Bioassays for evaluation of medical products derived from bacterial toxins.
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.
Division of Bacteriology, National Institute for Biological Standards and Control, South Mimms, Potters Bar, Hertfordshire EN6 3QG, United Kingdom. thea.sesardic@nibsc.hpa.org.uk
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D000818:Animals; D001427:Bacterial Toxins / Q000494:pharmacology* / Q000592:standards / Q000633:toxicity; D001428:Bacterial Vaccines / Q000494:pharmacology / Q000592:standards / Q000633:toxicity; D001681:Biological Assay / Q000592:standards; D002460:Cell Line; D006801:Humans
D001427:Bacterial Toxins; D001428:Bacterial Vaccines