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LMWHs Web Confidence Initi@tive

[LMW] Heparins are life-saving antithrombotic medicines of biological origin and unlike most chemically synthesized products, each [LMW] Heparin is structurally unique. The reliability and confidence earned by a given [LMW] Heparin depend on the clinical demonstration of its positive benefit-risk not only in specific indications but also in high risk populations.
 
Immunogenic and bleeding risks potentially associated with a particular [LMW] Heparin may be serious. It is critical for any [LMW] Heparin or its biosimilar variant to undergo head-to-head clinical trials and stringent post-marketing surveillance, whenever appropriate, not only to demonstrate effectiveness but also to ensure that patients’ safety is not compromised.
  • Because there is currently no validated method of duplicating a given [LMW] Heparin without access to the proprietary recipe of the original brand, the respective expertise of the heparinoid manufacturers determines their [LMW] Heparin’s identity.
  • Because [LMW] Heparins are injectable products of biologic origin, a high degree of expertise, responsibility and commitment is required. This exigency must be thoroughly applied throughout the entire process, from the selection of biologic source material, through manufacturing steps, in order to eliminate and prevent potential viral and prion contamination, to the comprehensive traceability system.
 

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