Journal of Bioequivalence & Bioavailability

Current global challenges in the Bioequivalence of CR/MR and Multiphasic formulations of drugs

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 odifi ed release products are becoming more and more sophisticated in their design and release, prompting a careful scientifi c re-evaluation of what pharmacokinetic metrics and statistical tests are needed to make sure that generic products are truly equivalent to their reference counterparts, while ensuring that additional evaluations or tests are not required needlessly. It is therefore crucial that regulatory requirements are scientifi cally sound to protect the public, while allowing access to generic products once market exclusivity and patent protection have elapsed. Th is presentation will be broken up in three parts. A summary of the current requirements from US FDA, Health Canada and EMA will fi rst be reviewed for the diff erent classes of modifi ed release products available. A critical evaluation of these requirements will follow. Case examples will be presented to highlight certain points. Finally, specifi c scientifi c recommendations will be proposed in order to stimulate further discussion and debate on this topic from a global harmonization perspective

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