NR APCG
AU Bader,F.; Davis,G.; Dinowitz,M.; Garfinkle,B.; Harvey,J.; Kozak,R.; Lubiniecki,A.; Rubino,M.; Schubert,D.; Wiebe,M.; Woollett,G.
TI Assessment of risk of bovine spongiform encephalopathy in pharmaceutical products, part 1
QU Biopharm - The Technology & Business of Biopharmaceuticals 1998; 11(N1): 20
PT Article
AB The Pharmaceutical Research and Manufacturers of America (PhRMA) is the industry organization that represents member research-based pharmaceutical and biotechnology companies. The Biologicals and Biotechnology Committee within the Science and Regulatory Section of PhRMA focuses on products made through modern biotechnology and products that are complex derivatives of biological processes. In 1992, the Biologicals and Biotechnology Committee established a BSE Committee. Its charter was to monitor developments related to bovine spongiform encephalophathy, educate members through presentations, and interact with FDA and USDA. In 1996, the Committee recognized the need for a scientifically comprehensive method for assessing the risk of BSE in pharmaceutical products. This risk assessment would allow organizations involved in product development and manufacturing to properly assess risk and to evaluate available options for sourcing bovine products to minimize the risk of BSE. This two-part article provides the current guidelines developed by the PhRMA BSE Committee for conducting BSE risk assessment. The guidelines cannot anticipate all possible product-related scenarios or predict future research results related to BSE. Those using the risk assessment guidelines should make modifications where scientifically appropriate and when new information becomes available. This risk assessment method should evoke lively scientific interest and will encourage research to improve methodology and numerical estimates. PhRMA plans to update the risk assessment periodically. It may be useful to hold an international meeting to discuss BSE risk assessment approximately one year after publication of the method.
ZR 55 Zitate
SP englisch