary-adrenal axis more integrally in healthy volunteers.
Jacobs GE, van Gerven JM, de Kam M, Elassaiss-Schaap J, Ruigt G, van Pelt J, Peeters BW, Peeters PA, Hulskotte EG.
J Psychopharmacol. 2011 ;25:361-369.
This study examined whether (1) concomitant administration of dDAVP and hCRH provides more informative vasopressinergic co-activation than dDAVP alone; and (2) whether the administration of dDAVP followed two hours later by hCRH can quantify both vasopressinergic and corticotrophinergic activation on a single test day. Combining 10 µg dDAVP with 10 µg hCRH induced the potentially most informative vasopressinergic co-activation since it is not restricted by ceiling or flooring effects.

Central nervous system effects of the interaction between risperidone (single dose) and the 5-HT6 antagonist SB742457 (repeated doses) in healthy men.
Liem-Moolenaar M, Rad M, Zamuner S, Cohen AF, Lemme F, Franson KL, van Gerven JM, Pich EM.
Br J Clin Pharmacol. 2011 ;71:907-916.
As the combination of risperidone and SB-742457 may constitute a reasonable combination in cognitively impaired patients, pharmacodynamic interaction effects were investigated in this study. The only significant drug-drug interaction was a small increase of electroencephalogram (EEG) alpha and beta bands. Additionally, this study provided an extensive multidimensional pharmacodynamic profile of risperidone in healthy volunteers, showing that this antipsychotic suppresses motor performance (eye-hand coordination, finger tapping and postural stability), alertness, memory and neurophysiological functions (saccadic eye movements and EEG power spectrum).

Acute psychomotor, memory and subjective effects of MDMA and THC co-administration over time in healthy volunteers.
Dumont GJ, van Hasselt JG, de Kam M, van Gerven JM, Touw DJ, Buitelaar JK, Verkes RJ.J Psychopharmacol. 2011 ;25:478-489
The acute effects of co-administration of MDMA and THC were assessed (the main psychoactive compound of cannabis) on pharmacokinetics, psychomotor performance, memory and subjective experience over time.  Co-administration of THC with MDMA did not exacerbate single drug effects on cognitive function. However, it increased desired subjective drug effects and drug strength compared with the MDMA condition, which may explain the widespread use of this combination.

 

Contact us:
Marieke van den Bosch
Business Development Manager
+31 - 71 - 5246 487
bd@chdr.nl
www.chdr.nl

Subscribe to Newsletter

 ]]> 2011-09-12T15:55:29+02:00