Guidance for industry [[electronic resource] ] : nonsterile semisolid dosage forms : scale-up and postapproval changes : chemistry, manufacturing, and controls : in vitro release testing and in vivo bioequivalence documentation
Pubbl/distr/stampa
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [1997]
Descrizione fisica
1 electronic resource (30) pages
Soggetti
Drugs - Dosage forms - United States - Testing
Drugs - Therapeutic equivalency - Documentation - United States