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Title 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.

Imprint [Rockville, Md.] : Center for Drug Evaluation and Research, [1995]

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:D 74/5    ---  Available
Description 1 electronic resource (26, 1 pages)
text txt rdacontent
computer c rdamedia
online resource cr rdacarrier
Note "CMC 5"--Preliminary page.
"November 1995."
Bibliography Includes bibliographical references (pages 25-26).
Subject Solid dosage forms -- Testing -- Documentation -- United States.
Drugs -- Therapeutic equivalency -- Documentation -- United States.
Added Author Center for Drug Evaluation and Research (U.S.)
Added Title Immediate release solid oral dosage forms
Scale-up and postapproval changes, chemistry, manufacturing and controls, in vitro dissolution testing, and in vivo bioequivalence documentation
Gpo Item No. 0499-T-02 (online)
Sudoc No. HE 20.4702:D 74/5

 
    
Available items only