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How to obtain a marketing authorization for an anticoagulant drug
Sang Thrombose Vaisseaux, 05/05/09

Pavlovic M et al. - A Marketing authorization application file must contain complete pharmacokinetic data, non-clinical safety data in animals, pharmacokinetic, pharmacodynamic and interaction data in animals and in healthy volunteers as well as clinical efficacy and safety data in patients corresponding to the claimed indication for the product. In studies aiming to show a biological activity of a new anticoagulant product, the incidence of patients with total complete venous thromboses, both distal and proximal, detected by venography, has been measured. In therapeutic confirmatory trials, the most clinically relevant endpoint to measure efficacy is advocated. Safety data must be confronted with the efficacy data from therapeutic confirmatory trials and for the basis of marketing authorization decision.

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