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Guidance for industry : 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.

Bibliographic Details
Corporate Author: Center for Drug Evaluation and Research (U.S.)
Format: Government Document eBook
Language:English
Published: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [1997]
Subjects:
Solid dosage forms > United States > Testing.
Drugs > Therapeutic equivalency > Documentation > United States.
Online Access:https://purl.fdlp.gov/GPO/LPS121122
Description
Item Description:"CMC 8."
"September 1997."
Electronic resource.
Physical Description:1 electronic resource (ii, 36, 6, 6 pages)
Bibliography:Includes bibliographical references (page 36).