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

Available Online