Immunotoxicology

Pharmaceuticals for human use comprise a very wide variety of product types. These include traditional products (i.e. chemically synthesized or derived from natural resources) as well as biological products (such as vaccines and blood products isolated from biological sources) and biotechnology-derived pharmaceuticals (such as peptide/protein products manufactured by recombinant DNA techniques, monoclonal antibodies and gene therapy products). In the interest of the public, these medicinal products are subject to worldwide regulatory control by government authorities. The major objective of this regulation is to ensure that the benefit of the products to the patients is not outweighed by their adverse effects. To achieve this goal, the authorities carefully assess the balance between efficacy and safety. If this balance is positive, they allow marketing. To support applications for marketing authorization, the pharmaceutical industry, therefore, has to submit scientific data which prove that their products are efficacious and acceptably safe in the proposed therapeutic indication. Furthermore, the pharmaceutical quality of the products applied for has to meet high standards.