On the anticipation of the human dose in first-in-man trials from preclinical and prior clinical information in early drug development

Xenobiotica

Volumn 37, Issue 10-11, 2007, Pages 1331-1354

  Lowe, P J ^a   Hijazi, Y ^a   Luttringer, O ^a   Yin, H ^a   Sarangapani, R ^a   Howard, D ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Absorption; Bioavailability; Clearance; Design of Phase I clinical trials; Pharmacokinetic pharmacodynamic (PKPD) integration; Preclinical; Prediction of first dose in man; Species differences

Indexed keywords

ALBUMIN; IMMUNOGLOBULIN G; SULFONYLUREA;

ANTICIPATION; DOSE RESPONSE; DRUG ABSORPTION; DRUG DEVELOPMENT; DRUG DISTRIBUTION; DRUG EXCRETION; DRUG METABOLISM; HUMAN; IN VITRO STUDY; IN VIVO STUDY; MEDICAL INFORMATION; METHODOLOGY; NONHUMAN; PREDICTION; REVIEW; SPECIES DIFFERENCE;

ANIMALS; BIOLOGICAL TRANSPORT, ACTIVE; CLINICAL TRIALS, PHASE I AS TOPIC; DRUG DESIGN; HUMANS; MODELS, BIOLOGICAL; PHARMACEUTICAL PREPARATIONS; XENOBIOTICS;

ANIMALIA;

EID: 35648945837     PISSN: 00498254     EISSN: 13665928     Source Type: Journal    
DOI: 10.1080/00498250701648008     Document Type: Review

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