Metabolite Bioanalysis in Drug Development: Recommendations from the <scp>IQ</scp> Consortium Metabolite Bioanalysis Working Group
Wenkui Li, Faye Vazvaei‐Smith, Gordon J. Dear, Jason Boer, Filip Cuyckens, Daniela Fraier, Yuexia Liang, Ding Lu, Heidi Mangus, Patricia Moliner, Mette Lund Pedersen, Andrea A. Romeo, Douglas K. Spracklin, David S. Wagner, Serge Winter, Xiaohui Xu
Abstract
The intent of this perspective is to share the recommendations of the International Consortium for Innovation and Quality in Pharmaceutical Development Metabolite Bioanalysis Working Group on the fit-for-purpose metabolite bioanalysis in support of drug development and registration. This report summarizes the considerations for the trigger, timing, and rigor of bioanalysis in the various assessments to address unique challenges due to metabolites, with respect to efficacy and safety, which may arise during drug development from investigational new drug (IND) enabling studies, and phase I, phase II, and phase III clinical trials to regulatory submission. The recommended approaches ensure that important drug metabolites are identified in a timely manner and properly characterized for efficient drug development.