Utility of physiologically based absorption modeling in implementing quality by design in drug development

AAPS Journal

Volumn 13, Issue 1, 2011, Pages 59-71

  Zhang, Xinyuan ^a   Lionberger, Robert A ^a   Davit, Barbara M ^a   Yu, Lawrence X ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Advanced compartmental absorption and transit (ACAT) model; Gastroplus ; Modified release (MR); Quality by design (QbD)

Indexed keywords

CARBAMAZEPINE;

ARTICLE; BIOEQUIVALENCE; COMPUTER SIMULATION; CONTROLLED RELEASE FORMULATION; DIET RESTRICTION; DRUG ABSORPTION; DRUG CAPSULE; DRUG DESIGN; DRUG DEVELOPMENT; DRUG DOSAGE FORM COMPARISON; DRUG FORMULATION; DRUG SOLUBILITY; FOOD INTAKE; MATHEMATICAL MODEL; MAXIMUM PLASMA CONCENTRATION; SUSPENSION; TABLET FORMULATION; TIME TO MAXIMUM PLASMA CONCENTRATION;

ABSORPTION; ALGORITHMS; ANTICONVULSANTS; CAPSULES; CARBAMAZEPINE; CHEMISTRY, PHARMACEUTICAL; COMPUTER SIMULATION; DOSAGE FORMS; DRUG DESIGN; FASTING; FOOD-DRUG INTERACTIONS; HUMANS; INTESTINAL ABSORPTION; MODELS, BIOLOGICAL; MODELS, STATISTICAL; PHARMACOKINETICS; QUALITY IMPROVEMENT; SOLUBILITY; SUSPENSIONS; TABLETS; THERAPEUTIC EQUIVALENCY;

EID: 79951997007     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-010-9250-9     Document Type: Article

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