title: Incurred sample reanalysis in bioequivalence studies for abbreviated new drug applications.
authors.affiliation: Division of Bioequivalence II, Office of Generic Drugs, Food & Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Sriram
authors.initials: S
authors.lastname: Subramaniam
authors.forename: Ethan
authors.initials: E
authors.lastname: Stier
authors.forename: Barbara M
authors.initials: BM
authors.lastname: Davit
mesh_terms: D017277:Drug Approval; D004364:Pharmaceutical Preparations; D018401:Sample Size; D013223:Statistics as Topic; D013810:Therapeutic Equivalency
chemical_list: D004364:Pharmaceutical Preparations
keywords: abbreviated new drug applications; bioanalysis; bioequivalence studies; incurred sample reanalysis