Quality control clinical development plan

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. 

Official standards are absolutely necessary to ensure the quality, reliability, and homogeneity of herbal products for consumers. Standardized products are paramount to those in healthcare planning to conduct clinical research with these products. Independent laboratories and university-affiliated research reports have documented the considerable variation that exists in terms of quality and reliability in these products. Abroad, the ESCOP, composed of manufacturers of herbal medicines and herbal associations, is working with European research groups to develop quality-control standards for the production of natural products. This committee is developing monographs for incorporation into such references as the British Herbal Pharmacopoeia and the British Herbal Compendium. 

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