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Drugs and Health Products
Bioavailability and Bioequivalence
- Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies [2012-05-22]
- Guidance Document: Comparative Bioavailability Standards: Formulations use for Systemic Effects [2012-05-22]
- Bioequivalence Requirements: Critical Dose Drugs [2006-05-31]
- Notice to Industry - Bioequivalence Requirements for Drugs for Which an Early Time of Onset or Rapid Rate of Absorption Is Important (rapid onset drugs) [2005-06-22]
- Notice to Industry - Bioequivalence Requirements for Long Half-life Drugs [2005-06-22]
- Guidance for Industry: Bioequivalence Requirements: Comparative Bioavailability Studies Conducted in the Fed State [2005-06-08]
- Draft Guidance for Industry: Use of Metabolite Data in Comparative Bioavailability Studies [2004-05-28]
- Notice: Draft Guidance for Industry - Preparation of Comparative Bioavailability Information for Drugs Submissions in the CTD Format [2004-05-18]
- Notice to Industry - Bioequivalence Requirements for Combination Drug Products [2004-06-03]
- Notice to Industry - Removal of Requirement for 15% Random Replicate Samples [2003-09-24]
- Draft Guidance for Industry: Clinical Trial Applications for Comparative Bioavailability Studies for Pharmaceuticals [2001-10-09]
- Conduct and analysis of bioavailability and bioequivalence studies Part A: Oral Dosage Formulations Used for Systemic Effects [1997-10-08]
- Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part B: Oral Modified Release Formulations [1996-11-10]
- Report C: Report on Bioavailability of Oral Dosage Formulations, not in Modified Release Form, of Drugs Used for Systemic Effects, Having Complicated or Variable Pharmacokinetics [1992-12-15]
