Formulation and Delivery
Jenna Walker, PhD
Senior Advisor
Eli Lilly
Lately, the oral peptide drugs have been focused to develop due to the successful development of Rybelsus and Mycapssa. However, their large molecular weight and stability issue in the GI tract are two major obstacles. In this session, from molecular selection, and permeability evaluation, to formulation development, what is the criteria, reasoning and how those are developed with PK results as well as either clinical PK outcome or regulatory prospective will be presented. Smooth transition from preclinical to clinical, and regulatory aspects will be focused on and the newest in vitro methods including AI learning to evaluate in vivo bioperformance of macropeptides will be introduced.
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