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How to demonstrate the bioequivalence of sulodexide [Design Issues]

posted by bjkim97 - Korea / Seoul, 2018-05-30 08:41  - Posting: # 18828
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We are planning to development of the sulodexide.

As far as I Know, this product does not have accurate guldelines and design.

So I have reviewed several documents. The FDA and EMEA have identified guidelines for LMWH.

The sulodexide is defined as follows.

Sulodexide is highly purifuled mixture of glycosaminoglycans composed of FMH (Fast Moving Heparin) (80%) and Dermatan sulfate (20%).

I will refer to the FDA enoxaparin recommend guidelines for pharmacodynamic equivalence.

Just one question:
I am not sure if enoxaparin recommendations can be applied to Sulodexide.

I want to hear your opinion. Please give me your opinion

Thanks.

BJ

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