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2. 2) FDA, “Guidance for industry, waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system,” Center for Drug Evaluation and Research (CDER), Silver Spring, MD, 2017.
3. 3) EMA, “Guideline on the investigation of bioequivalence,” Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency, 2010.
4. 4) WHO, “Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability,” WHO Technical Report Series, 1003, Annex 6, WHO, Geneve, 2017.
5. 5) International Council for Harmonisation. “Biopharmaceutics Classification System-Based Biowaivers,” 2019.