WHO/BS/2019.2366 Appendix 1a - Phase 1 study protocol: 1st WHO IS for Insulin, Human

Overview

The current WHO standards for insulin (human – coded 83/500, bovine – coded 83/511, porcine – coded 83/515) were established in the mid 1980’s. Their potencies are defined in IU/mg. The assignment of value to the current human insulin standard was based on a multi method collaborative study by in vivo bioassay, hence the need for an updated standard(s) to reflect the transition of insulin internationally to a well-characterized, mass-balance assigned molecule. With this in mind, a new preparation of insulin has been filled into ampoules (NIBSC code 11/212) following procedures recommended by WHO. It is now intended to set up an international collaborative study with expert laboratories to aid in the value assignment of the proposed IS.