A rational approach for setting and maintaining specifications for biological and biotechnology-derived products part 1

BioPharm International

Volumn 21, Issue 6, 2008, Pages 42-54

  Apostol, Izydor ^a   Schofield, Timothy ^b   Koeller, Gerhard ^c   Powers, Susan ^d   Stawicki, Mary ^e   Wolfe, Richard A ^d  

^a AMGEN INC   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

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

^d PFIZER INC   (United States)

^e GLAXOSMITHKLINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; BIOTECHNOLOGY; CAPILLARY ELECTROPHORESIS; DRUG MANUFACTURE; GEL PERMEATION CHROMATOGRAPHY; ION EXCHANGE CHROMATOGRAPHY; QUALITY CONTROL; REVIEW; STATISTICAL ANALYSIS;

EID: 47149098423     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (11)

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7. ASTM. Standard Practice for using significant digits in test data to determine conformance with specifications. In ASTM Designation: E 29-04 ed. 2005; p 1-5.
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10. International Conference on Harmonization. Q2R1, Validation of analytical procedures. Geneva, Switzerland; 2005, p 1-13.
11. Ritter NM, Advant SJ, Hennessey J, Simmerman H, McEntire J, Mire-Sluis A, Joneckis C. What Is test method qualification? Proceedings of the WCBP CMC strategy forum, 24 July 2003. BioProcess Int. 2004;2,32-46.