Bioassays for evaluation of medical products derived from bacterial toxins.

Thea Sesardic

Current opinion in microbiology 2012 Jun

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Bioassays play central role in evaluation of biological products and those derived from bacterial toxins often rely exclusively on in vivo models for assurance of safety and potency. This chapter reviews existing regulatory approved methods designed to provide information on potency and safety of complex biological medicines with an insight into strategies considered for alternative procedures. Copyright © 2012 Elsevier Ltd. All rights reserved.