THE CONTROL AND STANDARDIZATION OF BIOLOGICAL MEDICINES

Assuring the quality, safety and efficacy of the complex medicinal dru gs known as 'biologicals' has many facets of importance to public heal th. This survey covers the historical basis of this area of medical sc ience through current issues and practices to the anticipation of futu re challenges. The key role of the World Health Organization in promot ing international biological standardisation and of biostatistics in t he design and analysis of biological assays is emphasised. Examples of the importance of quality control and standardisation are drawn espec ially from the fields of bacterial and viral vaccines. Assurance of th e quality of these is essential for the successful implementation of c hildhood vaccination programmes aimed at the reduction and eradication of communicable diseases worldwide.