Minimum safety requirements for preclinical testing.

A wide range of biological products for medicinal use can now be produced by novel biotechnology processes. These products include naturally occurring human proteins and peptides such as hormones, cytokines, blood products as well as monoclonal antibodies of murine and human origin and bacterial and viral antigens for use as vaccines. However, there are potential safety concerns that arise from the novel processes used in their manufacture and from the complex structural and biological characteristics of the products. The acute and repeated dose toxicity testing, pharmacodynamic and immunological testing and a range of product-specific biochemical and safety tests required for these products are described.