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ICH Proposes Harmonized Bioequivalence Standards For Solid Oral Drugs

 
• By Vibha Sharma

The first document of a three-part series of ICH guidelines on conducting bioequivalence studies for orally administered immediate-release solid oral dosage forms has been issued for stakeholder consultation.

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Existing national and international guidelines have different requirements for bioequivalence study design and data analysis • Source: Shutterstock

The International Council for Harmonisation has proposed standardized bioequivalence study requirements for immediate-release solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules and granules/powders for oral suspension.

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