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What is In-Vitro and In-Vivo Studies in Pharma about?

This document discusses the importance of in-vitro and in-vivo studies in pharmaceutical formulation development. It outlines key concepts like bioavailability, bioequivalence, factors that influence absorption and the measurement of bioavailability. The regulatory requirements for new drugs and generic drugs are compared, highlighting the need for generic drugs to demonstrate bioequivalence to the innovator product through bioequivalence studies. The design of bioequivalence studies and factors to consider

Author

Dan Martínez Silva

Language

EN