| Literature DB >> 22651974 |
Abstract
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.Entities:
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Year: 2012 PMID: 22651974 DOI: 10.1016/j.mib.2012.05.008
Source DB: PubMed Journal: Curr Opin Microbiol ISSN: 1369-5274 Impact factor: 7.934