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.

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.

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Bibliographic Details
Imprint:Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [1997]
Description:1 electronic resource (ii, 36, 6, 6 pages)
Language:English
Subject:
Solid dosage forms -- United States -- Testing.
Drugs -- Therapeutic equivalency -- Documentation -- United States.
Format: E-Resource U.S. Federal Government Document Book
URL for this record:http://pi.lib.uchicago.edu/1001/cat/bib/8006684
Hidden Bibliographic Details
Varying Form of Title: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
Other authors / contributors:Center for Drug Evaluation and Research (U.S.)
Notes:"CMC 8."
"September 1997."
Includes bibliographical references (page 36).
GPO item no.:0499-T (online)
Govt.docs classification:HE 20.4702:SCA 4/2

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