Kuldeep Namdev
☆    

India,
2013-10-31 06:58
(4621 d 20:20 ago)

Posting: # 11832
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 Fondaparinux Bioequivalence Study Design [Design Issues]

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Please suggest about the bioequivalence (BE) study design of Fondaparinux.
For USFDA/EMEA submission, whether the BE study designed shall be based on PD (pharmacodynamic) parameters like for low molecular weight heparins eg. Enoxaprin, Dalteparin etc. or required an approach based on pharmacokinetic parameters (Cmax, AUC).
 
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