Model-based analyses of bioequivalence crossover trials using the stochastic approximation expectation maximisation algorithm

Statistics in Medicine

Volumn 30, Issue 21, 2011, Pages 2582-2600

  Dubois, Anne ^a   Lavielle, Marc ^b   Gsteiger, Sandro ^c   Pigeolet, Etienne ^c   Mentré, France ^a  

^a INSERM   (France)

^b INRIA SACLAY   (France)

^c NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Likelihood ratio test; Noncompartmental bioequivalence analysis; Nonlinear mixed effects model; Pharmacokinetics; Two one sided tests; Wald test

Indexed keywords

HUMAN GROWTH HORMONE; THEOPHYLLINE;

ALGORITHM; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG SOLUTION; HUMAN; INTERMETHOD COMPARISON; MAXIMUM PLASMA CONCENTRATION; NONCOMPARTMENTAL ANALYSIS; NONLINEAR MIXED EFFECT MODEL; NONLINEAR SYSTEM; SAMPLING ERROR; SINGLE DRUG DOSE; STATISTICAL ANALYSIS; STATISTICAL MODEL;

ALGORITHMS; BIAS (EPIDEMIOLOGY); CLINICAL TRIALS AS TOPIC; COMPUTER SIMULATION; CROSS-OVER STUDIES; HUMAN GROWTH HORMONE; HUMANS; MODELS, BIOLOGICAL; MODELS, STATISTICAL; NONLINEAR DYNAMICS; THERAPEUTIC EQUIVALENCY;

EID: 80051877714     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.4286     Document Type: Article

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