Les bonnes pratiques de fabrication dans un département de recherche et développement galénique PDF Download

Author: Marie Dominique Henry
Publisher:
ISBN:
Category :
Languages : fr
Pages : 250

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Author: CORINNE.. CROS DE COCKER
Publisher:
ISBN:
Category :
Languages : fr
Pages :

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Author: Alain Le Hir
Publisher: Elsevier Masson
ISBN: 2994099632
Category : Medical
Languages : fr
Pages : 400

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• La pharmacie galénique est non seulement l'art de préparer, conserver et présenter les nouveaux médicaments, mais aussi une science appliquée aux affinités diverses et à prédominances tantôt technologiques (pharmacotechnie), tantôt biologiques (biodisponibilité) ; • Cette 9e édition a été actualisée et enrichie en fonction des évolutions scientifiques, technologiques, et des apports récents des principaux référentiels de l'enseignement de la pharmacie galénique, à savoir : - Le Guide des bonnes pratiques de fabrication des médicaments de 2007. - Le Guide des bonnes pratiques de préparation de 2007. - La Pharmacopée européenne, 6e édition. - La Pharmacopée française, 10e édition révisée notamment pour le Formulaire National.

Author: Charlotte Becker
Publisher:
ISBN:
Category :
Languages : fr
Pages : 122

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Afin d'assurer la qualité et la sécurité des médicaments fabriqués, l'entreprise doit se doter d'un système d'« assurance de qualité » performant, s'appuyant sur des textes réglementaires tels que « les Bonnes pratiques de fabrication » (BPF). Selon les BPF, un médicament de qualité ne peut être produit que dans des locaux adaptés, avec des équipements qualifiés et par un personnel formé, effectuant les tâches conformément à la documentation et aux instructions écrites. Cependant, certaines exigences des BPF doivent être adaptées dans le cas des médicaments vétérinaires et à plus forte raison lorsque ceux-ci sont destinés à des essais cliniques. Ce travail aborde donc les particularités des BPF appliquées aux médicaments vétérinaires et aux médicaments pour essais cliniques, ainsi que leur mise en œuvre concrète dans la zone de production d'un centre de recherche et développement. Dans ce cadre, la démarche de qualification d'un équipement utilisé dans la production de lots pour essais cliniques, est développée puis illustrée avec l'application à un lit d'air fluidisé.

Author: Fenghe Qiu
Publisher: Academic Press
ISBN: 0128027851
Category : Medical
Languages : en
Pages : 514

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Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides high level strategies for the successful implementation of APS in a pharmaceutical company. It offers scientists and regulators a comprehensive resource on how the pharmaceutical industry can enhance their understanding of a product's stability and predict drug expiry more accurately and quickly. - Provides a comprehensive, one-stop-shop resource for accelerated predictive stability (APS) - Presents the scientific basis of different APS models - Includes the applications and utilities of APS that are demonstrated through numerous case studies - Covers up-to-date regulatory experience

Author: Jacques Fleurentin
Publisher: IRD Editions
ISBN: 9782709910385
Category : Ethnobotany
Languages : fr
Pages : 502

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Author: Astra Taylor
Publisher: The New Press
ISBN: 1595584471
Category : Philosophy
Languages : en
Pages : 243

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This accompaniment to Taylor's documentary film of the same name, which premiered at the Toronto International Film Festival in 2008, is a peripatetic effort to bring philosophy to the streets. Taylor speaks with today's most influential thinkers in settings that give meaning and inspiration to the discussions. Most notable are Peter Singer's thoughts on ethics and consumption in the middle of busy Fifth Avenue, Michael Hardt's talk of revolution in a rowboat in Central Park, and Slavoj iek strolling through a garbage dump while criticizing environmentalism. There are also appearances by Cornel West, Avital Ronell, Kwame Anthony Appiah, Martha Nussbaum, and Judith Butler. Both the book and the film attempt to make philosophy approachable, and the majority of the discussions here do just that. Taylor, for better or worse, refrains from any overarching theme or commentary, although her interactions with these thinkers do go beyond mere interviews to productive philosophical debates. As in life, in the end it is the walks and the fruitful conversations that are important. Recommended for public libraries. [Look for the DVD review in a future issue.Ed.]Steven Chabot, Ontario Ministry of Labour, Toronto Copyright Reed Business Information, a division of Reed Elsevier Inc. All rights reserved.

Author: João Biehl
Publisher: Princeton University Press
ISBN: 0691157391
Category : Social Science
Languages : en
Pages : 454

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A people-centered approach to global health When People Come First critically assesses the expanding field of global health. It brings together an international and interdisciplinary group of scholars to address the medical, social, political, and economic dimensions of the global health enterprise through vivid case studies and bold conceptual work. The book demonstrates the crucial role of ethnography as an empirical lantern in global health, arguing for a more comprehensive, people-centered approach. Topics include the limits of technological quick fixes in disease control, the moral economy of global health science, the unexpected effects of massive treatment rollouts in resource-poor contexts, and how right-to-health activism coalesces with the increased influence of the pharmaceutical industry on health care. The contributors explore the altered landscapes left behind after programs scale up, break down, or move on. We learn that disease is really never just one thing, technology delivery does not equate with care, and biology and technology interact in ways we cannot always predict. The most effective solutions may well be found in people themselves, who consistently exceed the projections of experts and the medical-scientific, political, and humanitarian frameworks in which they are cast. When People Come First sets a new research agenda in global health and social theory and challenges us to rethink the relationships between care, rights, health, and economic futures.

Author: OECD
Publisher: OECD Publishing
ISBN: 9264091084
Category :
Languages : en
Pages : 157

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This report investigates how tax structures can best be designed to support GDP per capita growth.

Author: Frédéric Bourdier
Publisher: Centre for East and South-East Asian Studies Lund University
ISBN:
Category : AIDS (Disease)
Languages : en
Pages : 36

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