Drugs
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Dissolution Methods Database
For a drug product that does not have a dissolution test method in the United States Pharmacopeia (USP), the FDA Dissolution Methods Database provides information on dissolution methods presently recommended by the Division of Bioequivalence, Office of Generic Drugs.
Update frequency: Quarterly
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Additional Information
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Dissolution Methods Database Search -
Dissolution Methods Database Frequently Asked Questions - 08/01/1997
Dissolution Testing of Immediate Release Solid Oral Dosage Forms (PDF - 130KB) - 09/01/1997
Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations (PDF - 170KB) - 08/01/2000
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. (PDF - 143KB) - 11/01/1995
SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (PDF - 60KB) - 10/06/1997
SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (PDF - 215KB) - 05/01/1997
SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (PDF - 118KB)
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