A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion

AAPS Journal

Volumn 17, Issue 4, 2015, Pages 891-901

  Jiang, Wenlei ^a   Makhlouf, Fairouz ^a   Schuirmann, Donald J ^a   Zhang, Xinyuan ^a   Zheng, Nan ^a   Conner, Dale ^a   Yu, Lawrence X ^a   Lionberger, Robert ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

generic drugs; narrow therapeutic index (NTI) drugs; reference scaled average bioequivalence; within subject variability

Indexed keywords

GENERIC DRUG;

ALGORITHM; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CALCULATION; COMPARATIVE STUDY; CRITERION VARIABLE; GEOMETRY; MATHEMATICAL ANALYSIS; MATHEMATICAL MODEL; MAXIMUM PLASMA CONCENTRATION; NORMAL DISTRIBUTION; SIMULATION; COMPUTER SIMULATION; CROSSOVER PROCEDURE; HUMAN; THERAPEUTIC EQUIVALENCE;

COMPUTER SIMULATION; CROSS-OVER STUDIES; DRUGS, GENERIC; HUMANS; THERAPEUTIC EQUIVALENCY;

EID: 84931561968     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-015-9753-5     Document Type: Article

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