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Guidance for industry : immediate 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.] : Center for Drug Evaluation and Research, [1995]
Subjects:
Solid dosage forms > Testing > Documentation > United States.
Drugs > Therapeutic equivalency > Documentation > United States.
Online Access:https://purl.fdlp.gov/GPO/LPS121078
Description
Item Description:"CMC 5"--prelim. p.
"November 1995."
Electronic resource.
Physical Description:1 electronic resource (26, 1 page)
Bibliography:Includes bibliographical references (pages 25-26).