Assuring the quality of vaccines : regulatory requirements for licensing and batch release
Methods in Molecular Medicine
|March 2, 2011
Abstract:
Ensuring the consistent safety and efficacy of a vaccine has long been recognized as an essential element in a successful disease-control program. Indeed, the development of appropriate laboratory methods to characterize a vaccine with respect to its component antigens, safety, and potency must be a prerequisite to the routine clinical use of any new bacterial, viral, or antiparasite vaccines, Adequate control measures serve to safeguard vaccinees both against unacceptable adverse effects and inadequate protection.
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