Quality by design case study: An integrated multivariate approach to drug product and process development

International Journal of Pharmaceutics

Volumn 382, Issue 1-2, 2009, Pages 23-32

  Huang, Jun ^a   Kaul, Goldi ^a   Cai, Chunsheng ^a   Chatlapalli, Ramarao ^a   Hernandez Abad, Pedro ^a   Ghosh, Krishnendu ^a   Nagi, Arwinder ^a  

^a PFIZER INC   (United States)

Author keywords

Critical process parameter (CPP); Critical quality attribute (CQA); Design of experiments (DOEs); Design space; Multivariate data analysis; Quality by design (QbD)

Indexed keywords

DRUG; WATER;

ARTICLE; CASE STUDY; COMPRESSION; CONTROL STRATEGY; CONTROLLED STUDY; DATA ANALYSIS; DRUG DESIGN; DRUG MANUFACTURE; DRUG QUALITY; DRUG SOLUBILITY; LUBRICATION; MULTIVARIATE ANALYSIS; PRIORITY JOURNAL; PROCESS DEVELOPMENT; PROCESS OPTIMIZATION; RESPONSE SURFACE METHOD; WATER CONTENT;

CARBOXYMETHYLCELLULOSE; CELLULOSE; CHEMISTRY, PHARMACEUTICAL; EXCIPIENTS; MODELS, CHEMICAL; MODELS, STATISTICAL; MULTIVARIATE ANALYSIS; PRINCIPAL COMPONENT ANALYSIS; QUALITY CONTROL; SOLUBILITY; STEARIC ACIDS; SYSTEMS INTEGRATION; TABLETS; TECHNOLOGY, PHARMACEUTICAL; TIME FACTORS; WATER;

EID: 70350208809     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2009.07.031     Document Type: Article

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