CPSA Shanghai 2012

From Bench to Decision Making - From Basics to Application

April 25 - 27, 2012
Renaissance Shanghai Pudong Hotel
Shanghai, China

Abstract

Friday

Metabolite Data in Regulatory Submission

Session Chairs:
Ron Kong, PTC Therapeutics
Andy Ayrton, Scinovo/GlaxoSmithKline
Zheming Gu, XenoBiotics Laboratories

With the recent publications of FDA MIST and ICH M3 guidance, EMA/CHMP Guideline on the Investigation of Drug Interactions, and the most recent FDA draft guidance on DDI, the expectations to characterize the metabolites and understand the potential safety and clinical impact have been raised dramatically. This workshop focuses on the analytical tools and techniques used to characterize the metabolite and current practices and strategies to assess pharmacokinetic, pharmacodynamic, and toxicological effects of metabolites from regulatory considerations. This workshop highlights presentations by leading experts in drug metabolism and pharmacokinetics and bioanalysis from US, Europe, and China, who will share the real-world experience and provide critical insights and strategies to address issues and future trends. The speakers are Drs. Naidong Weng (Director and Head of East Coast Bioanalysis, Janssen Research & Development), Dafang Zhong (Professor at Shanghai Institute of Materia Medica), Martin J Jørrgensen (Divisional Director, Drug ADME Research, Lundbeck A/S).