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ICH Consults On Harmonized Criteria For Bioequivalence Study Waivers

 
• By Vibha Sharma

The International Council for Harmonisation has issued draft guidance specifying the supportive data needed to classify a drug substance under the Biopharmaceutics Classification System and for biowaiver applications.

BIOEQUIVALENCE STUDY
ICH Guideline Can Reduce Unnecessary Bioequivalence Studies • Source: Shutterstock

The International Council for Harmonisation is inviting feedback on a draft guideline that aims to address the current differences in global requirements for biowaiver under the biopharmaceutics classification system (BCS).

The BCS is a scientific approach based on the aqueous solubility and intestinal permeability characteristics of a drug substance and its use can reduce the need for in vivo bioequivalence...

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