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Drugs

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Biopharmaceutics

 
 Title and Format  Type  Issue Date
Bioanalytical Method Validation (PDF - 63 KB) Final 5/2001
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (PDF - 519 KB)
Draft 4/2/2003
4/11/2003
Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations (PDF - 268 KB) Final 3/2003
Cholestyramine Powder in Vitro Bioequivalence (PDF - 35 KB) (Intermin Guidance)  Final 7/15/93
Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing (PDF - 78 KB) Final 6/17/2005
Conjugated Estrogens, USP-LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence. Draft
Withdrawn
FR Notice		 8/12/2005
Corticosteroids, Dermatologic (topical) In Vivo (PDF - 3 MB) (Issued 6/2/1995, Posted 3/6/1998) Final 6/2/1995
Dissolution Testing of Immediate Release Solid Oral Dosage Forms (PDF - 130 KB) (Issued 8/1997, Posted 8/25/1997) Final 8/1997
Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations (PDF - 170 KB) Final 9/1997
Food-Effect Bioavailability and Fed Bioequivalence Studies(PDF - 166 KB) Final 12/2002

Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro (PDF - 744 KB)		 Final 6/27/1989
Potassium Chloride (slow-release tablets and capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing  (PDF - 718 KB) Final 6/6/1994
Statistical Approaches to Establishing Bioequivalence (PDF - 130 KB) Final 2/2001
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.(PDF - 143 KB). Final 8/2000
    
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