Interdependence of drug substance physical properties and corresponding quality control strategy

Journal of Pharmaceutical Sciences

Volumn 101, Issue 1, 2012, Pages 312-321

  Cui, Yong ^a   Song, Xiling ^a   Reynolds, Mark ^a   Chuang, King ^a   Xie, Minli ^a  

^a GENENTECH INC   (United States)

Author keywords

Design space; Dissolution; Drug substance; Multivariate analysis; Particle size; Physical characterization; Physical property; Principle component analysis; Quality by design; Solid dosage form

Indexed keywords

ARTICLE; CONTROLLED STUDY; DRUG MANUFACTURE; MULTIVARIATE ANALYSIS; QUALITY CONTROL; UNIVARIATE ANALYSIS;

EID: 82255162691     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22754     Document Type: Article

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