Le laboratoire de contrôle dans l'industrie pharmaceutique vers l'agrément FDA

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Publisher :
ISBN 13 :
Total Pages : 30 pages
Book Rating : 4.:/5 (758 download)

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Book Synopsis Le laboratoire de contrôle dans l'industrie pharmaceutique vers l'agrément FDA by : Nathalie Sicot

Download or read book Le laboratoire de contrôle dans l'industrie pharmaceutique vers l'agrément FDA written by Nathalie Sicot and published by . This book was released on 1995 with total page 30 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Obtention de l'agrément FDA [Food and Drug Administration]

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Publisher :
ISBN 13 :
Total Pages : 384 pages
Book Rating : 4.:/5 (494 download)

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Book Synopsis Obtention de l'agrément FDA [Food and Drug Administration] by : Johanna Aimé

Download or read book Obtention de l'agrément FDA [Food and Drug Administration] written by Johanna Aimé and published by . This book was released on 2008 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Mise en conformité FDA d'un site de production pharmaceutique

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Publisher :
ISBN 13 :
Total Pages : 186 pages
Book Rating : 4.:/5 (758 download)

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Book Synopsis Mise en conformité FDA d'un site de production pharmaceutique by : Ornella Sylviane Siewe Mpougom

Download or read book Mise en conformité FDA d'un site de production pharmaceutique written by Ornella Sylviane Siewe Mpougom and published by . This book was released on 2011 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: Les entreprises pharmaceutiques ont depuis toujours oeuvré pour la santé des patients à travers le monde. Les produits qu'elles fabriquent sont soumis à des exigences règlementaires différentes en fonction des marchés et sans cesse en évolution. Le marché du médicament est régi aux Etats-Unis par la Food and Drug Administration (FDA). Les entreprises désireuses d'exporter leurs produits aux USA sont ainsi soumises aux exigences de la FDA et doivent traverser un certain nombre d'étapes avant l'obtention de l'autorisation de commercialisation, parmi lesquelles l'étape de mise en conformité règlementaire. Après une présentation des référentiels règlementaires à appliquer dans l'industrie pharmaceutique, ce mémoire vous présente les différentes démarches à suivre lorsqu'une entreprise pharmaceutique désire fabriquer des médicaments pour le marché américain : de la constitution du dossier de demande d'autorisation à l'obtention de l'agrément. L'exemple d'un projet de mise en conformité règlementaire est également donné à la fin de ce mémoire.

Pharmacopolitics

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Publisher : Chemical Heritage Foundation
ISBN 13 : 9780807828441
Total Pages : 232 pages
Book Rating : 4.8/5 (284 download)

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Book Synopsis Pharmacopolitics by : Arthur A. Daemmrich

Download or read book Pharmacopolitics written by Arthur A. Daemmrich and published by Chemical Heritage Foundation. This book was released on 2004 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacopolitics: Drug Regulation in the United States and Germany

The Body Economic

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Publisher : Basic Books
ISBN 13 : 0465063977
Total Pages : 242 pages
Book Rating : 4.4/5 (65 download)

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Book Synopsis The Body Economic by : David Stuckler

Download or read book The Body Economic written by David Stuckler and published by Basic Books. This book was released on 2013-05-21 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: Politicians have talked endlessly about the seismic economic and social impacts of the recent financial crisis, but many continue to ignore its disastrous effects on human health—and have even exacerbated them, by adopting harsh austerity measures and cutting key social programs at a time when constituents need them most. The result, as pioneering public health experts David Stuckler and Sanjay Basu reveal in this provocative book, is that many countries have turned their recessions into veritable epidemics, ruining or extinguishing thousands of lives in a misguided attempt to balance budgets and shore up financial markets. Yet sound alternative policies could instead help improve economies and protect public health at the same time. In The Body Economic, Stuckler and Basu mine data from around the globe and throughout history to show how government policy becomes a matter of life and death during financial crises. In a series of historical case studies stretching from 1930s America, to Russia and Indonesia in the 1990s, to present-day Greece, Britain, Spain, and the U.S., Stuckler and Basu reveal that governmental mismanagement of financial strife has resulted in a grim array of human tragedies, from suicides to HIV infections. Yet people can and do stay healthy, and even get healthier, during downturns. During the Great Depression, U.S. deaths actually plummeted, and today Iceland, Norway, and Japan are happier and healthier than ever, proof that public wellbeing need not be sacrificed for fiscal health. Full of shocking and counterintuitive revelations and bold policy recommendations, The Body Economic offers an alternative to austerity—one that will prevent widespread suffering, both now and in the future.

