About this document
Guideline Non Clinical and Clinical Development Similar Biological Medicinal Products Containing Low Molecular Weight Heparins Revision 1 en by Hien Luong is a document available to read on EtoBox.
The document outlines guidelines for the non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins (LMWHs), emphasizing the need for comprehensive quality comparisons and pharmacodynamic studies. It highlights that demonstration of biosimilarity can rely on strong physicochemical data rather than mandatory comparative clinical trials, with specific requirements for non-clinical studies and pharmacovigilance. The guideline is intended to ensure sa
- Author
- Hien Luong
- Language
- EN