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 1. Home
 2. Regulatory Information
 3. Search for FDA Guidance Documents
 4. Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral
    Dosage Form Drug Products Containing High Solubility Drug Substances
    Guidance for Industry

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GUIDANCE DOCUMENT


DISSOLUTION TESTING AND ACCEPTANCE CRITERIA FOR IMMEDIATE-RELEASE SOLID ORAL
DOSAGE FORM DRUG PRODUCTS CONTAINING HIGH SOLUBILITY DRUG SUBSTANCES GUIDANCE
FOR INDUSTRY AUGUST 2018

Download the Final Guidance Document Read the Federal Register Notice
Final
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Docket Number: FDA-2018-D-2614 Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability
of a final guidance for industry entitled “Dissolution Testing and Acceptance
Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing
High Solubility Drug Substances.” This guidance has been developed to provide
manufacturers with recommendations for submission of new drug applications
(NDAs), investigational new drug applications (INDs), or abbreviated new drug
applications (ANDAs), as appropriate, for orally administered immediate-release
(IR) drug products that contain highly soluble drug substances. The guidance is
intended to describe when a standard release test and criteria may be used in
lieu of extensive method development and acceptance criteria-setting exercises.

--------------------------------------------------------------------------------


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Rockville, MD 20852

All written comments should be identified with this document's docket number:
FDA-2018-D-2614.


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