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[GOOD PLANNING PRACTICE IN PRECLINICAL AND CLINICAL STUDIES OF UNFRACTIONATED AND FRACTIONATED HEPARINS IN RUSSIA AS
This study outlines strategies for developing unfractionated and low-molecular-weight heparins, focusing on demonstrating biosimilarity to reference products. Ensuring biosimilarity is crucial for the safety and efficacy of these anticoagulation therapies.
Area of Science:
- Pharmacology and Drug Development
- Biochemistry and Molecular Biology
Context:
- Development and regulatory approval of heparin products
- Importance of biosimilarity for drug efficacy and safety
Purpose:
- Provide guidance on preclinical and clinical development of heparins
- Outline strategies for demonstrating biosimilarity to reference products
Summary:
- Discusses general principles for developing unfractionated and low-molecular-weight heparins.
- Explains the importance of demonstrating biosimilarity for heparin-containing products.
- Details key quality, safety, and efficacy characteristics, and required investigations for marketing authorization.
Impact:
- Facilitates regulatory approval of biosimilar heparins
- Ensures consistent safety and efficacy of anticoagulation therapies
- Informs future drug development strategies for heparin products
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