Le Concept De Validation Dans Lindustrie Pharmaceutique

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Labostat – Guide de validation des méthodes d'analyse

Author : FEINBERG
Publisher : Lavoisier
ISBN 13 : 2743064269
Total Pages : 386 pages
Book Rating : 4.7/5 (43 download)

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Book Synopsis Labostat – Guide de validation des méthodes d'analyse by : FEINBERG

Download or read book Labostat – Guide de validation des méthodes d'analyse written by FEINBERG and published by Lavoisier. This book was released on 2012-02-01 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: Unique en son genre dans sa conception et dans son contenu, Labo-Stat - Guide de validation des méthodes d'analyses présente une nouvelle stratégie de validation selon une démarche raisonnée fondée sur le profil d'exactitude. Les techniques statistiques adaptées y sont explicitées sous une forme didactique et les solutions possibles ainsi que les limites éventuelles de diverses normes existantes sont largement développées et illustrées d'exemples concrets directement exploitables. Les applications numériques, sous forme de feuilles de calcul modèles pour des tableurs et des petits scripts, sont téléchargeables en ligne. Complétée par les explications de cet ouvrage, elles permettent au non-statisticien d'accéder aisément à une interprétration graphique des résultats. Labo-Stat a été conçu pour pouvoir être facilement utilisé sur la paillasse du laboratoire et permettre à tout un chacun, responsable, ingénieur, chercheur, technicien ou étudiant, de s'approprier les techniques indispensables pour déboucher sur une conclusion claire et sans ambiguïté et mener la validation des méthodes dans un souci de contrôle des coûts.

ICH Quality Guidelines

Author : Andrew Teasdale
Publisher : John Wiley & Sons
ISBN 13 : 1118971132
Total Pages : 624 pages
Book Rating : 4.1/5 (189 download)

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Book Synopsis ICH Quality Guidelines by : Andrew Teasdale

Download or read book ICH Quality Guidelines written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2017-09-29 with total page 624 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

Detection of New Adverse Drug Reactions

Author : M. D. B. Stephens
Publisher : Stockton Press
ISBN 13 :
Total Pages : 566 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Detection of New Adverse Drug Reactions by : M. D. B. Stephens

Download or read book Detection of New Adverse Drug Reactions written by M. D. B. Stephens and published by Stockton Press. This book was released on 1998 with total page 566 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the drug information cycle within pharmaceutical companies and assesses existing methods of collection, storage and processing of adverse event data and outlines ways of improving the drug information cycle. It is the only reference covering the entire field of pharmacovigilance.

Innovate Bristol

Author : Sven Boermeester
Publisher :
ISBN 13 : 9781949677072
Total Pages : pages
Book Rating : 4.6/5 (77 download)

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Book Synopsis Innovate Bristol by : Sven Boermeester

Download or read book Innovate Bristol written by Sven Boermeester and published by . This book was released on 2019-12 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovate Bristol highlights and celebrates those companies and individuals that are actively working at building a better tomorrow for all. Innovation Ecosystems thrive through the involvement and support of companies and individuals from all industries, which is why the Innovate series not only focuses on the innovators but also those people whom the Innovation Ecosystem, would not be able to thrive without.

Single-Use Technology in Biopharmaceutical Manufacture

Author : Regine Eibl
Publisher : John Wiley & Sons
ISBN 13 : 1119477786
Total Pages : 367 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 367 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.

Handbook of Hygiene Control in the Food Industry

Author : H. L. M. Lelieveld
Publisher : Taylor & Francis US
ISBN 13 : 9781855739574
Total Pages : 752 pages
Book Rating : 4.7/5 (395 download)

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Book Synopsis Handbook of Hygiene Control in the Food Industry by : H. L. M. Lelieveld

Download or read book Handbook of Hygiene Control in the Food Industry written by H. L. M. Lelieveld and published by Taylor & Francis US. This book was released on 2005-10-30 with total page 752 pages. Available in PDF, EPUB and Kindle. Book excerpt: Complementing the highly successful Hygiene in food processing, this book reviews recent research on improving hygiene in food processing. Part 1 considers recent research on contamination risks such as biofilms and how they can be assessed. Part 2 reviews ways of improving hygienic design of both buildings and equipment, including clean room technology. The final part of the book discusses ways of improving hygiene practice and management.