Single-Use Technology in Biopharmaceutical Manufacture

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Publisher : John Wiley & Sons
ISBN 13 : 1119477786
Total Pages : 368 pages
Book Rating : 4.1/5 (194 download)

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Book Synopsis Single-Use Technology in Biopharmaceutical Manufacture by : Regine Eibl

Download or read book Single-Use Technology in Biopharmaceutical Manufacture written by Regine Eibl and published by John Wiley & Sons. This book was released on 2019-07-18 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.

Continuous Biomanufacturing

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Publisher : John Wiley & Sons
ISBN 13 : 3527340637
Total Pages : 628 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Continuous Biomanufacturing by : Ganapathy Subramanian

Download or read book Continuous Biomanufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2017-12-26 with total page 628 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.

New Frontiers in the Economics of Innovation and New Technology

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Publisher : Edward Elgar Publishing
ISBN 13 : 1845427920
Total Pages : 495 pages
Book Rating : 4.8/5 (454 download)

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Book Synopsis New Frontiers in the Economics of Innovation and New Technology by : Cristiano Antonelli

Download or read book New Frontiers in the Economics of Innovation and New Technology written by Cristiano Antonelli and published by Edward Elgar Publishing. This book was released on 2006-01-01 with total page 495 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Festschrift explores the truly exceptional breadth and depth of Paul David s work, focusing upon his contributions to the topics of path dependence, the economics of knowledge, and the diffusion of technology. The book consists of 15 papers plus an introduction by the editors and an entertaining postscript by Dominique Foray. . . For economic historians, the papers on path dependence assembled in this book, and particularly the conceptual paper by Antonelli, should be essential reading. Nikolaus Wolf, Economic History Review Recent research on the economics of innovation has acknowledged the importance of path dependence and networks in the evolution of economies and the diffusion of new techniques, products, and processes. These are topics pioneered by Paul A. David, one of the world s leading scholars in the economics of innovation. This outstanding collection provides a fitting tribute to the diversity and depth of Paul David s contributions. The papers included range from simulation models of the evolution of market structure in the presence of innovation, through historical investigations of knowledge networks and empirical analysis of contemporary networks, to the analysis of the diffusion of innovations using simulation and analytic models and of the diffusion of knowledge using patent data. With an emphasis on simulation models, data analysis, and historical evidence, this book will be required reading for researchers in innovation economics and regional development as well as economists, sociologists, and historians of innovation and intellectual property.

Cancer Wars

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ISBN 13 :
Total Pages : 372 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Cancer Wars by : Robert Proctor

Download or read book Cancer Wars written by Robert Proctor and published by . This book was released on 1995 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by a highly regarded historian of science, this meticulouly researched, eminently fair, and very provocative book attempts to answer the question: Why, given all the time and money spent on cancer research, can't we get consistent answers to the most fundamental questions about prevention and treatment?

