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 Newsletter CHDR Winter 2009
 Bridging studies
A longstanding relation between the Japan Clinical Pharmacology Network for Global Trials (J-CLIPNET) and CHDR was formalized by signing a Memorandum of Understanding on Nov 16 2009 which emphasizes the commitment of both organisations and the contribution of mutual research and education.
Within the J-CLIPNET consortium, CHDR has performed highly efficient bridging studies using the same protocol in both countries simultaneously. Also, several Japanese pharmacologists received their training at CHDR.
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Exciting research & student exchange with the University of Adelaide
Newly signed agreements will promote the collaborative research between CHDR and the School of Medical Sciences, University of Adelaide in Australia. The agreement will encourage research collaboration such as the shared utilisation of the NeuroCart.
Furthermore, a Student Exchange Program has been set up where research projects in the field of clinical pharmacology are offered. Students enrolled in the Schools of Medical Sciences are eligible to participate in a research exchange program and receive credit for their studies.
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Leiden Bio Science Park best business park 2009
 Leiden Bio Science Park was awarded best business park of the Netherlands in 2009. Leiden won the prize for its daring choice to specialize in biomedical life science and making a success out of it.
Leiden Bio Science Park is celebrating her 25th anniversary this year. Since 1984, the park has grown into the largest biomedical life science park in the Netherlands, hosting approximately 60 companies. These companies range from listed multinationals to young start-ups that are involved in the development of innovative medicines, therapies and medical devices.
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Trials and Techniques
Translational medicine of glucose regulation
As part of a scientific collaboration with Roche, a translational medicinal project has started which, as a start, will focus on metabolic diseases.
Besides glucose regulation, (subclinical) inflammation and endothelial function will be characterized as there are clear indications that inflammatory processes play an important role in the pathology of certain metabolic diseases. The obtained data will be compared to data in healthy volunteers to obtain a translational model. Furthermore, within the project, there will be ample opportunities that may help to identify novel targets for pharmacological treatment.
This scientific partnering enhances knowledge in both clinical as well as pathology areas and are believed to be the key to success in drug development.
Marloes van Dongen
NeuroSIPE
CHDR together with its collaborative partners have been part of 2 successful STW , NeuroSIPE grants.
The programme has the aim to develop diagnostic tools for neurological disorders. The two innovative programmes involve studies focused on Pain (PAINSIGHT) and Postural Stability (BALROOM), respectively.
Justin Hay
New formulation of an SSRI
Two studies of a serotonin reuptake inhibitor will be conducted to investigate the pharmacokinetic profile of a new formulation of the antidepressant drug, the orally dispersible tablet, compared to the current formulations. Besides pharmacokinetics, the safety, tolerability and perception of the new formulation will be investigated. The benefit of the orally dispersible tablet is to overcome problems in swallowing.
Tijmen Bostoen
Publications, presentations & posters
 On October 13th 2009 Amita Sandhu presented the poster: "Meta-analysis exploring covariate effects on pharmacokinetics, pharmacodynamics and adverse effects of 9-tetrahydrocannabinol (THC) in humans" during the FIGON Dutch Medicines Days 2009, Lunteren, Netherlands.
Pharmacokinetics and pharmacodynamics of the erythropoietin Mimetibody construct CNTO 528 in healthy subjects.
Perez-Ruixo JJ, Krzyzanski W, Bouman-Thio E, Miller B, Jang H, Bai SA, Zhou H, Yohrling J, Cohen A, Burggraaf J, Franson K, Davis HM.
Clin Pharmacokinet. 2009; 48: 601-613.
Anaemia is a serious comorbidity that is common in patients with renal failure or cancer. CNTO 528 is the first Mimetibody developed to mimic the effects of erythropoietin (EPO), a hormone that stimulates the production of red blood cells (RBCs). This publication shows the pharmacokinetic and pharmacodynamic model for CNTO 528 in healthy male subjects. The qualified model is deemed appropriate to conduct clinical trial simulations and to support the decision-making process for dose selection in studies of EPO-stimulating agents.
Intrathecal glycine for pain and dystonia in complex regional pain syndrome.
Munts AG, van der Plas AA, Voormolen JH, Marinus J, Teepe-Twiss IM, Onkenhout W, van Gerven JM, van Hilten JJ.
Pain. 2009; 146: 199-204.
Aims of the current study were to evaluate the safety and efficacy of intrathecal glycine (ITG) administration which may be a potential therapy for both pain and movement disorders in patients with complex regional pain syndrome (CRPS). Efficacy measures involved pain, movement disorders, activity, a clinical global impression and patient's global impression score.
Although there was a trend to worsening on both global impression scores during ITG treatment, there were no significant differences between ITG and placebo treatment in any of the outcomes. 
Central nervous system effects of alcohol at a pseudo-steady-state concentration using alcohol clamping in healthy volunteers.
Zoethout RW, Schoemaker RC, Zuurman L, van Pelt H, Dahan A, Cohen AF, van Gerven JM.
Br J Clin Pharmacol. 2009; 68: 524-534.
The aim of this study was to test a range of central nervous system (CNS) effects under pseudo-steady-state conditions. Most CNS effects of alcohol showed a trend to change over time, despite stable concentrations. Other variables remained stable under pseudo-steady-state conditions.
Key steps for integrating a basic science throughout a medical school curriculum using an e-learning approach.
Dubois EA, Franson KL.
Med Teach. 2009; 31: 822-828.
The process of integrating basic science via e-learning resembles a curricular change. The change usually begins with an idea for using e-learning to teach a basic science and establishing the need for the innovation. A project team is assembled to determine the content of the e-learning program and linking the program to existing course activities. The success of the integration is demonstrated by a positive assessment of the program including favourable cost-benefit analysis and improved student performance. Lastly, continuously updating content and evaluating the integration contribute to the prolonged survival of the e-learning program.
Creating a culture of thoughtful prescribing.
Franson KL, Dubois EA, de Kam ML, Burggraaf J, Cohen AF.
Med Teach. 2009; 31: 415-419.
This publication describes the development of the Individualized Therapy Evaluation and Plan (ITEP) for therapeutic decision-making and communication based on the subjective objective assessment and plan note. The aim of ITEP is to introduce a structured format for creating and communicating therapeutic plans and to provide for students opportunities practice and feedback on their abilities.
Contact info
Marieke van den Bosch
Business Development Manager
+31 - 71 - 5246 487
bd@chdr.nl
www.chdr.nl
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