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Therapeutic Risk Management of Medicines

Therapeutic Risk Management of Medicines
A Book

by Stephen J. Mayall,Anjan Swapu Banerjee

  • Publisher : Elsevier
  • Release : 2014-04-16
  • Pages : 448
  • ISBN : 1908818271
  • Language : En, Es, Fr & De
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Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders. A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved rapidly over the past decade. Risk management plans (RMPs) are mandatory for new medicinal products in the EU and a Risk Evaluation and Mitigation Strategy (REMS) is needed for certain drugs in the US. This book is an easy-to-read resource that complements current regulatory guidance, by exploring key areas and practical implications in greater detail. It is structured into chapters encompassing a background to therapeutic risk management, strategies for developing RMPs, implementation of RMPs, and the continuing evolution of the risk management field.The topic is of critical importance not only to the pharmaceutical and biotechnology industries, but also regulators and healthcare policymakers.Some chapters feature contributions from selected industry experts. An up-to-date practical guide on conceiving, designing, and implementing global therapeutic risk management plans for medicines A number of useful frameworks are presented which add impact to RMPs (Risk Management Plans), together with regional specific information (European Union, United States, and Japan) A comprehensive guide for performing risk management more effectively throughout a product’s life-cycle

Therapeutic Risk

Therapeutic Risk
Perception, Measurement, Management

by William Howard Wallace Inman,D. M. Burley

  • Publisher : John Wiley & Sons
  • Release : 1988
  • Pages : 103
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Today's therapeutic drugs are capable of beneficial results but can also cause great harm, especially if administered to the wrong patient in the wrong dosage. This book is devoted to the perception, measurement and management of therapeutic risk, and outlines the results of a conference on the subject held in Brighton, Sussex in June 1987 - a joint enterprise between the Trust for Education and Research in Therapeutics, London, and the Drug Safety Research Trust, Southampton. It examines the results of dispensing drugs, the rarity or seriousness of attendant risks involved and the manner in which therapeutic drugs can be measured and controlled.

The Perception and Management of Therapeutic Risk

The Perception and Management of Therapeutic Risk
A Book

by Paul Slovic,Centre for Medicines Research

  • Publisher : Unknown Publisher
  • Release : 1989
  • Pages : 32
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Therapeutic Protein Drug Products

Therapeutic Protein Drug Products
Practical Approaches to formulation in the Laboratory, Manufacturing, and the Clinic

by Brian K Meyer

  • Publisher : Elsevier
  • Release : 2012-01-02
  • Pages : 200
  • ISBN : 1908818107
  • Language : En, Es, Fr & De
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Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed. Provides a list and description of commercially available therapeutic drug products and their formulations A comprehensive and practical overview of protein formulation in the laboratory, manufacturing, and the clinic Discusses recent topics including high protein concentration, phase separation, opalescence, and subvisible particles

Guidelines for Off-Label Drugs : Concept and Good Clinical Practice

Guidelines for Off-Label Drugs : Concept and Good Clinical Practice
A Book

by Ph. Malik Qasem Ozaybi

  • Publisher : Ph. Malik Qasem Ozaybi
  • Release : 2021-05-12
  • Pages : 134
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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This edition of the book encompasses the off label(unapproved) indications and uses of 191 drugs with last update also comparison with FDA approved indications. Also give you Information about research and how to make an excellent research with discussion and compare between primary studies and secondary studies with advantages and disadvantages. In this book we will talk about the concept of strength of Recommendations and strength of Evidence with age Group to make decisions on the use of certain drugs that have off label with beautiful color for the figures and tables. This is really an interesting book for medical professionals with last update 2021. “Off-Label “ means the Medication is being used in manner not specified in the , FDA’s approved packaging label or insert. Some medications used as off-label only .Fast review for most medical terminology used and TDM for specific drugs with their Therapeutic Range. This book show you in details about resources as website and application. Policies and administration for off label with their form used in Hospitals and PHC. Drugs index and kay considerations. We will discuss many topics that related to off-Label with their details including safety of use medicines with pregnant and categories of pregnancy . The only guidelines available for this type of medications according to its contents.

