Vaccine toxicology adjuvants

Sun Y, Gruber M, Matsumoto M (2012) Overview of global regulatory toxicology requirements for vaccines and adjuvants. J Pharmacol Toxicol Methods 65 49-57 Tsusaki H, Yonamine H, Tamai A et al (2005) Evaluation of cardiac function in primates using real-time three-dimensional echocardiography as applications to safety assessment. J Pharmacol Toxicol Methods 52 182-187... 

No adjuvant is licensed as a medicinal product in its own right, but only as a component of a particular vaccine. Therefore preclinical and toxicology studies need to be designed on a case-by-case basis to evaluate the safety profile of the adjuvant and adjuvant/ vaccine combination [60], Evaluation in preclinical studies is important for identifying the optimum composition and formulation process and also for allowing development of tests for quality control [61]. Data from these studies also helps plan protocols for subsequent clinical trials from which safety and efficacy in humans can be evaluated. 

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