Ethics and the Pharmaceutical Industry

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Publisher : Cambridge University Press
ISBN 13 : 1139448579
Total Pages : 528 pages
Book Rating : 4.1/5 (394 download)

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Book Synopsis Ethics and the Pharmaceutical Industry by : Michael A. Santoro

Download or read book Ethics and the Pharmaceutical Industry written by Michael A. Santoro and published by Cambridge University Press. This book was released on 2005-10-31 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite the pharmaceutical industry's notable contributions to human progress, including the development of miracle drugs for treating cancer, AIDS, and heart disease, there is a growing tension between the industry and the public. Government officials and social critics have questioned whether the multibillion-dollar industry is fulfilling its social responsibilities. This doubt has been fueled by the national debate over drug pricing and affordable healthcare, and internationally by the battles against epidemic diseases, such as AIDS, in the developing world. Debates are raging over how the industry can and should be expected to act. The contributions in this book by leading figures in industry, government, NGOs, the medical community, and academia discuss and propose solutions to the ethical dilemmas of drug industry behavior. They examine such aspects as the role of intellectual property rights and patent protection, the moral and economic requisites of research and clinical trials, drug pricing, and marketing.

The Patient Will See You Now

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Publisher : Basic Books
ISBN 13 : 0465094473
Total Pages : 386 pages
Book Rating : 4.4/5 (65 download)

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Book Synopsis The Patient Will See You Now by : Eric Topol

Download or read book The Patient Will See You Now written by Eric Topol and published by Basic Books. This book was released on 2016-10-25 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: The essential guide by one of America's leading doctors to how digital technology enables all of us to take charge of our health A trip to the doctor is almost a guarantee of misery. You'll make an appointment months in advance. You'll probably wait for several hours until you hear "the doctor will see you now"-but only for fifteen minutes! Then you'll wait even longer for lab tests, the results of which you'll likely never see, unless they indicate further (and more invasive) tests, most of which will probably prove unnecessary (much like physicals themselves). And your bill will be astronomical. In The Patient Will See You Now, Eric Topol, one of the nation's top physicians, shows why medicine does not have to be that way. Instead, you could use your smartphone to get rapid test results from one drop of blood, monitor your vital signs both day and night, and use an artificially intelligent algorithm to receive a diagnosis without having to see a doctor, all at a small fraction of the cost imposed by our modern healthcare system. The change is powered by what Topol calls medicine's "Gutenberg moment." Much as the printing press took learning out of the hands of a priestly class, the mobile internet is doing the same for medicine, giving us unprecedented control over our healthcare. With smartphones in hand, we are no longer beholden to an impersonal and paternalistic system in which "doctor knows best." Medicine has been digitized, Topol argues; now it will be democratized. Computers will replace physicians for many diagnostic tasks, citizen science will give rise to citizen medicine, and enormous data sets will give us new means to attack conditions that have long been incurable. Massive, open, online medicine, where diagnostics are done by Facebook-like comparisons of medical profiles, will enable real-time, real-world research on massive populations. There's no doubt the path forward will be complicated: the medical establishment will resist these changes, and digitized medicine inevitably raises serious issues surrounding privacy. Nevertheless, the result-better, cheaper, and more human health care-will be worth it. Provocative and engrossing, The Patient Will See You Now is essential reading for anyone who thinks they deserve better health care. That is, for all of us.

Cambridge Handbook of Engineering Education Research

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Publisher : Cambridge University Press
ISBN 13 : 1107785855
Total Pages : 1124 pages
Book Rating : 4.1/5 (77 download)

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Book Synopsis Cambridge Handbook of Engineering Education Research by : Aditya Johri

Download or read book Cambridge Handbook of Engineering Education Research written by Aditya Johri and published by Cambridge University Press. This book was released on 2014-02-10 with total page 1124 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Cambridge Handbook of Engineering Education Research is the critical reference source for the growing field of engineering education research, featuring the work of world luminaries writing to define and inform this emerging field. The Handbook draws extensively on contemporary research in the learning sciences, examining how technology affects learners and learning environments, and the role of social context in learning. Since a landmark issue of the Journal of Engineering Education (2005), in which senior scholars argued for a stronger theoretical and empirically driven agenda, engineering education has quickly emerged as a research-driven field increasing in both theoretical and empirical work drawing on many social science disciplines, disciplinary engineering knowledge, and computing. The Handbook is based on the research agenda from a series of interdisciplinary colloquia funded by the US National Science Foundation and published in the Journal of Engineering Education in October 2006.

