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Étude comparative sur la procédure de demande de nouveaux médicaments aux états-unis, en ue et en inde

Étude comparative sur la procédure de demande de nouveaux médicaments aux états-unis, en ue et en inde

B. Hemalatha / K. Padmalatha / S. Venkateswara Rao

86,89 €
IVA incluido
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Editorial:
KS OmniScriptum Publishing
Año de edición:
2023
Materia
Farmacología
ISBN:
9786205900376
86,89 €
IVA incluido
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La mise au point d’un nouveau médicament nécessite de nombreux travaux de recherche en chimie, en fabrication, en science préclinique et en essais cliniques. Les examinateurs des agences de réglementation du monde entier ont la responsabilité d’évaluer si les données de recherche soutiennent la sécurité, l’efficacité et le contrôle de la qualité d’un nouveau produit pharmaceutique pour servir la santé publique. Chaque pays possède sa propre autorité de réglementation, qui est chargée d’appliquer les règles et réglementations et de publier des lignes directrices pour réglementer la commercialisation des médicaments. Ce livre se concentre sur le processus d’approbation des demandes de nouveaux médicaments (NDA) dans différents pays tels que les États-Unis, l’Europe et l’Inde.

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