Bioavailability and bioequivalence studies

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, Food and Drug Administration, issued 8/2000, posted 8/31/2000. http //www.fda.gov/cder/guidance/ index, htm... 

FDA Guidance for Industry Waiver of in vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Containing Certain Active Moieties/ Active Ingredients Based on a Biopharmaceutics Classification System, CDER-GUID 2062dft.wpd Draft, Jan. 1999. 

CDER Waiver of in vivo bioavailability and bioequivalence studies for... 

Crison, G. L. Amidon. pH and surfactant-facilitated in vitro solubilization and dissolution of ketoprofen, a class II drug. Implications for waiver of bioavailability and bioequivalence studies (Unpublished). 

CDER Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system Food and Drug Administration, 2000. 

Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations. Oct. 2000. 

FDA. Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations (Revised) (I). Rockville MD, USA U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 2003. 

FDA Guidance to Industry Bioavailability and bioequivalence studies for orally administered drug products — General considerations, 2002. 

Food and Drug Administration (FDA). Guidance for Industry. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-release Solid Dosage Forms Based on a Biopharmaceutics Classification System. RockviUe, MD FDA, 2000. 

All clinical trials, including bioavailability and bioequivalence studies, shall be designed, conducted and reported in accordance with the principles of good clinical practice. 

Barrett JS Bioavailability and bioequivalence studies. In Bonate PL, Howard DR (Eds.), Pharmacokinetics in Drug Development Clinical Study Design and Analysis, Volume 1. AAPS Press, Arlington,VA (2004). 

Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations. Optional Format PDF (Issued October 2000, Posted October 27, 2000). This guidance should be useful for applicants planning to conduct bioavailability and bioequivalence (BE) studies during the IND period for an NDA, BE studies intended for submission in an ANDA, and BE studies conducted in the postapproval period for certain changes in both NDAs and ANDAs. 

GUIDANCE FOR INDUSTRY1 BIOAVAILABILITY AND BIOEQUIVALENCE STUDIES FOR ORALLY ADMINISTERED DRUG PRODUCTS—GENERAL CONSIDERATIONS (DRAFT GUIDANCE)2... 

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