|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|
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.