Bioequivalence waiver

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 Implications for waiver of bioavailability and bioequivalence studies (Unpublished).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. 

Centre for Drug Evaluation FDA (2000). Waiver of In Vivo Bio availability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutical Classification System. Guidance for industry. 2000. 

The publication of the U.S. FDA Guidelines allowing the waiver of bioequivalence study for compounds classified as Class I based on the Biopharmaceutics Classification System... 

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. 

Waiver of in vivo bioequivalence studies for major post approval manufacturing changes for the BCS Class I (Biopharmaceutics Classification System highly soluble, highly permeable and rapidly dissolving) solid oral products is NOT recommended for narrow therapeutic index drugs (17). 

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