Labostat – Guide de validation des méthodes d'analyse

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Author :
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

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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

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Author :
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

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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.

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

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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 Bertele’, 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.

Dictionary of Pharmaceutical Medicine

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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

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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.

Handbook of Hygiene Control in the Food Industry

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Author :
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.

Single-Use Technology in Biopharmaceutical Manufacture

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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.

Biocontamination Control for Pharmaceuticals and Healthcare

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Author :
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

Developing Solid Oral Dosage Forms

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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

The Colonial Life of Pharmaceuticals

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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.

Aanwinsten van de Centrale Bibliotheek (Queteletfonds)

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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:

Chemical Analysis

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Publisher : John Wiley & Sons
ISBN 13 : 1118681878
Total Pages : 494 pages
Book Rating : 4.1/5 (186 download)

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Book Synopsis Chemical Analysis by : Francis Rouessac

Download or read book Chemical Analysis written by Francis Rouessac and published by John Wiley & Sons. This book was released on 2013-05-06 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated, Chemical Analysis: Second Edition is an essential introduction to a wide range of analytical techniques and instruments. Assuming little in the way of prior knowledge, this text carefully guides the reader through the more widely used and important techniques, whilst avoiding excessive technical detail. Provides a thorough introduction to a wide range of the most important and widely used instrumental techniques Maintains a careful balance between depth and breadth of coverage Includes examples, problems and their solutions Includes coverage of latest developments including supercritical fluid chromatography and capillary electrophoresis

Pharmaceutical Isolators

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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.

Empirical Methods for Exploiting Parallel Texts

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Publisher : MIT Press
ISBN 13 : 9780262133807
Total Pages : 224 pages
Book Rating : 4.1/5 (338 download)

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Book Synopsis Empirical Methods for Exploiting Parallel Texts by : I. Dan Melamed

Download or read book Empirical Methods for Exploiting Parallel Texts written by I. Dan Melamed and published by MIT Press. This book was released on 2001 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book lays out the theory and the practical techniques for discovering and applying translational equivalence at the lexical level. Parallel texts (bitexts) are a goldmine of linguistic knowledge, because the translation of a text into another language can be viewed as a detailed annotation of what that text means. Knowledge about translational equivalence, which can be gleaned from bitexts, is of central importance for applications such as manual and machine translation, cross-language information retrieval, and corpus linguistics. The availability of bitexts has increased dramatically since the advent of the Web, making their study an exciting new area of research in natural language processing. This book lays out the theory and the practical techniques for discovering and applying translational equivalence at the lexical level. It is a start-to-finish guide to designing and evaluating many translingual applications.

3D Printing of Pharmaceuticals

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Author :
Publisher : Springer
ISBN 13 : 3319907557
Total Pages : 246 pages
Book Rating : 4.3/5 (199 download)

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Book Synopsis 3D Printing of Pharmaceuticals by : Abdul W. Basit

Download or read book 3D Printing of Pharmaceuticals written by Abdul W. Basit and published by Springer. This book was released on 2018-08-06 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: 3D printing is forecast to revolutionise the pharmaceutical sector, changing the face of medicine development, manufacture and use. Potential applications range from pre-clinical drug development and dosage form design through to the fabrication of functionalised implants and regenerative medicine. Within clinical pharmacy practice, printing technologies may finally lead to the concept of personalised medicines becoming a reality. This volume aims to be the definitive resource for anyone thinking of developing or using 3D printing technologies in the pharmaceutical sector, with a strong focus on the translation of printing technologies to a clinical setting. This text brings together leading experts to provide extensive information on an array of 3D printing techniques, reviewing the current printing technologies in the pharmaceutical manufacturing supply chain, in particular, highlighting the state-of-the-art applications in medicine and discussing modern drug product manufacture from a regulatory perspective. This book is a highly valuable resource for a range of demographics, including academic researchers and the pharmaceutical industry, providing a comprehensive inventory detailing the current and future applications of 3D printing in pharmaceuticals. Abdul W. Basit is Professor of Pharmaceutics at the UCL School of Pharmacy, University College London. Abdul’s research sits at the interface between pharmaceutical science and gastroenterology, forging links between basic science and clinical outcomes. He leads a large and multidisciplinary research group, and the goal of his work is to further the understanding of gastrointestinal physiology by fundamental research. So far, this knowledge has been translated into the design of new technologies and improved disease treatments, many of which are currently in late-stage clinical trials. He has published over 350 papers, book chapters and abstracts and delivered more than 250 invited research presentations. Abdul is also a serial entrepreneur and has filed 25 patents and founded 3 pharmaceutical companies (Kuecept, Intract Pharma, FabRx). Abdul is a frequent speaker at international conferences, serves as a consultant to many pharmaceutical companies and is on the advisory boards of scientific journals, healthcare organisations and charitable bodies. He is the European Editor of the International Journal of Pharmaceutics. Abdul was the recipient of the Young Investigator Award in Pharmaceutics and Pharmaceutical Technology from the American Association of Pharmaceutical Scientists (AAPS) and is the only non-North American scientist to receive this award. He was also the recipient of the Academy of Pharmaceutical Sciences (APS) award. Simon Gaisford holds a Chair in Pharmaceutics and is Head of the Department of Pharmaceutics at the UCL School of Pharmacy, University College London. He has published 110 papers, 8 book chapters and 4 authored books. His research is focused on novel technologies for manufacturing medicines, particularly using ink-jet printing and 3D printing, and he is an expert in the physico-chemical characterisation of compounds and formulations with thermal methods and calorimetry.