An example of optimal phase II design for exposure response modelling

Journal of Pharmacokinetics and Pharmacodynamics

Volumn 37, Issue 5, 2010, Pages 475-491

  Maloney, Alan ^a,b   Schaddelee, Marloes ^c   Freijer, Jan ^c   Krauwinkel, Walter ^c   Van Gelderen, Marcel ^c   Jacqmin, Philippe ^b   Simonsson, Ulrika S H ^a  

^a UPPSALA UNIVERSITY   (Sweden)

^b Exprimo NV   (Belgium)

^c Astellas Pharma Global Development   (Netherlands)

Author keywords

Emax model; Exposure response; Optimal design; Phase II clinical trial

Indexed keywords

DRUG;

ACCURACY; ALGORITHM; ANALYTICAL ERROR; AREA UNDER THE CURVE; ARTICLE; CLINICAL STUDY; DOSE RESPONSE; DRUG RESEARCH; EXPOSURE RESPONSE MODELLING; INTERMETHOD COMPARISON; PRIORITY JOURNAL; PROCESS OPTIMIZATION; PROSPECTIVE STUDY; SAMPLE SIZE; STATISTICAL ANALYSIS; STATISTICAL MODEL; STUDY DESIGN;

ALGORITHMS; AREA UNDER CURVE; CLINICAL TRIALS, PHASE II AS TOPIC; COMPUTER SIMULATION; DATA INTERPRETATION, STATISTICAL; DOSE-RESPONSE RELATIONSHIP, DRUG; ENDPOINT DETERMINATION; HUMANS; MODELS, BIOLOGICAL; RESEARCH DESIGN; SAMPLE SIZE;

EID: 78049394175     PISSN: 1567567X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10928-010-9168-y     Document Type: Article

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