Human Drug Metabolism

Human Drug Metabolism
A Book

by Michael D. Coleman

  • Publisher : John Wiley & Sons
  • Release : 2020-02-19
  • Pages : 680
  • ISBN : 1119458560
  • Language : En, Es, Fr & De
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Provides a timely update to a key textbook on human drug metabolism The third edition of this comprehensive book covers basic concepts of teaching drug metabolism, starting from extreme clinical consequences to systems and mechanisms and toxicity. It provides an invaluable introduction to the core areas of pharmacology and examines recent progress and advances in this fast moving field and its clinical impact. Human Drug Metabolism, 3rd Edition begins by covering basic concepts such as clearance and bioavailability, and looks at the evolution of biotransformation, and how drugs fit into this carefully managed biological environment. More information on how cytochrome P450s function and how they are modulated at the sub-cellular level is offered in this new edition. The book also introduces helpful concepts for those struggling with the relationship of pharmacology to physiology, as well as the inhibition of biotransformational activity. Recent advances in knowledge of a number of other metabolizing systems are covered, including glucuronidation and sulphation, along with the main drug transporters. Also, themes from the last edition are developed in an attempt to chart the progress of personalized medicine from concepts towards practical inclusion in routine therapeutics. The last chapter focuses on our understanding of how and why drugs injure us, both in predictable and unpredictable ways. Appendix A highlights some practical approaches employed in both drug metabolism research and drug discovery, whilst Appendix B outlines the metabolism of some drugs of abuse. Appendix C advises on formal examination preparation and Appendix D lists some substrates, inducers and inhibitors of the major human cytochrome P450s. Fully updated to reflect advances in the scientific field of drug metabolism and its clinical impact Reflects refinements in the author's teaching method, particularly with respect to helping students understand biological systems and how they operate Illustrates the growing relationship between drug metabolism and personalized medicine Includes recent developments in drug discovery, genomics, and stem cell technologies Human Drug Metabolism, 3rd Edition is an excellent book for advanced undergraduate and graduate students in molecular biology, biochemistry, pharmacology, pharmacy, and toxicology. It will also appeal to professionals interested in an introduction to this field, or who want to learn more about these bench-to-bedside topics to apply it to their practice.

The Pharmacist at the Crossroads of New Health Risks - an Indispensable Partner for Their Management

The Pharmacist at the Crossroads of New Health Risks - an Indispensable Partner for Their Management
Proceedings, Strasbourg, 20-22 October 1999

by Council of Europe

  • Publisher : Council of Europe
  • Release : 2000-01-01
  • Pages : 222
  • ISBN : 9789287144041
  • Language : En, Es, Fr & De
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This publication contains the speeches and conclusions of a seminar held in October 1999, which looked at the role of the pharmacist as a co-guarantor of health security. The first theme was health challenges of the 21st Century, which included the safety of new therapies, the pharmacists role in risk management and the problems of the counterfeiting of drugs. The second theme concerned the challenges of the new technologies both the dangers of selling drugs over the internet and the opportunities of increased networking professional information. The final theme looked at the risks of the new technologies and the ways that the pharmacist could add value. The conclusions of the seminar will serve as the framework for a Resolution of the Council of Europe's Committee of Ministers.

Communicating about Risks and Safe Use of Medicines

Communicating about Risks and Safe Use of Medicines
Real Life and Applied Research

by Priya Bahri

  • Publisher : Springer Nature
  • Release : 2020-06-17
  • Pages : 504
  • ISBN : 9811530130
  • Language : En, Es, Fr & De
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At the core of this book lies the question how to approach medicines, risks and communication as a researcher - or anybody planning and evaluating a communication intervention, or wanting to understand communication events in private and the media. With a view to tackle current shortcomings of communication systems and processes for improved implementation, patient satisfaction and health outcomes, a multilayered approach is presented. This combines multiple data types and methods to obtain a wider and deeper understanding of the major parties and their interactions, as well as the healthcare, social and political contexts of information flows, how they interfere and which impact they have. Illustrated with real life experiences of safety concerns with medicines, worldwide active experts discuss the methods and contributions their disciplines can offer. With considerations on terminologies, tabulated overviews on communication types and outcomes, a patient-centred vision and plain language for non-medical readers, the book creates a platform for multidisciplinary collaborations amongst researchers as well as practitioners from communications, healthcare, the social sciences and pharmacovigilance. Importantly, it advocates for an active role of patients and highlights the achievements and aspirations of patient organisations. Finally, the book suggests establishing an inclusive discipline of humanities and epidemiology of medicinal product risk communication to realise full research potential. The authors are driven by the curiosity for communication as the most human behaviour, and as good health is amongst the basic human needs, medicinal product risk communication is an exciting research field of high global relevance.

