Biological standards in haemostasis and thrombosis.

Abstract

International standards are used to assess the potency of a variety of biological drugs employed in the field of haemostasis and thrombosis. These include therapeutic concentrates for the treatment of inherited coagulation defects, such as haemophilia, thrombolytic drugs such as streptokinase for the treatment of heart attacks, and anticoagulant drugs such as heparin. Some of these standards have existed for over 25 years, and they continue to play a vital role in ensuring consistent potency, and hence safety, of manufactured drugs. The growing complexity of new products, particularly in the area of recombinant technology, represents a continuing challenge for the field of biological standardization.