Important (international) Regulatory documents
European Medicines Agency (EMA), Europe
- Guideline on the investigation of Bioequivalence (January 2010): click here
World Health Organization (WHO)
- WHO Expert Committee on Specifications for Pharmaceutical Preparations - Fortieth Report (2006): click here
US Food and Drug Administration (FDA), United States
- Guidance for Industry - Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (August 2000): click here)
- Guidance for Industry - Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations (March 2003 Rev 1): click here
National Institute of Health Sciences (NIHS), Japan
- Guideline for Bioequivalence Studies for Different Strengths of Oral Solid Dosage Forms (2006): click here
- Guideline for Bioequivalence Studies for Formulation Changes of Oral Solid Dosage Forms (2006): click here
- Guideline for Bioequivalence Studies of Generic Products (2006): click here
Federal Service on Surveillance in Healthcare and Social Development of Russian Federation, Russia
- Methodological recommendations for drug manufacturers on in vitro equivalence test for generic drug products according to biowaiver procedure (draft version 2010, click here). Translated with the kind cooperation of Dr I.E. Shohin, Scientific Center for Expertise of Medical Products, Moscow, Russia; I.M. Sechenow First Mocsow State Medical Universtity, Moscow, Russia.
