EMA: Guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins (draft)

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.