BioSim Event for Regulatory Scientists - Hands-on Workshops on Modelling & Simulation in Drug Develo
Venue: The Sheffield Marriott Hotel
|Event Date/Time: Jun 13, 2007|
Description of the Courses:
• Concepts: 24th-25th September
• Applications: 27th-28th September
Modelling and Simulation (M&S) is used increasingly to facilitate the process of drug development by informing better study design, identifying selected groups of individuals or conditions that may require special attention, and identifying theoretically conceivable extreme cases which are not amenable to
clinical testing yet are informative regarding labelling issues.
The first workshop will cover issues related to in vitro – in vivo extrapolation (IVIVE) of metabolic clearance (CL), metabolic drug-drug interactions (DDIs), inter-individual variability (due to age, ethnicity, CYP genotypes, and diseases such as renal failure and cirrhosis, etc.).
The second course focuses on dose non-linearity, trial design, assessing oral drug absorption and volume of distribution.
For further information please contact:
Amin Rostami, University of Sheffield (firstname.lastname@example.org), Jan Welink, Medicines Evaluation Board
(email@example.com), or Susan Lundie, Simcyp Limited (firstname.lastname@example.org)