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Generic and Commercial Low Molecular Weight Heparins

animal models, followed by thrombosis and bleeding models in animals. When the results of such studies are available for review by regulatory agencies, approval for human phase I studies for toxicity, including bleeding, must be done before efficacy studies are proposed. Phase I studies for bleeding in the human are essential before any other studies are done. Bleeding in animal models of low-molecular-weight heparin therapy have been shown in the past not to correlate with heparininduced bleeding. Platelet binding may be a factor. Pharmacokinetic and pharmacodynamic studies in human volunteers should be performed before proceeding to a human bleeding study. An orthopedic surgery trial could be used to show equivalence or not in terms of bleeding risk. The same studies, plus studies in venous thromboembolism patients as well as cardiovascular patients may be needed to show efficacy. This question should not be faced until the bleeding studies are completed.