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Zdrowie i gospodarka · 2.06.2025

FDA Announces Draft Guidance for Bioequivalence of Additional Strengths of Immediate-Release Oral Dosage Forms

The FDA has released a draft guidance on bioequivalence for additional strengths of immediate-release oral dosage forms, prepared by the International Council for Harmonisation, with the goal of providing harmonized criteria for drug applications with multiple strengths.

Source: Federal Register — Food and Drug AdministrationOpen original release →