What question did this study set out to answer?

The aim is to establish a new international standard for heparin by evaluating candidate preparations.

January 1, 1984Thrombosis and Haemostasis25 citations

A Collaborative Study Designed to Establish the 4th International Standard for Heparin

DTD P Thomas ACA. D. M. Curtis TBTrevor W. Barrowcliffe

Key Points

The aim is to establish a new international standard for heparin by evaluating candidate preparations.
Conducted a collaborative study with 22 laboratories analyzing 248 assays.
Assessed potency using APTT, thrombin inhibition, anti-Xa assays, and pharmacopoeial assays.
Compared results to determine the most suitable candidate for standardization.
The candidate preparation 82/502 showed less than 5% difference in mean potency estimates across all assay methods.
Preparation 82/502 demonstrated the closest parallelism to the existing standard based on bioassay.
WHO established preparation 82/502 as the 4th International Standard for Heparin with an assigned unitage of 1780 i.u. per ampoule.

Abstract

An international collaborative study, in which 22 laboratories participated, was carried out to establish a replacement for the International Standard for Heparin. A total of 248 assays were analyzed, including APTT, thrombin inhibition and anti-Xa assays, as well as pharmacopoeial assays. Overall, there was less than 5% difference in the mean potency estimates of the candidate preparations, by all assay methods. The freeze-dried preparation 82/502 demonstrated the closest parallelism by bioassay to the existing standard and was established by WHO as the 4th International Standard for Heparin, with an assigned unitage of 1780 i.u. per ampoule.

AI에게 질문

Bookmark

View Full Paper