Therapeutic Antibody Engineering

Therapeutic Antibody Engineering
Current and Future Advances Driving the Strongest Growth Area in the Pharmaceutical Industry

by William R Strohl,Lila M Strohl

  • Publisher : Elsevier
  • Release : 2012-10-16
  • Pages : 696
  • ISBN : 1908818093
  • Language : En, Es, Fr & De
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The field of antibody engineering has become a vital and integral part of making new, improved next generation therapeutic monoclonal antibodies, of which there are currently more than 300 in clinical trials across several therapeutic areas. Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on future candidates. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental technologies used in their production. Following chapters cover a number of specific issues relating to different aspects of antibody engineering, including variable chain engineering, targets and mechanisms of action, classes of antibody and the use of antibody fragments, among many other topics. The last part of the book examines development issues, the interaction of human IgGs with non-human systems, and cell line development, before a conclusion looking at future issues affecting the field of therapeutic antibody engineering. Goes beyond the standard engineering issues covered by most books and delves into structure-function relationships Integration of knowledge across all areas of antibody engineering, development, and marketing Discusses how current and future genetic engineering of cell lines will pave the way for much higher productivity

Gene therapy

Gene therapy
Potential Applications of Nanotechnology

by Surendra Nimesh

  • Publisher : Elsevier
  • Release : 2013-10-31
  • Pages : 380
  • ISBN : 1908818646
  • Language : En, Es, Fr & De
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Gene therapy is emerging as a new class of therapeutics for the treatment of inherited and acquired diseases. However, poor cellular uptake and instability of DNA in the physiological milieu limits its therapeutic potential, hence a vector which can protect and efficiently transport DNA to the target cells must be developed. Nanotechnology-based non-viral vectors have been proposed as potential candidates. Various polymeric nanoparticles have been shown to be suitable, with high cellular uptake efficiencies and reduced cytotoxicity. These delivery vectors form condensed complexes with DNA which result in shielding against enzymatic degradation and enhanced cellular targeting. Advantages including easy manipulatibility, high stability, low cost and high payload, mean that nanoparticles from various polymers have been exploited. Gene therapy gives a systematic account of the many aspects of nanotechnology mediated gene therapy, from the preparation of nanoparticles to physicochemical characterization, and follows with applications in in vitro and in vivo models. This book emphasizes the various aspects of nanotechnology-based gene therapy, with initial chapters detailing the tools and techniques available for preparation and in vitro and in vivo characterization of nanoparticles. Later chapters provide exhaustive details on polymeric systems employed for gene therapy. Provides an overview of nanotechnology applications in gene therapy, from preparation of nanoparticles to in vitro and in vivo studies Details the tools and techniques available for preparation, characterization and in vitro and in vivo study of nanoparticles Details the limitations of nanoparticle-mediated gene therapy and proposes ways in which they may be overcome

Nanoparticulate Drug Delivery

Nanoparticulate Drug Delivery
Perspectives on the Transition from Laboratory to Market

by Vandana Patravale,Prajakta Dandekar,Ratnesh Jain

  • Publisher : Elsevier
  • Release : 2012-10-31
  • Pages : 244
  • ISBN : 1908818190
  • Language : En, Es, Fr & De
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Nanotechnology-based therapeutics, operating at scales of billionths of a metre, have great potential for future expansion in altering the scale and methods of drug delivery. The availability of these novel formulations to once-inaccessible areas of the body has greatly expanded the therapeutic window of existing drug molecules. Nanoparticulate drug delivery highlights and examines the transition of nanoparticulate drug delivery systems from the laboratory into a commercially viable sector. The first chapters of the book provide an overview of the use and characterization of nanoparticulate systems as drug carriers, including the assessment of their morphology, sterility and potential toxicity. In the latter part of the book, chapters cover nanotoxicology, regulatory aspect and clinical trials, ending with an overview of several case studies and a look towards future developments. Discusses the issues surrounding nanoparticulate products, based on personal experience of their formulation Provides an overview of new application areas, including RNA interference Outlines the pros and cons of nanoparticulate products, and discusses how these may influence their route into the commercial sector

