A rational approach for setting and maintaining specifications for biological and biotechnology-derived products: Part 3

BioPharm International

Volumn 21, Issue 8, 2008, Pages

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

^a MERCK RESEARCH LABORATORIES   (United States)

^b AMGEN INC   (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

BIOLOGICAL PRODUCT; DRUG;

ARTICLE; BIOTECHNOLOGICAL PRODUCTION; DRUG EFFICACY; DRUG INDUSTRY; DRUG LABELING; DRUG MANUFACTURE; DRUG MARKETING; DRUG PACKAGING; DRUG SAFETY; DRUG STABILITY; DRUG STORAGE; EXPIRATION DATE; FOOD AND DRUG ADMINISTRATION; INFORMATION PROCESSING; LEGAL ASPECT; PROCESS MONITORING; PROCESS OPTIMIZATION; PRODUCT DEVELOPMENT; QUALITY CONTROL; RISK MANAGEMENT; SHELF LIFE; STANDARD;

EID: 51049121103     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (2)

1. Montgomery DC. Introduction to Statistical Quality Control. New York: John Wiley & Sons; 1991.
2. Fairweather WR, Mogg R, Bennett PS, Zhong J, Morrisey C, Schofield TL. Monitoring the stability of human vaccines, J Biopharm Statistics. 2003;13,395-413.