Journal of Bioequivalence & Bioavailability

The role of modeling and simulations to better understand, optimize and predict Bioequivalence

2^nd World Congress on Bioavailability & Bioequivalence: Pharmaceutical R & D Summit-2011 and International Conference on Pharmaceutics & Novel Drug Delivery Systems

06-08 June 2011, Las Vegas, USA

Murray P. Ducharme

Scientific Tracks Abstracts: JBB

Abstract:

M odeling and simulations have arguably revolutionized the fi eld of clinical pharmacology, enabling clinicians, academicians and regulators to better understand the effi cacy and toxicity of drugs by linking their relationship with exposure metrics. Virtually all new drug submissions nowadays incorporate a modeling and simulation component. In contrast, modeling and simulations are oft en misunderstood and severely underutilized in the bioequivalence fi eld. Th is presentation will review the types of studies, specifi c pharmacokinetic behavior and circumstances in which modeling and simulations can help optimize bioequivalence programmes. Case examples will be shown for drugs with atypical characteristics or specifi c formulations where modeling and simulations can actually optimize the drug development process by predicting or proving bioequivalence using novel methods in a more robust scientifi c manner while decreasing the number or complexity of the clinical studies.

Biography :

Murray P. Ducharme has a pharmacy degree from the University of Montreal, and a post- graduate Pharm.D. from Wayne State University. He has been with Cetero Research since 2007 where he is globally responsible for scienti fi c and regulatory affairs. His research interests have focused on the role of modeling and simulations to better understand the clinical pharmacology of drugs and optimizing the drug development process. Dr. Ducharme has been principal or sub-investigator on thousands of trials, has authored more than 150 articles, abstracts, book chapters and manuals, and has presented internationally more than 200 posters and seminars.