Performance-based quality specifications: The relationship between process critical control parameters, critical quality attributes, and clinical performance

Journal of Pharmaceutical Sciences

Volumn 100, Issue 4, 2011, Pages 1566-1575

  Short, Steven M ^a   Cogdill, Robert P ^b   Drennen III, James K ^a   Anderson, Carl A ^a  

^a DUQUESNE UNIVERSITY   (United States)

^b UNIVERSITY OF NEBRASKA LINCOLN   (United States)

Author keywords

Content uniformity; Design space; Dissolution; Monte Carlo; Quality; Quality by design; Risk assessment; Simulations; Theophylline; Toxicity

Indexed keywords

THEOPHYLLINE; TABLET; VASODILATOR AGENT;

ARTICLE; CORRELATION ANALYSIS; DRUG CONTROL; DRUG DESIGN; DRUG EFFICACY; DRUG GRANULATION; DRUG QUALITY; DRUG RELEASE; DRUG SOLUBILITY; MEDICAL LITERATURE; MOISTURE; UNITED STATES; BIOLOGICAL MODEL; CHEMICAL MODEL; CHEMISTRY; COMPUTER AIDED DESIGN; COMPUTER SIMULATION; HUMAN; MONTE CARLO METHOD; QUALITY CONTROL; SOLUBILITY; TABLET; TOXICITY;

COMPUTER SIMULATION; COMPUTER-AIDED DESIGN; DRUG DESIGN; HUMANS; MODELS, BIOLOGICAL; MODELS, CHEMICAL; MONTE CARLO METHOD; QUALITY CONTROL; SOLUBILITY; TABLETS; THEOPHYLLINE; VASODILATOR AGENTS;

EID: 79951920679     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22373     Document Type: Article

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