Metabolite Bioanalysis in Drug Development: Recommendations from the IQ Consortium Metabolite Bioanalysis Working Group

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.PMID:38073140 | DOI:10.1002/cpt.3144

Source: Clinical Pharmacology and Therapeutics - December 11, 2023 Category: Drugs & Pharmacology Authors: Wenkui Li Faye Vazvaei-Smith Gordon 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 Sophia Xu Source Type: research