Dictionary of Pharmaceutical Medicine

Author : Gerhard Nahler
Publisher : Springer Science & Business Media
ISBN 13 : 3709140161
Total Pages : 186 pages
Book Rating : 4.7/5 (91 download)

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Book Synopsis Dictionary of Pharmaceutical Medicine by : Gerhard Nahler

Download or read book Dictionary of Pharmaceutical Medicine written by Gerhard Nahler and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: This dictionary is aimed primarily at the beginners entering the new discipline of Pharmaceutical Medicine, an area comprising aspects of toxicology, pharmacology, pharmaceutics, epidemiology, statistics, drug regulatory and legal affairs, medicine and marketing. But also more experienced colleagues in departments engaged in clinical development as well as researchers and marketing experts in the pharmaceutical industry will find concise and up-to-date information. The book is completed by a list of a about 1000 abbreviations encountered in pharmaceutical medicine and a compilation of important addresses of national and international health authorities.

Drug Surveillance

Author : Zbigniew Bańkowski
Publisher : World Health Organization
ISBN 13 :
Total Pages : 214 pages
Book Rating : 4.:/5 (47 download)

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Book Synopsis Drug Surveillance by : Zbigniew Bańkowski

Download or read book Drug Surveillance written by Zbigniew Bańkowski and published by World Health Organization. This book was released on 1994 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt: Records the proceedings of an international conference convened to consider mechanisms for improving international cooperation in the surveillance of drug safety and the reporting of adverse reactions. Attended by close to 200 representatives of regulatory authorities and the pharmaceutical industry as well as clinical pharmacologists, the conference aimed to identify the strengths and weaknesses of existing mechanisms for international cooperation and to propose improvements for the future.

Developing Solid Oral Dosage Forms

Author : Yihong Qiu
Publisher : Academic Press
ISBN 13 : 008093272X
Total Pages : 976 pages
Book Rating : 4.0/5 (89 download)

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Book Synopsis Developing Solid Oral Dosage Forms by : Yihong Qiu

Download or read book Developing Solid Oral Dosage Forms written by Yihong Qiu and published by Academic Press. This book was released on 2009-03-10 with total page 976 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: - Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms - Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies - New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development - The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards - It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter - A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies

Biocontamination Control for Pharmaceuticals and Healthcare

Author : Tim Sandle
Publisher : Elsevier
ISBN 13 : 0443216010
Total Pages : 510 pages
Book Rating : 4.4/5 (432 download)

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Book Synopsis Biocontamination Control for Pharmaceuticals and Healthcare by : Tim Sandle

Download or read book Biocontamination Control for Pharmaceuticals and Healthcare written by Tim Sandle and published by Elsevier. This book was released on 2024-01-28 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covered many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation. Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy. - Includes the most current regulations - Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy - Offers practical guidance on building a complete biocontamination strategy

Regulating Pharmaceuticals In Europe: Striving For Efficiency, Equity And Quality

Author : Mossialos, Elias
Publisher : McGraw-Hill Education (UK)
ISBN 13 : 0335214657
Total Pages : 390 pages
Book Rating : 4.3/5 (352 download)

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Book Synopsis Regulating Pharmaceuticals In Europe: Striving For Efficiency, Equity And Quality by : Mossialos, Elias

