Pharmacokinetic Modeling and Dose Selection in a Randomized, Double-Blind, Placebo-Controlled Trial of a Human Recombinant Alkaline Phosphatase in Healthy Volunteers

Clinical Pharmacokinetics

Volumn 55, Issue 10, 2016, Pages 1227-1237

  Peters, Esther ^a   Heuberger, Jules A A C ^b   Tiessen, Renger ^c   van Elsas, Andrea ^d   Masereeuw, Rosalinde ^a,e   Arend, Jacques ^d   Stevens, Jasper ^b   Pickkers, Peter ^a  

^a RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^b CENTRE FOR HUMAN DRUG RESEARCH   (Netherlands)

^c PRA HEALTH SCIENCES   (United States)

^d AM Pharma   (Netherlands)

^e UTRECHT UNIVERSITY   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ALKALINE PHOSPHATASE; DRUG ANTIBODY; RECOMBINANT ENZYME; RECOMBINANT PROTEIN;

ADULT; ARTICLE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG DOSE INCREASE; DRUG ELIMINATION; DRUG SAFETY; DRUG TOLERABILITY; ENZYME ACTIVITY; ENZYME BLOOD LEVEL; FEMALE; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROCESS MODEL; RANDOMIZED CONTROLLED TRIAL; ADOLESCENT; ANCESTRY GROUP; BIOLOGICAL MODEL; BODY MASS; CLINICAL TRIAL; COMPUTER SIMULATION; DOSE RESPONSE; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; YOUNG ADULT;

ADOLESCENT; ADULT; ALKALINE PHOSPHATASE; BODY MASS INDEX; COMPUTER SIMULATION; CONTINENTAL POPULATION GROUPS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HEALTHY VOLUNTEERS; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; RECOMBINANT PROTEINS; YOUNG ADULT;

EID: 84965063858     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.1007/s40262-016-0399-y     Document Type: Article

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