Utility of physiologically based modeling and preclinical in vitro/in vivo data to mitigate positive food effect in a BCS class 2 compound

AAPS PharmSciTech

Volumn 14, Issue 3, 2013, Pages 1255-1266

  Xia, Binfeng ^a   Heimbach, Tycho ^a   Lin, Tsu Han ^a   Li, Shoufeng ^b   Zhang, Hefei ^b   Sheng, Jennifer ^b   He, Handan ^a  

^a NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH   (United States)

^b NOVARTIS PHARMA AG   (Switzerland)

Author keywords

amorphous formulation; food effects; physiologically based pharmacokinetic (PBPK) modeling; population simulation; precipitation

Indexed keywords

BASE; NVS 123; UNCLASSIFIED DRUG;

ABSORPTION; ADULT; AGED; ANIMAL EXPERIMENT; ARTICLE; BIOEQUIVALENCE; COMPUTER MODEL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DISSOLUTION; DRUG BLOOD LEVEL; EXPERIMENTAL DOG; EXPERIMENTAL MODEL; FEMALE; FOOD; HUMAN; HUMAN EXPERIMENT; IN VITRO STUDY; IN VIVO STUDY; MALE; NONHUMAN; NORMAL HUMAN; PHYSIOLOGICALLY BASED PHARMACOKINETIC MODEL; PRECIPITATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIMULATION;

ADMINISTRATION, ORAL; ANIMALS; CROSS-OVER STUDIES; DOGS; FOOD-DRUG INTERACTIONS; HUMANS; MODELS, BIOLOGICAL; PHARMACOKINETICS; SOLUBILITY;

EID: 84890192826     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-013-0018-2     Document Type: Article

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