Engineering

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Publisher : UNESCO
ISBN 13 : 9231041568
Total Pages : 392 pages
Book Rating : 4.2/5 (31 download)

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Book Synopsis Engineering by : Unesco

Download or read book Engineering written by Unesco and published by UNESCO. This book was released on 2010-01-01 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report reviews engineering's importance to human, economic, social and cultural development and in addressing the UN Millennium Development Goals. Engineering tends to be viewed as a national issue, but engineering knowledge, companies, conferences and journals, all demonstrate that it is as international as science. The report reviews the role of engineering in development, and covers issues including poverty reduction, sustainable development, climate change mitigation and adaptation. It presents the various fields of engineering around the world and is intended to identify issues and challenges facing engineering, promote better understanding of engineering and its role, and highlight ways of making engineering more attractive to young people, especially women.--Publisher's description.

Engineering for Sustainable Development

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Publisher : UNESCO Publishing
ISBN 13 : 9231004379
Total Pages : 183 pages
Book Rating : 4.2/5 (31 download)

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Book Synopsis Engineering for Sustainable Development by : International Centre for Engineering Education

Download or read book Engineering for Sustainable Development written by International Centre for Engineering Education and published by UNESCO Publishing. This book was released on 2021-03-02 with total page 183 pages. Available in PDF, EPUB and Kindle. Book excerpt: The report highlights the crucial role of engineering in achieving each of the 17 SDGs. It shows how equal opportunities for all is key to ensuring an inclusive and gender balanced profession that can better respond to the shortage of engineers for implementing the SDGs. It provides a snapshot of the engineering innovations that are shaping our world, especially emerging technologies such as big data and AI, which are crucial for addressing the pressing challenges facing humankind and the planet. It analyses the transformation of engineering education and capacity-building at the dawn of the Fourth Industrial Revolution that will enable engineers to tackle the challenges ahead. It highlights the global effort needed to address the specific regional disparities, while summarizing the trends of engineering across the different regions of the world.

Molecular Mechanisms of Hormone Action

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Publisher :
ISBN 13 :
Total Pages : 224 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Molecular Mechanisms of Hormone Action by : Gesellschaft für Biologische Chemie. Colloquium

Download or read book Molecular Mechanisms of Hormone Action written by Gesellschaft für Biologische Chemie. Colloquium and published by . This book was released on 1989 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Glaucoma

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Publisher : Understand the Disease and Its
ISBN 13 : 9782923830209
Total Pages : 144 pages
Book Rating : 4.8/5 (32 download)

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Book Synopsis Glaucoma by : Pierre Blondeau

Download or read book Glaucoma written by Pierre Blondeau and published by Understand the Disease and Its. This book was released on 2013-10 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt: About 400,000 Canadians suffer from glaucoma. In fact, this chronic eye disease affects 1 percent to 3 percent of the population of the Western world age 40 and over, and its incidence increases with age-reaching 10 percent in people over 80. Glaucoma is an extremely insidious disease. It can destroy the functional capacity of the eyes irreversibly and without warning. Screening is thus a major issue in the fight against glaucoma, especially as there are effective treatments that can prevent or slow progression of the disease. Written in simple and clear language by doctors specializing in eye disorders, this book covers all aspects of the disease and provides important information for those who have glaucoma and the people close to them: The different forms and symptoms of glaucoma Known causes and risk factors Diagnostic tests Prevention Drug therapies, laser treatments and surgical procedures Daily living with glaucoma Treatments of the future 25 most frequently asked questions (FAQs) about glaucoma Useful addresses

CIHR Best Practices for Protecting Privacy in Health Research

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Publisher :
ISBN 13 : 9786624105642
Total Pages : pages
Book Rating : 4.1/5 (56 download)

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Book Synopsis CIHR Best Practices for Protecting Privacy in Health Research by :

Download or read book CIHR Best Practices for Protecting Privacy in Health Research written by and published by . This book was released on 2005 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: