Metabolite Bioanalysis in Drug Development: IQ Recommendations
Metabolite Bioanalysis in Drug Development: Recommendations from the IQ Metabolite Bioanalysis WG
Thursday, May 2, 2024
11:00 AM - 12:15 PM ET
Agenda
The webinar aims to provide a brief overview of the IQ Consortium's Metabolite Bioanalysis Working Group, highlighting the key themes in the group's recently published whitepaper. This whitepaper calls attention to the considerations surrounding the trigger, timing, and rigor of fit-for-purpose bioanalysis in the various assessments to address unique challenges that metabolites pose in terms of efficacy and safety during different stages of drug development.
The webinar will cover a wide range of assessments, starting from IND enabling studies, and progressing through Phase I, Phase II, and Phase III clinical trials up to regulatory submission. The recommended approaches ensure that important drug metabolites are identified in a timely manner and properly characterized for efficient drug development. A panel comprised of the working group members will address questions.
Speakers
Wenkui Li, Novartis, PhD
Faye Vazvaei-Smith, MS
Moderator
Gordon Dear, PhD