Product development of probiotics as biological drugs

Clinical Infectious Diseases

Volumn 46, Issue SUPPL. 2, 2008, Pages

  Sutton, Ann ^a  

^a Biologics Consulting Group   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PROBIOTIC AGENT;

ANTIBIOTIC SENSITIVITY; ANTIMICROBIAL ACTIVITY; BACTERIAL STRAIN; BIOLOGICAL THERAPY; CELL CULTURE; CHEMICAL ANALYSIS; CONFERENCE PAPER; DNA HYBRIDIZATION; DRUG CONTAMINATION; DRUG DESIGN; DRUG FORMULATION; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG SAFETY; DRUG STABILITY; GENE SEQUENCE; HUMAN; PRIORITY JOURNAL; QUALITY CONTROL; RNA SEQUENCE; SHELF LIFE; STOMACH PH; YEAST;

BACTERIA; BIOLOGICAL PRODUCTS; CONSUMER PRODUCT SAFETY; DRUG INDUSTRY; HUMANS; PROBIOTICS; QUALITY CONTROL;

EID: 40049099407     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/523325     Document Type: Conference Paper

References (10)

1. Walker RI, Buckley M, eds. Probiotic microbes: the scientific basis. Washington, DC: American Academy of Microbiology, 2006.
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3. Joint FAO/WHO Working Group on Drafting Guidelines for the Evaluation of Probiotics in Food. Guidelines for the evaluation of probiotics in food: report of a Joint FAO/WHO Working Group on Drafting Guidelines for the Evaluation of Probiotics in Food, London, Ontario, Canada, April 30 and May 1, 2002. Available at: http://www.who.int/foodsafety/publications/fs_management/probiotics2/en/ index.html. Accessed 10 December 2007.
4. Lherm T, Monet C, Nougière B, et al. Seven cases of fungemia with Saccharomyces boulardii in critically ill patients. Intensive Care Med 2002; 28:797-801.
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6. United States Pharmacopoeia. Water for pharmaceutical purposes. In: United States Pharmacopoeia - National Formulary. 30th ed. Rockville, Maryland: USPC, 2007:chapter 1231.
7. United States Pharmacopoeia. Microbial limits tests. In: United States Pharmacopoeia - National Formulary. 30th ed. Rockville, Maryland: USPC, 2007:chapter 61.
8. US Food and Drug Administration. Food and drugs: Biologic products: general [600]; Licensing [601]; General biological standards [610]. Code of Federal Regulations title 21, parts 600, 601, and 610, 2006.
9. ICH Expert Working Group. Specifications: test procedures and acceptance criteria for biotechnological/biological products. Guideline Q6B. Available at: http://www.ich.org. Accessed 1 July 2006.
10. US Food and Drug Administration. Food and drugs: General biological products standards: Sterility. Code of Federal Regulations title 21, part 610.12, 2006.