Document details
| 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 open |
| First published | 31/01/2013 |
| Last updated | 31/01/2013 |
| Consultation start date | 31/01/2013 |
| Consultation end date | 31/07/2013 |
| Email address for submissions | bmwp.secretariat@ema.europa.eu |
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.