Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system

Collection: Health Policy and Services Research Series Title(s): Guidance for industry Contributor(s): 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. Publication: Silver Spring, MD : Center for Drug Evaluation and Research, December 2017 Language(s): English Format: Text Subject(s): Biological Availability Drugs, Investigational -- pharmacokinetics Investigational New Drug Application Therapeutic Equivalency United States United States. Department of Health and Human Services United States. Food and Drug Administration Genre(s): Guideline Technical Report Copyright: The National Library of Medicine believes this item to be in the public domain. (More information) Extent: 1 online resource (1 PDF file (i, 16 pages)). NLM Unique ID: 101720038 (See catalog record) Permanent Link: http://resource.nlm.nih.gov/101720038