ABSTRACT
New biological substances and delivery systems are increasingly being introduced for the prevention, treatment and diagnosis of human diseases. Prior to their use in human populations, all new biological products must undergo preclinical evaluation. These pre-clinical studies are important not only to establish the biological properties of the material and to evaluate its possible risk to the public, but also to plan protocols for subsequent clinical studies from which safety and efficacy can be evaluated. Evaluation in pre-clinical studies, particularly for vaccines, may also be important for identifying the optimum composition required for effective use and may contribute towards the development of manufacturing processes for the production of effective formulations. Quality control evaluation, on the other hand, is designed to ensure satisfactory batch-to-batch consistency of formulations already established as effective in man and licensed for a particular medical application. Both types of evaluation are particularly important for vaccines as these are generally intended to be given to a large proportion of healthy adults and infants.
