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Master Thesis

Rationnel de développement et stratégie d'enregistrement d'Odanacatib dans le traitement de l'ostéoporose post-ménopausique

Abstract : Post-menopausal osteoporosis is from now on recognized as an incapacitating disease, with serious consequences -bones fractures- who lead to a deterioration of life quality and a loss of independence, droving to an early death for the majority of the patients. The complications appear as soon as the first fracture arrived, an early diagnosis and the fast implementation of a treatment is essential to slow down this spiral of complications. The prevalence of the post-menopausal osteoporosis, which is strongly connected to the ageing of the population, is increasing in the developed countries and with regard to the future demographic perspectives, this pathology will become a world plague within 2050. Multiple medicines are actually on the market. Nevertheless, they present inconveniences in terms of side effects and/or limits in terms of cost. Odanacatib, new molecule develop by Merck, hast crossed successfully the phase III of the clinical trials. A new pharmacological way was investigated: those of the inhibitors of the cathepsine K. The rational of development of this future medicine takes place upstream to very expensive clinical trials and has to be relevant. Also, the registration strategy of this future medicine must be reflected at early stage of his circle of life, in a purpose of profitability of these. Furthermore, the registration strategy must be planned at the beginning of the drug's lifetime, in order to optimize both its short-term and mid-term profitability. Many factors will influence the choice of the registration strategy, such as epidemiology, cultural background, demography of the chosen countries. The economic and political context, the health system, the health governmental strategy, the drug market, the local regulations, and the laboratory's turnover will also be taken into account.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-00862144
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Submitted on : Monday, September 16, 2013 - 10:26:56 AM
Last modification on : Tuesday, May 11, 2021 - 11:36:17 AM
Long-term archiving on: : Friday, December 20, 2013 - 1:41:43 PM

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  • HAL Id : dumas-00862144, version 1

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Sigrid Andrä. Rationnel de développement et stratégie d'enregistrement d'Odanacatib dans le traitement de l'ostéoporose post-ménopausique. Sciences pharmaceutiques. 2013. ⟨dumas-00862144⟩

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