Veterinary Pharmacovigilance

Veterinary Pharmacovigilance
Adverse Reactions to Veterinary Medicinal Products

by Kevin Woodward

  • Publisher : John Wiley & Sons
  • Release : 2009-11-24
  • Pages : 776
  • ISBN : 9781444322941
  • Language : En, Es, Fr & De
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Veterinary Pharmacovigilance: Adverse Reactions to Veterinary Medicinal Products is an in-depth examination of veterinary pharmacovigilance, looking at the scientific methodologies involved, the role of regulatory agencies and legislation, and the underpinning science. Edited by a renowned expert with over 20 years of experience in the field, it draws together the expertise of authors from around the world.

Pharmacoepidemiology

Pharmacoepidemiology
A Book

by Brian L. Strom,Stephen E. Kimmel,Sean Hennessy

  • Publisher : John Wiley & Sons
  • Release : 2012-03-05
  • Pages : 976
  • ISBN : 0470654759
  • Language : En, Es, Fr & De
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Now in its fifth edition, Pharmacoepidemiology defines the discipline and provides the most comprehensive guidance of any book on the topic. Written by world renowned experts in the field, this valuable text surveys the research designs and sources of data available for pharmacoepidemiologic research, and provides descriptions of various automated data systems, along with the advantages and disadvantages of each. Incorporating perspectives from academia, industry and regulatory agencies, this book provides detailed insights into all aspects of pharmacoepidemiology.

Stem Cell Bioprocessing

Stem Cell Bioprocessing
For Cellular Therapy, Diagnostics and Drug Development

by Tiago G Fernandes,Maria Margarida Diogo,Joaquim M. S. Cabral

  • Publisher : Elsevier
  • Release : 2013-11-15
  • Pages : 236
  • ISBN : 1908818301
  • Language : En, Es, Fr & De
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Stem cell bioprocessing describes the main large-scale bioprocessing strategies for both stem cell culture and purification, envisaging the application of these cells for regenerative medicine and drug screening. Bioreactor configurations are described, including their applications for stem cell expansion, and stem cell separation techniques such as isolation and purification are discussed. Basic definitions are provided concerning the different types of stem cells, from adult stem cells to the more recent induced pluripotent stem cells. The main characteristics of these different stem cell types are described, alongside the molecular mechanisms underlying their self-renewal and differentiation. The book also focuses on methodologies currently used for in vitro stem cell culture under static conditions, including the challenge of xeno-free culture conditions, as well as culture parameters that influence stem cell culture. Approaches for both stem cell culture and separation in micro-scale conditions are presented, including the use of cellular microarrays for high-throughput screening of the effect of both soluble and extracellular matrix molecules. A further section is dedicated to application of stem cells for regenerative medicine. Maintains a unique focus on both the basic stem cell biology concepts, and their translation to large-scale bioprocessing approaches Envisages the use of stem cells in regenerative medicine and drug screening applications Discusses the application of microscale techniques as a tool to perform basic stem cell biology studies

