Download or read book Proc dure d enregistrement des m dicaments aux Etats Unis written by Amélie Guerard and published by . This book was released on 2005 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Proc dure d enregistrement aux Etats Unis d un nouveau m dicament par un fabricant fran ais written by Stéphane Simon and published by . This book was released on 1991 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Proc dure d enregistrement d un nouveau m dicament aux tats Unis written by Rémy Jouteux and published by . This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Avant qu'un médicament puisse être administré à un patient il devra passer par plusieurs étapes : le développement pharmaceutique. C'est un processus long allant de la découverte du principe actif à sa commercialisation, en passant par la formulation galénique, aux études pré cliniques et cliniques. A côté de l'aspect scientifique de la recherche, il y a la partie réglementaire qui aide à assurer que le Sponsor d'une étude soit bien en accord avec les recommandations d'un pays donné. Dans cette thèse est abordé l'aspect réglementaire aux États-Unis, à travers les autorisations, tout d'abord d'étudier le produit chez l'homme, puis une fois les données scientifiques positives, de l'enregistrer pour le commercialiser.
Download or read book Developpement et enregistrement d un nouveau m dicament aux Etats Unis written by Véronique Langlet and published by . This book was released on 2004 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt: Le développement d'un médicament aux Etats-Unis implique une étroite collaboration entre le laboratoire pharmaceutique et la Food and Drug Administration (FDA), agence chargée de la sécurité sanitaire et alimentaire délivrant les autorisations de mise sur le marché des médicaments sur le territoire américain. Les deux étapesz primordiales du développement d'un médicament sont la soumission auprès de la FDA de dossiers de demande d'autorisation pour : d'une part, conduire des études cliniques : il s'agit de l'Investigational New Drung (IND) ; d'autre part, obtenir l'autorisation de mise sur le marché : il s'agit de du New Drug Application (NDA). Chacun de ces dossiers, soumis à des moments différents au cours du développement, rassemble toutes les informations connues sur la qualité, la sécurité et l'efficacité du médicament. Dans une première partie sont exposées toutes les étapes qu'un laboratoire doit franchir pour développer une nouvelle entité chimique aux Etats-Unis. La deuxième partie décrit en détail l'IND et le NDA, notamment leur contenu et leur évaluation par le Center for Drug, Evaluation and Researche (CDER), bureau d'évaluation des médicaments autres que biologiques au sein de la FDA.
Download or read book PROCEDURE D ENREGISTREMENT DES MEDICAMENTS AU CANADA written by MARIE-AUDE.. CARDINAUD and published by . This book was released on 1991 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Annuaire Europeen 2000 European Yearbook 2000 written by Francis Rosensteil and published by Martinus Nijhoff Publishers. This book was released on 2001-07-01 with total page 1154 pages. Available in PDF, EPUB and Kindle. Book excerpt: The year 2000's most significant international event was, almost certainly, neither political nor military, but scientific - the announcement, in June, that the human genome had been almost totally decoded. Future generations may well see this as a major turning point, opening the way to radical changes in diagnosis, prognosis, and medical treatment. Often compared with the space programme, this vast enterprise still generates misgivings: this new power, which human beings now have, to modify the genetic heritage of living creatures raises fundamentally new ethical questions - and society as a whole will have to find the answers. In fact, the accelerating pace of scientific and technical progress seems to be reviving atavistic anxieties, some rational, others less so. Recent public-health crises, including the mad cow disease' scare, which lasted into 2000, have fuelled these fears. The public's rejection of GMOs (Genetically Modified Organisms) - verging on a crusade in some countries - tells its own story. As regards conflict, 2000 saw the Middle East peace process grind to a halt, and the Intifada resume. In Europe, the situation in Kosovo and Chechnya, both the scenes of fighting in 1999, stayed precarious. Peace and democracy did score some successes, however, particularly in Europe: the centre-left's victory in Croatia, sweeping former President Tudjman's party off the scene, the democratic party's triumph in Bosnia, and the fall of the Milosevic regime in Serbia.
