Li, Wenkui, Vazvaei-Smith, Faye, Dear, Gordon, Boer, Jason, Cuyckens, Filip, Fraier, Daniela, Liang, Yuexia, Lu, Ding, Mangus, Heidi, Moliner, Patricia, Pedersen, Mette L., Romeo, Andrea A., Spracklin, Douglas K., Wagner, David S., Winter, Serge and Xu, Xiaohui (Sophia) (2023) Metabolite Bioanalysis in Drug Development: Recommendations from the IQ Consortium Metabolite Bioanalysis Working Group. Clinical Pharmacology & Therapeutics. ISSN 0009-92361532-6535

Abstract

The intent of this perspective is to share the recommendations of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium) Metabolite Bioanalysis Working Group (WG) 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 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.

Item Type:	Article
Keywords:	Metabolite(s), Bioanalysis, Exploratory method, Qualified method, Validated method, Pharmacologically active metabolite(s), Pharmacologically inactive metabolite(s), Borderline metabolite(s), hADME (human ADME) study, MIST (Metabolites in Safety Testing), DDI (Drug-drug Interaction), Chiral metabolite(s), Potency, PAI (Pharmacological activity index), Metabolite exposure coverage, in vitro study, in vivo study, TDRM (Total drug related material), TR (Total radioactivity).
Date Deposited:	02 Jan 2024 00:45
Last Modified:	02 Jan 2024 00:45
URI:	https://oak.novartis.com/id/eprint/49727