Risk assessment in extrapolation of pharmacokinetics from preclinical data to humans

Clinical Pharmacokinetics

Volumn 49, Issue 9, 2010, Pages 619-632

  Teitelbaum, Zvi ^a,b   Lave, Thierry ^c   Freijer, Jan ^d   Cohen, Adam F ^a  

^a CENTRE FOR HUMAN DRUG RESEARCH   (Netherlands)

^b ISRAEL INSTITUTE FOR BIOLOGICAL RESEARCH   (Israel)

^c F HOFFMANN LA ROCHE LTD   (Switzerland)

^d Astellas Pharma Global Development   (Netherlands)

Author keywords

Dose prediction; Pharmacodynamic modelling; Population pharmacokinetics

Indexed keywords

ALLOMETRY; AREA UNDER THE CURVE; ARTICLE; BOOTSTRAPPING; DATA ANALYSIS; DRUG CLEARANCE; DRUG HALF LIFE; HUMAN; MATHEMATICAL MODEL; MAXIMUM PLASMA CONCENTRATION; PLASMA CONCENTRATION-TIME CURVE; PREDICTION; PRIORITY JOURNAL; PROBABILITY; RISK ASSESSMENT; TIME TO MAXIMUM PLASMA CONCENTRATION;

ANIMALS; DRUG EVALUATION, PRECLINICAL; HUMANS; MODELS, BIOLOGICAL; PHARMACOKINETICS; RISK ASSESSMENT;

EID: 77955438759     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.2165/11533760-000000000-00000     Document Type: Article

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