Therapeutic Risk Management of Medicines Book

Therapeutic Risk Management of Medicines


  • Author : Stephen J. Mayall
  • Publisher : Elsevier
  • Release Date : 2014-04-16
  • Genre: Medical
  • Pages : 448
  • ISBN 10 : 9781908818270

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Therapeutic Risk Management of Medicines Excerpt :

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 Book

Therapeutic Risk


  • Author : William Howard Wallace Inman
  • Publisher : John Wiley & Sons
  • Release Date : 1988
  • Genre: Chemotherapy
  • Pages : 103
  • ISBN 10 : UOM:39015014491685

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Therapeutic Risk Excerpt :

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.

Smart Health Choices Book
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Smart Health Choices


  • Author : Les Irwig
  • Publisher : Judy Irwig
  • Release Date : 2007-09
  • Genre: Health
  • Pages : 256
  • ISBN 10 : 9781905140176

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Smart Health Choices Excerpt :

This book aims to help consumers and practitioners develop the skills to assess health advice - and hopefully to make decisions that will improve the quality of their care. For some people, making better-informed decisions could be life saving. We hope that it will be useful if you are struggling to come to terms with an illness or injury, and the best ways of managing it. Or you may simply want to lead a healthier life, and may be wondering how to make sense of the often conflicting flood of health information that deluges us every day, through the media, and from our friends and health practitioners.

Therapeutic Protein Drug Products Book

Therapeutic Protein Drug Products


  • Author : Brian K Meyer
  • Publisher : Elsevier
  • Release Date : 2012-01-02
  • Genre: Medical
  • Pages : 200
  • ISBN 10 : 9781908818102

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Therapeutic Protein Drug Products Excerpt :

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

Pain Management and the Opioid Epidemic Book

Pain Management and the Opioid Epidemic


  • Author : National Academies of Sciences, Engineering, and Medicine
  • Publisher : National Academies Press
  • Release Date : 2017-09-28
  • Genre: Medical
  • Pages : 482
  • ISBN 10 : 9780309459570

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Pain Management and the Opioid Epidemic Excerpt :

Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Communicating about Risks and Safe Use of Medicines Book

Communicating about Risks and Safe Use of Medicines


  • Author : Priya Bahri
  • Publisher : Springer Nature
  • Release Date : 2020-06-17
  • Genre: Medical
  • Pages : 504
  • ISBN 10 : 9789811530135

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Communicating about Risks and Safe Use of Medicines Excerpt :

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.

Practical Approaches to Risk Minimisation for Medicinal Products Book

Practical Approaches to Risk Minimisation for Medicinal Products


  • Author : World Health Organization
  • Publisher : Unknown
  • Release Date : 2015-03-02
  • Genre: Medical
  • Pages : 184
  • ISBN 10 : 9290360844

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Practical Approaches to Risk Minimisation for Medicinal Products Excerpt :

Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large. Previous reports from CIOMS I - VIII provided practical guidance in some essential components of risk management such as terminology and reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection. Beyond the detection, identification, and characterization of risk, "risk minimization" is used as an umbrella term for the prevention or mitigation of an undesirable outcome. Risk management always includes tools for "routine risk minimization" such as product information, the format depending on the jurisdiction, to inform the patient and the prescriber, all of which serve to prevent or mitigate adverse effects. Until this current CIOMS IX document, limited guidance has been available on how to determine which risks need "additional risk minimization," select the appropriate tools, apply and implement such tools globally and locally, and measure if they are effective and valuable. Included in the report is a CIOMS framework for the evaluation of effectiveness of risk minimization, a discussion of future trends and developments, an annex specifically addressing vaccines, and examples from real life.

Human Drug Metabolism Book

Human Drug Metabolism


  • Author : Michael D. Coleman
  • Publisher : John Wiley & Sons
  • Release Date : 2020-02-19
  • Genre: Science
  • Pages : 680
  • ISBN 10 : 9781119458562

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Human Drug Metabolism Excerpt :

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 Illus

The Perception and Management of Drug Safety Risks Book

The Perception and Management of Drug Safety Risks


  • Author : Bruno Horisberger
  • Publisher : Springer Science & Business Media
  • Release Date : 2012-12-06
  • Genre: Medical
  • Pages : 216
  • ISBN 10 : 9783642742729

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The Perception and Management of Drug Safety Risks Excerpt :

In the past two decades public debate about the risks, benefits, and safety associated with drugs has intensified. Public disputes over risks are brought to court when individuals seek compensation for health problems attributed to a pharmaceutical product. The issue reaches legislatures and regulatory agencies when consumer advocates seek to influence the standards of drug usage. Front-page news tends to focus on accidents or other risk events with drugs. Drug risk and drug safety have become an important political issue. Drug regulat ory agencies have been instituted, and their responsibility has increased. The approval to market a drug is dependent on a set of sophisticated studies executed according to strict protocols and scientifically defined criteria. Drug surveillance activities have gained recognition, and reporting systems to identify drug safety problems have been strengthened. The understanding and management of drug safety is, nonetheless, beset by doubts, disagreements, and disputes. Conflict occurs over the significance of risk, the adequacy of evidence, the methodologies used to evaluate and measure risk, the standards that guide regulation, and the optimal means of communicating risk information to the public.

Therapeutic Antibody Engineering Book

Therapeutic Antibody Engineering


  • Author : William R Strohl
  • Publisher : Elsevier
  • Release Date : 2012-10-16
  • Genre: Science
  • Pages : 696
  • ISBN 10 : 9781908818096

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Therapeutic Antibody Engineering Excerpt :

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 Book

Gene therapy


  • Author : Surendra Nimesh
  • Publisher : Elsevier
  • Release Date : 2013-10-31
  • Genre: Science
  • Pages : 380
  • ISBN 10 : 9781908818645

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Gene therapy Excerpt :

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

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

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


  • Author : Council of Europe
  • Publisher : Council of Europe
  • Release Date : 2000-01-01
  • Genre: Political Science
  • Pages : 222
  • ISBN 10 : 9287144044

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

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.

Nanoparticulate Drug Delivery Book

Nanoparticulate Drug Delivery


  • Author : Vandana Patravale
  • Publisher : Elsevier
  • Release Date : 2012-10-31
  • Genre: Medical
  • Pages : 244
  • ISBN 10 : 9781908818195

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Nanoparticulate Drug Delivery Excerpt :

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

Transporters in Drug Discovery and Development Book

Transporters in Drug Discovery and Development


  • Author : Yurong Lai
  • Publisher : Woodhead Publishing
  • Release Date : 2014-08-22
  • Genre: Medical
  • Pages : 780
  • ISBN 10 : 9781908818287

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Transporters in Drug Discovery and Development Excerpt :

Written by a leading researcher in the field, Transporters in Drug Discovery and Development provides a comprehensive and practical guide to drug transporter families that are the most important for drug discovery and development. It covers: an overview of transporter families and organ distribution; clinical relevant drug-drug interaction; clinical relevant polymorphism; drug transporter related pharmacokinetic, pharmacodynamics and toxicity; in vitro/in vivo probes of drug transport studies; the practical methodologies of industrial transporter screening and translational aspect in drug discovery and developments. A comprehensive overview of drug transporter families and their clinical relevance in drug discovery and development Balanced coverage of molecular biology aspects and functional outcomes State of art knowledge related to transporter-mediated DDI and the clinical relevance in pharmacokinetics, dynamics, and toxicity