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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 Biopharmaceutics, Office of Pharmaceutical Quality. We are providing the Dissolution Methods Database to aid industry personnel in developing generic drug products.
The Inactive Ingredient Database provides information on inactive ingredients present in FDA-approved drug products. This information can be used by industry as an aid in developing drug products. For new drug development purposes, once an inactive ingredient has appeared in an approved drug product for a particular route of administration, the inactive ingredient is not considered new and may require a less extensive review the next time it is included in a new drug product. For example, if a particular inactive ingredient has been approved in a certain dosage form at a certain potency, a sponsor could consider it safe for use in a similar manner for a similar type of product.Reference
DISCLAIMER BY FDA: The Dissolution Methods Database has been prepared by the Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration. The dissolution methods contained in the database are recommended methods that are not binding on FDA or others. FDA will consider alternate methods when supported by appropriate data. We recognize that the database contains a large amount of material, and methods and specifications may change over time. FDA welcomes comments or suggested changes to the database. FDA plans to revise the web site on an ongoing basis.
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