Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system
Guidance for industry
United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Drugs, Investigational -- pharmacokinetics
Investigational New Drug Application
Biopharmaceutics -- classification
Drugs, Investigational -- administration & dosage
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
The National Library of Medicine believes this item to be in the public domain.
1 online resource (1 PDF file (i, 16 pages)).
NLM Unique ID:
See catalog record
Metadata (Dublin Core)