Quality by design for analytical methods: Implications for method validation and transfer

Pharmaceutical Technology

Volumn 36, Issue 10, 2012, Pages 74-79

  Nethercote, Phil ^a   Ermer, Joachim ^b  

^a GLAXOSMITHKLINE   (United Kingdom)

^b Sanofi   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; ANALYTIC METHOD; ARTICLE; CONCEPTUAL FRAMEWORK; DESIGN OF EXPERIMENT; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; DRUG STABILITY; EQUIPMENT DESIGN; FOOD AND DRUG ADMINISTRATION; GOOD LABORATORY PRACTICE; METHODOLOGY; QUALITY BY DESIGN; QUALITY CONTROL; REPRODUCIBILITY; RISK ASSESSMENT; VALIDATION PROCESS;

EID: 84869994259     PISSN: 15432521     EISSN: 21507376     Source Type: Journal    
DOI: None     Document Type: Article

References (16)

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16. E. Ciurczak, "ICH Guidances (Already) Show Their Age," www.pharmamanufacturing.com/articles/2008/158.html, accessed June 10, 2012. PT