Pharmacokinetic similarity of biologics: Analysis using nonlinear mixed-effects modeling

Clinical Pharmacology and Therapeutics

Volumn 91, Issue 2, 2012, Pages 234-242

  Dubois, A ^a   Gsteiger, S ^b   Balser, S ^c   Pigeolet, E ^b   Steimer, J L ^b   Pillai, G ^b   Mentre F ^a  

^a INSERM   (France)

^b NOVARTIS PHARMA AG   (Switzerland)

^c Sandoz Biopharmaceutical Development   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN GROWTH HORMONE; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; COMPARTMENT MODEL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; DRUG FORMULATION; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE;

BIOLOGICAL AGENTS; CLINICAL TRIALS AS TOPIC; ERYTHROPOIETIN; HUMAN GROWTH HORMONE; HUMANS; NONLINEAR DYNAMICS; RECOMBINANT PROTEINS;

EID: 84855960706     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2011.216     Document Type: Article

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