The issue of metabolite bioanalysis has been a subject of many discussions and conferences within the industry. The challenges with metabolite bioanalysis especially in early stage of drug development was first discussed at the Crystal City III meeting and a tiered or fit-for-purpose approach for metabolite bioanalysis had been discussed since then, and the approach was captured in the FDA 2108 Bioanalytical Method Validation guidance. However, there is still a lack of clarity on the details of which metabolite(s) needs to be assayed with what quality rigor and in which studies especially when used to support modeling and simulation to support drug development. For risk aversion, the industry tends to include metabolite bioanalysis in every study once a validated or qualified method is available. The intent of this symposium is to have a discussion around metabolite bioanalysis, 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, and bring in the modeling perspectives, biotransformation perspectives, and regulatory perspectives (or a panel discussion). This first talk will focus on modeling and simulation perspectives and the bioanalytical considerations for the use of data in models for informed decision making in drug development.
Learning Objectives:
Understand the challenges encountered in the metabolite characterization and bioanalysis in drug development.
Understand the fit-for-purpose assays adequate to support stage-appropriate modeling and simulation.
Understand how metabolite data are used to build models