Formulation tools for Pharmaceutical Development

Formulation tools for Pharmaceutical Development
A Book

by J E Aguilar

  • Publisher : Elsevier
  • Release : 2013-09-30
  • Pages : 304
  • ISBN : 1908818506
  • Language : En, Es, Fr & De
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A range of new and innovative tools used for preformulation and formulation of medicines help optimize pharmaceutical development projects. Such tools also assist with the performance evaluation of the pharmaceutical process, allowing any potential gaps to be identified. These tools can be applied in both basic research and industrial environment. Formulation tools for pharmaceutical development considers these key research and industrial tools. Nine chapters by leading contributors cover: Artificial neural networks technology to model, understand, and optimize drug formulations; ME_expert 2.0: a heuristic decision support system for microemulsions formulation development; Expert system for the development and formulation of push-pull osmotic pump tablets containing poorly water-soluble drugs; SeDeM Diagram: an expert system for preformulation, characterization and optimization of tables obtained by direct compression; New SeDeM-ODT expert system: an expert system for formulation of orodispersible tablets obtained by direct compression; and 3D-cellular automata in computer-aided design of pharmaceutical formulations: mathematical concept and F-CAD software. Coverage of artificial intelligence tools, new expert systems, understanding of pharmaceutical processes, robust development of medicines, and new ways to develop medicines Development of drugs and medicines using mathematical tools Compilation of expert system developed around the world

Computer-Aided Applications in Pharmaceutical Technology

Computer-Aided Applications in Pharmaceutical Technology
A Book

by Jelena Djuris

  • Publisher : Elsevier
  • Release : 2013-04-10
  • Pages : 300
  • ISBN : 1908818328
  • Language : En, Es, Fr & De
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Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed drugs to be formulated into commercially available products. Both formulation and process development can be optimized by means of statistically organized experiments, artificial intelligence and other computational methods. Simultaneous development and investigation of pharmaceutical products and processes enables application of quality by design concept that is being promoted by the regulatory authorities worldwide. Computer-aided applications in pharmaceutical technology covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with emphasis of their application in process control, neural computing (artificial neural networks, fuzzy logic and decision trees, evolutionary computing and genetic algorithms, self-organizing maps), computer-aided biopharmaceutical characterization as well as application of computational fluid dynamics in pharmaceutical technology. All of these techniques are essential tools for successful building of quality into pharmaceutical products and processes from the early stage of their development to selection of the optimal ones. In addition to theoretical aspects of various methods, the book provides numerous examples of their application in the field of pharmaceutical technology. A comprehensive review of the current state of the art on various computer aided applications in pharmaceutical technology Case studies are presented in order to facilitate understanding of various concepts in computer-aided applications

An Introduction to Pharmaceutical Sciences

An Introduction to Pharmaceutical Sciences
Production, Chemistry, Techniques and Technology

by Jiben Roy

  • Publisher : Elsevier
  • Release : 2011-07-25
  • Pages : 446
  • ISBN : 1908818042
  • Language : En, Es, Fr & De
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This textbook is written as a unified approach to various topics, ranging from drug discovery to manufacturing, techniques and technology, regulation and marketing. The key theme of the book is pharmaceuticals - what every student of pharmaceutical sciences should know: from the active pharmaceutical ingredients to the preparation of various dosage forms along with the relevant chemistry, this book makes pharmaceuticals relevant to undergraduate students of pharmacy and pharmaceutical sciences. This book explains how a particular drug was discovered and then converted from lab-scale to manufacturing scale, to the market. It explains the motivation for drug discovery, the reaction chemistry involved, experimental difficulties, various dosage forms and the reasoning behind them, mechanism of action, quality assurance and role of regulatory agencies. After having a course based on this book, the student will be able to understand: 1) the career prospects in the pharmaceutical industry, 2) the need for interdisciplinary teamwork in science, 3) the techniques and technology involved in making pharmaceuticals starting from bulk drugs, and 4) different dosage forms and critical factors in the development of pharmaceutical formulations in relation to the principles of chemistry. A few blockbuster drugs including atorvastatin, sildanefil, ranitidine, ciprofloxacin, amoxicillin, and the longest serving drugs such as aspirin and paracetamol are discussed in detail. Finally, the book also covers the important current pharmaceutical issues like quality control, safety, counterfeiting and abuse of drugs, and future prospects for pharmaceutical industry. Unified approach explaining drug discovery, bulk drug manufacturing, formulation of dosage forms, with pharmacological and therapeutic actions Manufacturing processes of representative active pharmaceutical ingredients and their chemistry plus formulation of dosage forms presented in this book are based on actual industrial processes Covers many aspects relevant to students of the pharmaceutical sciences or newly employed pharmaceutical researchers/employees. It contains summary information about regulatory agencies of different countries

