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Biopharmaceutics
Below is a sortable listing of Biopharmaceutics Guidances
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Category
Title
Type
Date
Biopharmaceutics
Bioanalytical Method Validation
(PDF - 63KB)
Final Guidance
05/01/01
Biopharmaceutics
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action
(PDF - 519KB)
Draft Guidance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Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999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Draft Guidance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
Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations
(PDF - 395KB)
Final Guidance
03/01/03
Bioequivalance Recommendation
Clozapine_19758
(PDF - 89KB)
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.
(PDF - 143KB)
Final Guidance
08/01/00
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