Director Eli Lilly and Company Indianapolis, Indiana
Summarize the components of absorption/distribution/metabolism/excretion (ADME) in support of the development of tirzepatide. Describe how ADME data was generated and the results acquired from both nonclinical and clinical aspects. Highlight key contributions of the ADME data that supported the registration of tirzepatide with emphasis on regulatory considerations relevant to large molecules contrasting these with traditional small molecule expectations.
Learning Objectives:
Understand the important decision-driving components of ADME in support of tirzepatide development.
Assess the data requirements for registration of molecules like tirzepatide.
Explore regulatory considerations relevant to large molecules contrasting to traditional small molecules for compounds similar to tirzepatide.
