Role of metabolites for drugs that undergo nonlinear first-pass effect: Impact on bioequivalency assessment using single-dose simulations

Journal of Pharmaceutical Sciences

Volumn 99, Issue 1, 2010, Pages 515-523

  Braddy, April C ^a   Jackson, Andre J ^b  

^a Center for Drug Evaluation and Research   (United States)

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

Author keywords

Absorption; Bioequivalence; First pass metabolism; Nonlinear pharmacokinetics; Simulations

Indexed keywords

DRUG METABOLITE;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; COMPARTMENT MODEL; CONTROLLED STUDY; DRUG ABSORPTION; DRUG CLEARANCE; FIRST PASS EFFECT; MAXIMUM PLASMA CONCENTRATION; SIMULATION;

EID: 73949138009     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21838     Document Type: Article

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