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book (2)

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1997 (2)

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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.
Author: Center for Drug Evaluation and Research (U.S.)
Year: 1997 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Drugs --- Dosage forms --- Testing. --- Therapeutic equivalency --- Documentation

Book

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.
Author: Center for Drug Evaluation and Research (U.S.)
Year: 1997 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Solid dosage forms --- Drugs --- Testing. --- Therapeutic equivalency --- Documentation

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