Process combination toxicological studies

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. 

The ubiquitous nature of metals from both natural and anthropogenic sources combined with their necessity in biological processes produce a complex system for study. Metal distributions in abiotic and biotic systems must be examined to accurately assess impact on ecosystems. Wildlife studies of exposure and effect can be challenging, but the results are more complete than evaluation of only metal concentrations. Birds are good sentinel species because they visible, sensitive to toxins, and occupy different trophic positions. Therefore, studies to assess avian population status, reproductive success, and toxicological significance of metal exposures can be extrapolated to other wildlife and possibly humans. 

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