Drugs

Biopharmaceutics

Below is a sortable listing of Biopharmaceutics Guidances

CategoryTitleTypeDate
Biopharmaceutics Bioanalytical Method Validation Guidance for Industry (PDF - 386KB) Final Guidance 05/21/18
Biopharmaceutics Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (PDF - 727KB) Draft Guidance 04/03/03
Biopharmaceutics Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999 (PDF - 191KB) Draft Guidance 04/11/03
Biopharmaceutics Topical Dermatologic Corticosteroids: in Vivo Bioequivalence (PDF - 2.6MB) Final Guidane 06/02/95
Biopharmaceutics Dissolution Testing of Immediate Release Solid Oral Dosage Forms (PDF - 130KB) Final Guidance 08/01/97
Biopharmaceutics Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations (PDF - 170KB) Final Guidance 09/01/97
Biopharmaceutics Food-Effect Bioavailability and Fed Bioequivalence Studies (PDF - 217KB) Final Guidance 12/01/02
Biopharmaceutics Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro (PDF - 744KB) Final Guidance 06/27/89
Biopharmaceutics Statistical Approaches to Establishing Bioequivalence (PDF - 130KB) Final Guidance 02/01/01
Biopharmaceutics Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. Guidance for Industry (PDF - 161KB) Final Guidance 12/22/17
Biopharmaceutics Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (PDF - 128KB) Draft Guidance 12/04/13
Biopharmaceutics Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations (PDF - 805KB) Draft Guidance 03/17/14
Biopharmaceuticals Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances Guidance for Industry (PDF - 103KB) Final Guidance 08/08/18

Page Last Updated: 08/08/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English