Implications and opportunities of applying the principles of QbD to analytical measurements

Pharmaceutical Technology Europe

Volumn 22, Issue 2, 2010, Pages 29-36

  Pohl, Matthias ^a   Schweitzer, Mark ^b   Hansen, Gordon ^c   Hanna Brown, Melissa ^d   Borman, Phil ^e   Smith, Kevin ^f   Larew, Jaqueline ^f   Nethercote, Phil ^g  

^a NOVARTIS PHARMA AG   (Switzerland)

^b ABBOTT LABORATORIES   (United States)

^c BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^d PFIZER

^e GLAXOSMITHKLINE   (Australia)

^f Cephalon ^*

^g PhRMA Analytical Technical Group

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; ARTICLE; DRUG INDUSTRY; DRUG MANUFACTURE; HYPOTHESIS; PROCESSING; PRODUCT DEVELOPMENT; VALIDATION STUDY;

EID: 76649108561     PISSN: 01646826     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (2)

1. P. Borman et al., Pharm. Technol., 31(12), 142-152 (2007).
2. USP Ad Hoc Advisory Panel on Inorganic Impurities and Heavy Metal, Stimuli Paper (2008), www.usp.org/pdf/EN/USPNF/2008-04-0InorganicImpuritiesStim. pdf