Translational Biology in Medicine

Translational Biology in Medicine
A Book

by M. Montano

  • Publisher : Elsevier
  • Release : 2014-12-08
  • Pages : 228
  • ISBN : 1908818654
  • Language : En, Es, Fr & De
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The recent emphasis in biomedical research on translational biology and personalized medicine is revolutionizing conceptual and experimental approaches to understanding and improving human health. Translational Biology in Medicine begins with an introduction to experimental model systems for disease, such as cell lines, primary cells, stem cells and animal models for disease, followed by a systematic description of genetic and genomic profiling and biomarker validation currently used in biomedical research. Examples of translation studies that have used these models and methods are presented, including studies in aging, tissue repair and chronic infection, each with an emphasis on how personalized medicine is transforming biomedicine. Bioethical considerations in translational study design and bioethical considerations in biomedical research are then covered, before concluding remarks, and a look towards the future of personalized medicine. Describes cellular and animal model systems used in translational research Discusses the use of blood, genetic and genomic biomarkers for disease Presents translational studies in aging, tissue repair and infectious disease biomedicine

Open Source Software in Life Science Research

Open Source Software in Life Science Research
Practical Solutions to Common Challenges in the Pharmaceutical Industry and Beyond

by Lee Harland,Mark Forster

  • Publisher : Elsevier
  • Release : 2012-10-31
  • Pages : 582
  • ISBN : 1908818247
  • Language : En, Es, Fr & De
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The free/open source approach has grown from a minor activity to become a significant producer of robust, task-orientated software for a wide variety of situations and applications. To life science informatics groups, these systems present an appealing proposition - high quality software at a very attractive price. Open source software in life science research considers how industry and applied research groups have embraced these resources, discussing practical implementations that address real-world business problems. The book is divided into four parts. Part one looks at laboratory data management and chemical informatics, covering software such as Bioclipse, OpenTox, ImageJ and KNIME. In part two, the focus turns to genomics and bioinformatics tools, with chapters examining GenomicsTools and EBI Atlas software, as well as the practicalities of setting up an ‘omics’ platform and managing large volumes of data. Chapters in part three examine information and knowledge management, covering a range of topics including software for web-based collaboration, open source search and visualisation technologies for scientific business applications, and specific software such as DesignTracker and Utopia Documents. Part four looks at semantic technologies such as Semantic MediaWiki, TripleMap and Chem2Bio2RDF, before part five examines clinical analytics, and validation and regulatory compliance of free/open source software. Finally, the book concludes by looking at future perspectives and the economics and free/open source software in industry. Discusses a broad range of applications from a variety of sectors Provides a unique perspective on work normally performed behind closed doors Highlights the criteria used to compare and assess different approaches to solving problems

Pharmacoepidemiology and Pharmacovigilance

Pharmacoepidemiology and Pharmacovigilance
Synergistic Tools to Better Investigate Drug Safety

by Sabrina Nour,Gilles Plourde

  • Publisher : Academic Press
  • Release : 2018-10-17
  • Pages : 144
  • ISBN : 012816381X
  • Language : En, Es, Fr & De
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Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety examines the role of pharmacoepidemiologic studies in drug development and its use as a prevention tool in pharmacovigilance activities. The book introduces the various epidemiologic tools and study designs commonly used for the surveillance of drug-related adverse effects and reviews the strengths and weaknesses of each. Criticisms surrounding pharmacoepidemiologic research and issues that often interfere or complicate the conduct and interpretation of these studies are also explored. Case studies illustrate the passive and active surveillance of adverse drug reactions in clinical situations, covering important pharmacoepidemiologic concepts like health risk management and safety. The book helps pharmaceutical industry groups engaged in drug safety, clinical investigators, medical evaluators and those seeking regulatory approval enhance the safety of the drug development process for all patient populations. Describes the main prevention tools for the passive and active surveillance of adverse effects associated with drugs Provides examples of diseases in various contexts related to clinical studies and the analysis of adverse drug reactions Offers case studies that illustrate real-life clinical situations Discusses important concepts related to pharmacoepidemiology and pharmacovigilance