Understanding pharmaceutical quality by design

AAPS Journal

Volumn 16, Issue 4, 2014, Pages 771-783

  Yu, Lawrence X ^a   Amidon, Gregory ^b   Khan, Mansoor A ^a   Hoag, Stephen W ^c   Polli, James ^c   Raju, G K ^d,e   Woodcock, Janet ^a  

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

^b UNIVERSITY OF MICHIGAN   (United States)

^c UNIVERSITY OF MARYLAND   (United States)

^d MASSACHUSETTS INSTITUTE OF TECHNOLOGY   (United States)

^e Pharmaceuticals Inc   (United States)

Author keywords

control strategy; critical quality attributes; pharmaceutical quality by design; process understanding; product understanding

Indexed keywords

EXCIPIENT; DRUG;

CONTINUAL IMPROVEMENT; CONTROL STRATEGY; CRITICAL MATERIAL ATTRIBUTE; CRITICAL PROCESS PARAMETER; CRITICAL QUALITY ATTRIBUTE; DATA ANALYSIS; DRUG APPROVAL; DRUG DESIGN; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; EXPERIMENTAL DESIGN; HUMAN; INVESTIGATIVE PROCEDURES; PROCESS ANALYTICAL TECHNOLOGY; PROCESS CAPABILITY; PROCESS DESIGN; PROCESS TECHNOLOGY; PRODUCT PARAMETERS; PRODUCT RECALL; PRODUCT SAFETY; QUALITY TARGET PRODUCT PROFILE; REVIEW; RISK ASSESSMENT; ROOT CAUSE ANALYSIS; MEDICINAL CHEMISTRY; PHARMACEUTICS; STANDARDS; TOTAL QUALITY MANAGEMENT;

CHEMISTRY, PHARMACEUTICAL; DRUG DESIGN; DRUG INDUSTRY; HUMANS; PHARMACEUTICAL PREPARATIONS; QUALITY IMPROVEMENT; TECHNOLOGY, PHARMACEUTICAL;

EID: 84903626070     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-014-9598-3     Document Type: Review

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