Quality by design: Concepts for ANDAs

AAPS Journal

Volumn 10, Issue 2, 2008, Pages 268-276

  Lionberger, Robert A ^a   Lee, Sau Lawrence ^a   Lee, LaiMing ^a   Raw, Andre ^a   Yu, Lawrence X ^a  

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

Author keywords

Control strategy; Critical material attributes; Critical process parameters; Design space; Quality by design

Indexed keywords

GENERIC DRUG; NEW DRUG;

CONTROL STRATEGY; DRUG DESIGN; DRUG FORMULATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; FEEDBACK SYSTEM; NOMENCLATURE; PHARMACEUTICAL CARE; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; RISK MANAGEMENT; SENSITIVITY ANALYSIS;

DRUG DESIGN; DRUG INDUSTRY; DRUGS, GENERIC; QUALITY CONTROL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 53849130980     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-008-9026-7     Document Type: Review

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