Quality by design: The next phase

BioProcess International

Volumn 7, Issue 1, 2009, Pages 34-42

  Mire Sluis, Anthony ^a   Schenerman, Mark ^b   Mhatre, Rohin ^c   Advant, Siddharth ^d   Dougherty, John ^e   Kozlowski, Steven ^f   Nashabeh, Wassim ^g   McLeod, Lorna D ^b  

^a AMGEN INC   (United States)

^b MedIimmune ^*

^c BIOGEN   (United States)

^d Tunnell Consulting Inc   (United States)

^e ELI LILLY AND COMPANY   (United States)

^f FDA's Center for Drug Evaluation and Research

^g GENENTECH INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; VALIDATION PROCESS;

EID: 77953364987     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review

References (0)