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.

Format:

Book

Government document

Contributor:

Center for Drug Evaluation and Research (U.S.)

Language:

English

Subjects (All):

Drugs--Dosage forms--United States--Testing.

Drugs.

Drugs--Therapeutic equivalency--Documentation--United States.

Drugs--Dosage forms--Testing.

United States.

Physical Description:

1 electronic resource (30) pages

Other Title:

Nonsterile semisolid dosage forms

Scale-up and postapproval changes

Chemistry, manufacturing, and controls, in vitro release testing and in vivo bioequivalence documentation

Place of Publication:

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [1997]

Notes:

'SUPAC-SS."

"CMC 7."

Includes bibliographical references (29).

OCLC:

587646051