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The International Council for Harmonisation has issued draft guidance specifying the supportive data needed to classify a drug substance under the Biopharmaceutics Classification System and for biowaiver applications.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

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