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Biopharma Companies: |
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FDA Regulations: |
- Bioanalytical Method Validation [HTML]
or [PDF]
(Issued 5/2001, Posted 5/22/2001)
- Bioavailability and Bioequivalence Studies for
Orally Administered Drug Products - General Considerations [Word]
or [PDF]
(Issued 3/2003, Posted 3/19/2003)
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Cholestyramine Powder in Vitro Bioequivalence
(Intermin Guidance)
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Clozapine Tablets in Vivo Bioequivalence and in Vitro
Dissolution Testing
(Issued 11/15/1996, Reposted 10/15/1998)
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Corticosteroids, Dermatologic (topical) In Vivo
(Issued 6/2/1995, Posted 3/6/1998)
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Dissolution Testing of Immediate Release Solid Oral
Dosage Forms
or
WordPerfect 6.x Version (Issued 8/1997, Posted 8/25/1997)
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Extended Release Oral Dosage Forms: Development,
Evaluation, and Application of In Vitro/In Vivo Correlations
(Issued 9/1997, Posted 9/26/1997)
- Food-Effect Bioavailability and Fed
Bioequivalence Studies [Word]
or [PDF]
(Issued 12/2002, Posted 1/30/2003)
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Metaproterenol Sulfate and Albuterol Metered Dose
Inhalers In Vitro
(Issued 6/27/1989, Posted 3/2/1998)
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Phenytoin/Phenytion Sodium (capsules, tablets,
suspension) In Vivo Bioequivalence and In Vitro Dissolution Testing
(Issued 3/4/1994, Posted 3/2/1998)
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Potassium Chloride (slow-release tablets and
capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing
(Revised 6/6/1994, Posted 6/22/1998)
- Statistical Approaches to Establishing
Bioequivalence [HTML]
or [PDF]
(Issued 2/2001, Posted 2/1/2001)
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Waiver of In Vivo Bioavailability and Bioequivalence
Studies for Immediate-Release Solid Oral Dosage Forms Based on a
Biopharmaceutics Classification System.
Optional Format:
PDF.
(Issued 8/2000, Posted 8/31/2000)
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Biogenerics: |
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