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Guidance for industry : nonsterile semisolid dosage forms : scale-up and postapproval changes : chemistry, manufacturing, and controls : in vitro release 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:
Drugs > Dosage forms > United States > Testing.
Drugs > Therapeutic equivalency > Documentation > United States.
Online Access:https://purl.fdlp.gov/GPO/LPS121136
Description
Item Description:'SUPAC-SS."."
"CMC 7."
Electronic resource.
Physical Description:1 electronic resource (30) pages
Bibliography:Includes bibliographical references (29).