Use of pharmacokinetic/ pharmacodynamic modelling for starting dose selection in first-in-human trials of high-risk biologics

British Journal of Clinical Pharmacology

Volumn 67, Issue 2, 2009, Pages 153-160

  Agoram, Balaji M ^a  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

AMG 114; BIOLOGICAL MARKER; BIOLOGICAL PRODUCT; ERYTHROPOIETIN; ERYTHROPOIETIN RECEPTOR; HEMOGLOBIN; IMMUNOGLOBULIN E; IMMUNOGLOBULIN E ANTIBODY; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; TGN 1412; UNCLASSIFIED DRUG;

ANEMIA; ANTIBODY DEPENDENT CELLULAR CYTOTOXICITY; ANTIBODY ENGINEERING; BIOLOGICAL THERAPY; DOSE CALCULATION; DRUG RECEPTOR BINDING; HUMAN; IN VITRO STUDY; IN VIVO STUDY; MATHEMATICAL COMPUTING; MINIMUM ANTICIPATED BIOLOGICAL EFFECT LEVEL; NOTE; PHARMACOKINETIC PHARMACODYNAMIC MODEL; PREDICTION; PRIORITY JOURNAL; RECEPTOR OCCUPANCY; SIMULATION; THEORETICAL MODEL;

ANTIBODIES, ANTI-IDIOTYPIC; BIOMARKERS, PHARMACOLOGICAL; CLINICAL TRIALS AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG EVALUATION, PRECLINICAL; HUMANS; MODELS, ANIMAL; MODELS, BIOLOGICAL; PHARMACEUTICAL PREPARATIONS;

EID: 61349174522     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2008.03297.x     Document Type: Note

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