Download or read book Regulating Pharmaceuticals In Europe: Striving For Efficiency, Equity And Quality written by Mossialos, Elias and published by McGraw-Hill Education (UK). This book was released on 2004-06-01 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This thoughtful and comprehensive book represents the best work I have seen on the current situation concerning medication policies in the EU. It is not just that this is a very up-to-date compendium of facts and data across a wide variety of domains that impact on pharmaceutical regulation. The book is also strong on analysis of those facts as well." Jerry Avorn, Harvard Medical School. "This book offers a comprehensive examination of approaches to manage pharmaceutical expenditures in Europe. It is a must-read for those who seek to understand and navigate the changing regulatory environment for medicines in the European Union." Bernie O'Brien, McMaster University, Canada. The rising cost of pharmaceutical expenditures in many European countries is of concern to governments required to make effective use of health care budgets. Taking a broad perspective that encompasses institutional, political and supranational aspects of pharmaceutical regulation, this book examines approaches used to manage pharmaceutical expenditure across Europe and what impact these strategies have had on efficiency, quality, equity and cost of pharmaceutical care.Regulating Pharmaceuticals in Europe is an important book for students of health policy, regulation and management, and for health managers and policy makers. The editors: Elias Mossialos is Brian Abel-Smith Professor of Health Policy at the London School of Economics and Political Science and a Research Director of the European Observatory on Health Systems and Policies. Monique Mrazek is a Health Economist (Europe and Central Asia region) for the World Bank and formerly a Research Officer in Health Economics for the European Observatory on Health Systems and Policies. Tom Walley is Professor of Clinical Pharmacology at the University of Liverpool and Director of the UK National Health Technology Assessment Programme. Contributors:Julia Abelson, Christa Altenstetter, Vittorio Berteleâ€™, Christine Bond, Marcel L. Bouvy, Colin Bradley, Steve Chapman, Anna Dixon, Michael Drummond, Pierre Durieux, Edzard Ernst, Armin Fidler, Eric Fortess, Richard Frank, Silvio Garattini, Leigh Hancher, Ebba Holme Hansen, Steve Hudson, Kees de Jonchere, Panos Kanavos, Sjoerd Kooiker, Jean-Marc Leder, Graham Lewis, Donald W. Light, Alistair McGuire, Elias Mossialos, Monique Mrazek, Maria Pia Orru', Govin Permanand, Guenka Petrova, Munir Pirmohamed, Dennis Ross-Degnan, Frans Rutten, Steven Soummerai, David Taylor, Sarah Thomson, Tom Walley.

The Colonial Life of Pharmaceuticals

Author : Laurence Monnais
Publisher : Cambridge University Press
ISBN 13 : 1108474667
Total Pages : 291 pages
Book Rating : 4.1/5 (84 download)

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Book Synopsis The Colonial Life of Pharmaceuticals by : Laurence Monnais

Download or read book The Colonial Life of Pharmaceuticals written by Laurence Monnais and published by Cambridge University Press. This book was released on 2019-08-22 with total page 291 pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovative examination of the early globalization of the pharmaceutical industry, arguing that colonialism was crucial to the worldwide diffusion of modern medicines.

Reformulation as a Strategy for Developing Healthier Food Products

Author : Vassilios Raikos
Publisher : Springer Nature
ISBN 13 : 3030236218
Total Pages : 321 pages
Book Rating : 4.0/5 (32 download)

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Book Synopsis Reformulation as a Strategy for Developing Healthier Food Products by : Vassilios Raikos

