Draft guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins

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Download document Draft guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins
Reference number EMEA/CHMP/BMWP/118264/2007 Rev. 1
Status draft: consultation closed
First published 31/01/2013
Last updated 31/01/2013

Summary

This guideline lays down the non-clinical and clinical requirements for low-molecular-weight-heparin (LMWH)-containing medicinal products claiming to be similar to another one already marketed. The non-clinical section addresses the pharmacotoxicological requirements and the clinical section the requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as pharmacovigilance aspects.