The section maintains a large catalogue of WHO International Standards and other reference materials for the assessment of endocrine therapeutics. The highly complex and heterogeneous nature of many of these therapeutics, has meant that the relationship between their structure and biological activity is incompletely understood, and in many cases, difficult to predict.  This means that their potency assessment relies on the use of comparative bioassays which include an external reference standard. WHO International Standards are established for this purpose and provide both traceability and consistency in the assignment of potency to endocrine therapeutics. The section also collaborates with the European and US Pharmacopoeias in the production of pharmacopoeial reference materials.

Recently established WHO International Standards for endocrine therapeutics

Current and future standardisation projects for endocrine therapeutics

The full list of reference materials for protein hormones and endocrine products can be found here. The provision of WHO International Standards for both the diagnostic and therapeutic communities relies on the generous donations of materials from manufacturers and other interested parties. We are currently planning collaborative studies to establish replacement standards for prolactin, menotrophin (FSH/LH), proinsulin, C-peptide and recombinant erythropoietin. If you are able to donate materials or wish to participate in the collaborative study for any of these standards then please contact chris.burns@nibsc.hpa.org.uk or melanie.moore@nibsc.hpa.org.uk for more information.