14. August 2015

    Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Dru

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    Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs Guidance for Industry
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    DRAFT GUIDANCE 

    This guidance document is being distributed for comment purposes only. 

    Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. 

    For questions regarding this draft document contact (CDER) Richard Lostritto at 301-796-1667. 

    U.S. Department of Health and Human Services 

    Food and Drug Administration 

    Center for Drug Evaluation and Research (CDER) 

    August 2015 

    Tags: excipient, Solid, Dosage, fda, aug2015, guidance