Good Planning Practice in Preclinical and Clinical Studies of Unfractionated and Fractionated Heparins in Russia as the Basis of Safe and Effective Anticoagulation Therapy
Gavrishina, E.V.; Dobrovolskii, A.V.; Niyazov, R.R.; Romodanovskii, D.P.; Vasil'ev, A.N.
Eksperimental'naia i Klinicheskaia Farmakologiia 78(11): 15-20
2015
ISSN/ISBN: 0869-2092 PMID: 27017700 Document Number: 684524
General principles of appropriate strategies for preclinical and clinical development of unfractionated and low-molecular-weight heparins and demonstration of their biosimilarity to corresponding reference medicinal products are provided. Demonstration of the biosimilarity of heparin-containing medicinal products constitutes the basis for their efficacy and safety during anticoagulation therapy. The main quality, safety, and efficacy characteristics of heparin products are described and the extent of non-clinical and clinical investigations necessary prior to drug marketing authorization are considered.