Problems in the Evaluation of Theoretical Risks for Humans to Become Infected with BSE-Contaminated Bovine-Derived Pharmaceutical Products

  • Maurizio Pocchiari
Part of the Serono Symposia USA Norwell, Massachusetts book series (SERONOSYMP)

Abstract

The safety of bovine-derived pharmaceutical products with respect to bovine spongiform encephalopathy (BSE) has been the topic of several scientific meetings in the last few years (1–13), and although a consensus on the factors that must be considered for their evaluations has been reached, it is still difficult for manufacturers and authorities to defermine an objective estimate of the potential level of BSE contamination for each drug or to allocate precise figures to each risk factor. This chapter weighs each risk factor in order to facilitate uniform application by competent authorities. However, this chapter does not give a magic formula with which to decide whether a product should be kept on, or removed from, the market. The decision regarding the usefulness of a medicinal product should take into consideration not only the estimated potential risk but also, and most important, its inherent benefit.

Keywords

Urea Europe Titration Dura Scrapie 

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Copyright information

© Springer-Verlag New York, Inc. 1996

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  • Maurizio Pocchiari

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