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Scurit Du Mdicament: Autorisation de Mise Sur Le March, Effet Indsirable, Agence Europenne Des Mdicaments(French)

Scurit Du Mdicament: Autorisation de Mise Sur Le March, Effet Indsirable, Agence Europenne Des Mdicaments(French)

          
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About the Book

Les achats comprennent une adhsion l'essai gratuite au club de livres de l'diteur, dans lequel vous pouvez choisir parmi plus d'un million d'ouvrages, sans frais. Le livre consiste d'articles Wikipedia sur: Autorisation de Mise Sur le March, Effet Indsirable, Agence Europenne Des Mdicaments, Contamination de L'hparine Chinoise En 2008, Comit de Protection Des Personnes, Pharmacovigilance, Mdicament En Vente Libre. Non illustr. Mises jour gratuites en ligne. Extrait: L'autorisation de mise sur le march ou AMM est l'accord donn un mdicament pour tre commercialis. Lorsqu'un laboratoire pharmaceutique dsire mettre en vente un produit de sant (mdicament, produit d'analyse, etc.), il doit prsenter un dossier auprs de l'autorit comptente du pays concern: agence nationale (telle que l'Agence franaise de scurit sanitaire des produits de sant (AFSSAPS), la Direction gnrale du mdicament (DGM) pour la Belgique ou la Food and Drug Administration (FDA) aux tats-Unis ou europenne avec l'Agence europenne des mdicaments (EMEA). Le mdicament "candidat" l'obtention d'une AMM est examin partir d'un dossier de demande d'autorisation de mise sur le march. Aujourd'hui ce dossier est rdig dans un format standardis: le format CTD (Common Technical Document). Ce format est utilis en Europe, aux tats-Unis et au Japon. Les pays d'Asie utilisent un type de dossier diffrent: l'ASEAN CTD. Un dossier pour une nouvelle molcule comporte des milliers de pages. Il dcrit la fois la fabrication de la substance active (souvent partir de documents type Certificat de conformit la pharmacope europenne ou Drug Master File qui aident l'valuation de la substance), la fabrication du produit fini, les tudes cliniques et non-cliniques. Le dossier peut tre abrg lorsqu'il s'agit d'un mdicament gnrique, d'un mdicament "d'usage mdical bien tabli," ... Certaines informations ne sont alors pas requi...http: //booksllc.net/?l=fr


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Product Details
  • ISBN-13: 9781159949907
  • Publisher: Books LLC
  • Publisher Imprint: Books LLC
  • Height: 152 mm
  • No of Pages: 36
  • Series Title: French
  • Sub Title: Autorisation de Mise Sur Le March, Effet Indsirable, Agence Europenne Des Mdicaments
  • Width: 229 mm
  • ISBN-10: 1159949905
  • Publisher Date: 07 Aug 2010
  • Binding: Paperback
  • Language: French
  • Returnable: N
  • Spine Width: 2 mm
  • Weight: 68 gr


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