Download or read book Reformulation as a Strategy for Developing Healthier Food Products written by Vassilios Raikos and published by Springer Nature. This book was released on 2019-10-09 with total page 321 pages. Available in PDF, EPUB and Kindle. Book excerpt: This work introduces the concept of reformulation, a relatively new strategy to develop foods with beneficial properties. Food reformulation by definition is the act of re-designing an existing, often popular, processed food product with the primary objective of making it healthier. In recent years the concept of food reformulation has evolved significantly as additional benefits of re-designing food have become apparent. In addition to targeting specific food ingredients that are considered potentially harmful for human health, food reformulation can also be effectively used as a strategy to make foods more nutritious by introducing essential macro- /micro-nutrients or phytochemicals in the diet. Reformulating foods can also improve sustainability by introducing “waste” (and underutilized) ingredients into the food chain. In light of these developments, reformulating existing foods is now considered a realistic and attractive opportunity to provide healthy, nutritious, and sustainable food choices to the consumers and likewise improve public health. Indeed reformulation has now become essential in many cases for redressing the health properties of foods that are popularly consumed and significantly affecting public health. This edited volume covers aspects of food reformulation from various angles, exploring the role of the food industry, academia, and consumers in developing new products. Some of the major themes contributors address include methods of reformulating food products for health, improving the nutritional composition of foods, and challenges to the food industry, including regulation as well as consumer perception of new products. The book presents several case studies to clarify these objectives and illustrate the difficulties encountered in the process of developing a reformulated product. Chapters from experts in the field identify emerging and future trends in food product development, and highlight ways in which these efforts will help with increasing food security, improving nutrition and health, and promoting sustainable production. The editors have designed the book to be useful for both industry professionals and the research community. This interdisciplinary approach incorporates a wide spectrum of food sciences (including composition, engineering, and chemistry) as well as nutrition and public health. Food and nutrition professionals, policy makers, health care and social scientists, and graduate students will also find the information relevant.

Aanwinsten van de Centrale Bibliotheek (Queteletfonds)

Author : Bibliothèque centrale (Fonds Quetelet)
Publisher :
ISBN 13 :
Total Pages : 984 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Aanwinsten van de Centrale Bibliotheek (Queteletfonds) by : Bibliothèque centrale (Fonds Quetelet)

Download or read book Aanwinsten van de Centrale Bibliotheek (Queteletfonds) written by Bibliothèque centrale (Fonds Quetelet) and published by . This book was released on 1985 with total page 984 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Understanding Obstacles to Peace

Author : Mwesiga Laurent Baregu
Publisher : IDRC
ISBN 13 : 9970250361
Total Pages : 383 pages
Book Rating : 4.9/5 (72 download)

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Book Synopsis Understanding Obstacles to Peace by : Mwesiga Laurent Baregu

Download or read book Understanding Obstacles to Peace written by Mwesiga Laurent Baregu and published by IDRC. This book was released on 2011 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes and analyzes protracted conflicts in the Great Lakes Region of Africa. In doing so, it emphasizes obstacles to peace rather than root causes of conflict. Case studies are presented from Burundi, the Democratic Republic of the Congo, Northern Kenya, Northern Uganda, Southern Sudan, and Zanzibar. Amongst other conclusions, the book shows that, to settle or transform protracted conflicts, distinction must be made between strategic and nonstrategic actors: the former must be able to prevail upon the latter in the negotiation and implementation of peace agreements. The theme and collection of the research presented in this book is unique in the literature. The case studies all employ methods of othick description, o process tracing (following particular actors and their interests), and in-depth personal interviews. The book will be of interest to academics, researchers, undergraduate and post-graduate students, and professionals in conflict theory, analysis and resolution, African and development studies, political science and international affairs, as well as to mediators, negotiators, and facilitators in conflict resolution

Pharmaceutical Isolators

Author : Brian Midcalf
Publisher : Pharmaceutical Press
ISBN 13 : 9780853695738
Total Pages : 292 pages
Book Rating : 4.6/5 (957 download)

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Book Synopsis Pharmaceutical Isolators by : Brian Midcalf

Download or read book Pharmaceutical Isolators written by Brian Midcalf and published by Pharmaceutical Press. This book was released on 2004 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: This work considers the basic concepts, definitions, and standards necessary in the design, construction, commissioning, maintenance, and use of pharmaceutical isolators.

Continuous Biomanufacturing

Author : Ganapathy Subramanian
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.