An improved in vivo procedure for standardization of heparin preparations

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Abstract
The WHO International Collaborative Study of the Assay of Heparin has demonstrated the unreliability of present assay methods for heparin. An in vivo assay procedure has been redesigned to use standardized dogs in a crossover assay, measuring three coagulation tests and lipoprotein lipase on nine blood samples for each heparin dose. The procedure was tested with five heparin preparations. By the standard method for parallel line assays regression was significant (P > 0·001) for log2 dose-log10 response. Analyses of variance were satisfactory and estimation of potency statistically valid. The potency of each heparin in International units varied with the parameter used. Fiducial limits were ±10% for anticoagulant parameters, ±15% for antilipaemic parameter and reproducibility, 97% for anticoagulant parameters, 87·5% for antilipaemic parameter.

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