Download or read book Welcome to the United States written by and published by . This book was released on 2007 with total page 4 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Bio industries written by Canada. Industry Canada and published by Canadian Museum of Civilization/Musee Canadien Des Civilisations. This book was released on 1997 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Treaty Series Recueil Des Traites written by United Nations and published by UN. This book was released on 2007-11-02 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Recueil Des Arr ts Et D cisions written by European Court of Human Rights and published by . This book was released on 2007 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Taking a Multisectoral One Health Approach A Tripartite Guide to Addressing Zoonotic Diseases in Countries written by Food and Agriculture Organization of the United Nations and published by Food & Agriculture Org.. This book was released on 2019-03-11 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 2018 FAO-OIE-WHO (Tripartite) zoonoses guide, “Taking A Multisectoral, One Health Approach: A Tripartite Guide to Addressing Zoonotic Diseases in Countries” (2018 TZG) is being jointly developed to provide member countries with practical guidance on OH approaches to build national mechanisms for multisectoral coordination, communication, and collaboration to address zoonotic disease threats at the animal-human-environment interface. The 2018 TZG updates and expands on the guidance in the one previous jointly-developed, zoonoses-specific guidance document: the 2008 Tripartite “Zoonotic Diseases: A Guide to Establishing Collaboration between Animal and Human Health Sectors at the Country Level”, developed in WHO South-East Asia Region and Western Pacific Region. The 2018 TZG supports building by countries of the resilience and capacity to address emerging and endemic zoonotic diseases such as avian influenza, rabies, Ebola, and Rift Valley fever, as well as food-borne diseases and antimicrobial resistance, and to minimize their impacts on health, livelihoods, and economies. It additionally supports country efforts to implement WHO International Health Regulations (2005) and OIE international standards, to address gaps identified through external and internal health system evaluations, and to achieve targets of the Sustainable Development Goals. The 2018 TZG provides relevant country ministries and agencies with lessons learned and good practices identified from country-level experiences in taking OH approaches for preparedness, prevention, detection and response to zoonotic disease threats, and provides guidance on multisectoral communication, coordination, and collaboration. It informs on regional and country-level OH activities and relevant unisectoral and multisectoral tools available for countries to use.
Download or read book Preventing Regulatory Capture written by Daniel Carpenter and published by Cambridge University Press. This book was released on 2014 with total page 531 pages. Available in PDF, EPUB and Kindle. Book excerpt: Leading scholars from across the social sciences present empirical evidence that the obstacle of regulatory capture is more surmountable than previously thought.
Download or read book EEC Malta Association Agreement and Protocols and Other Basic Texts written by European Economic Community and published by . This book was released on 1992 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Index to the U S Patent Classification written by and published by . This book was released on 1996 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Politics of Global Regulation written by Walter Mattli and published by Princeton University Press. This book was released on 2009-05-17 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Regulation by public and private organizations can be hijacked by special interests or small groups of powerful firms, and nowhere is this easier than at the global level ... This is the first book to examine systematically how and why such hijacking or 'regulatory capture' happens, and how it can be averted."--P. [iv] of cover.
Download or read book The Czechoslovak Republic written by and published by . This book was released on 1919 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Long Acting Animal Health Drug Products written by Michael J. Rathbone and published by Springer Science & Business Media. This book was released on 2012-10-11 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: Long acting veterinary formulations play a significant role in animal health, production and reproduction within the animal health industry. Such technologies offer beneficial advantages to the veterinarian, farmer and pet owner. These advantages have resulted in them growing in popularity in recent years. The pharmaceutical scientist is faced with many challenges when innovating new products in this demanding field of controlled release. This book provides the reader with a comprehensive guide on the theories, applications, and challenges associated with the design and development of long acting veterinary formulations. The authoritative chapters of the book are written by some of the leading experts in the field. The book covers a wide scope of areas including the market influences, preformulation, biopharmaceutics, in vitro drug release testing and specification setting to name but a few. It also provides a detailed overview of the major technological advances made in this area. As a result this book covers everything a formulation scientist in industry or academia, or a student needs to know about this unique drug delivery field to advance health, production and reproduction treatment options and benefits for animals worldwide.
