Impact of modelling intra-subject variability on tests based on non-linear mixed-effects models in cross-over pharmacokinetic trials with application to the interaction of tenofovir on atazanavir in HIV patients

Statistics in Medicine

Volumn 26, Issue 6, 2007, Pages 1268-1284

  Panhard, Xavière ^a,d,e   Taburet, Anne Marie ^b   Piketti, Christophe ^c   Mentré, France ^a,d,e  

^a INSERM   (France)

^b BICÊTRE HOSPITAL   (France)

^c HÔPITAL EUROPÉEN GEORGES POMPIDOU   (France)

^d BICHAT HOSPITAL   (France)

^e UNIVERSITÉ PARIS DESCARTES   (France)

Author keywords

Bioequivalence; Cross over pharmacokinetic trials; Drug drug interactions; Non linear mixed effects models

Indexed keywords

ANTIRETROVIRUS AGENT; ATAZANAVIR; PROTEINASE INHIBITOR; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; TENOFOVIR DISOPROXIL;

ANALYTICAL ERROR; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG POTENTIATION; DRUG TREATMENT FAILURE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; RANDOMIZED CONTROLLED TRIAL; SIMULATION; SINGLE DRUG DOSE; STATISTICAL MODEL;

EID: 33847741777     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.2622     Document Type: Article

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