Benefit-Risk Assessment of Medicines PDF Download

Author: James Leong
Publisher: Springer
ISBN: 3319158058
Category : Medical
Languages : en
Pages : 326

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Book Description
This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.

Author: Andreas Sashegyi
Publisher: CRC Press
ISBN: 143986795X
Category : Mathematics
Languages : en
Pages : 216

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Book Description
Many practitioners in the pharmaceutical industry are still largely unfamiliar with benefit-risk assessment, despite its growing prominence in drug development and commercialization. Helping to alleviate this knowledge gap, Benefit-Risk Assessment in Pharmaceutical Research and Development provides a succinct overview of the key considerations rele

Author: Brian L. Strom
Publisher: John Wiley & Sons
ISBN: 1119413419
Category : Medical
Languages : en
Pages : 1220

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Book Description
Dieses Lehrbuch, ein wegweisender Klassiker, bietet in der 6. Auflage noch mehr Inhalte für Leser, die aktuelle Informationen zur Pharmakoepidemiologie benötigen. Die vorliegende Auflage wurde vollständig überarbeitet und aktualisiert. Sie bietet einen Überblick über sämtliche Facetten des Fachgebiets, aus Sicht von Lehre und Forschung, aus Sicht der Industrie und von Regulierungsbehörden. Datenquellen, Anwendungen und Methodiken werden verständlich erläutert.

Author: Stephen J. Mayall
Publisher: Elsevier
ISBN: 1908818271
Category : Medical
Languages : en
Pages : 435

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Book Description
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

Author: Hans C. Korting
Publisher: CRC Press
ISBN: 9781439805916
Category : Medical
Languages : en
Pages : 402

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Book Description
The use of drugs as remedies for various types of diseases has a long tradition; however, it has only been recently recognized that the value of any given compound must be evaluated in light of its benefit to risk ratio. When prescribing drugs, physicians must look at the big picture of the drug's benefits in relation to its side effects and possib

Author: Chris J. van Boxtel
Publisher: John Wiley & Sons
ISBN: 9780471899273
Category : Medical
Languages : en
Pages : 738

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Book Description
This is an inclusive reference exploring the scientific basis and practice of drug therapy. The key concept is to look at the balance between the benefits and risks of drugs but in this context also the social impact which drugs have in modern societies is highlighted. Taking an evidence-based approach to the problem, the practice of clinical pharmacology and pharmacotherapy in the developing as well as the developed world is examined. For this purpose the book * Covers general clinical pharmacology, pharmacology of various drug groups and the treatments specific to various diseases * Gives guidance on how doctors should act so that drugs can be used effectively and safely * Encourages the rational use of drugs in society This book brings together a large amount of excellent content that will be invaluable for anyone working within, or associated with, the field of clinical pharmacology and pharmacotherapy - undergraduates, postgraduates, regulatory authorities and the pharmaceutical industry.

Author: Steven Piantadosi
Publisher: Springer Nature
ISBN: 3319526367
Category : Medical
Languages : en
Pages : 2573

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Book Description
This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

Author: Graeme Laurie
Publisher:
ISBN: 1108576095
Category : Law
Languages : en
Pages : 444

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Book Description
The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues.

Author: Jerry Avorn, M.D.
Publisher: Vintage
ISBN: 0307489752
Category : Medical
Languages : en
Pages : 476

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Book Description
If you believe that the latest blockbuster medication is worth a premium price over your generic brand, or that doctors have access to all the information they need about a drug’s safety and effectiveness each time they write a prescription, Dr. Jerry Avorn has some sobering news. Drawing on more than twenty-five years of patient care, teaching, and research at Harvard Medical School, he shares his firsthand experience of the wide gap in our knowledge of the effectiveness of one medication as compared to another. In Powerful Medicines, he reminds us that every pill we take represents a delicate compromise between the promise of healing, the risk of side effects, and an increasingly daunting price. The stakes on each front grow higher every year as new drugs with impressive power, worrisome side effects, and troubling costs are introduced. This is a comprehensive behind-the-scenes look at issues that affect everyone: our shortage of data comparing the worth of similar drugs for the same condition; alarming lapses in the detection of lethal side effects; the underuse of life-saving medications; lavish marketing campaigns that influence what doctors prescribe; and the resulting upward spiral of costs that places vital drugs beyond the reach of many Americans. In this engagingly written book, Dr. Avorn asks questions that will interest every consumer: How can a product judged safe by the Food and Drug Administration turn out to have unexpectedly lethal side effects? Why has the nation’s drug bill been growing at nearly 20 percent per year? How can physicians and patients pick the best medication in its class? How do doctors actually make their prescribing decisions, and why do those decisions sometimes go wrong? Why do so many Americans suffer preventable illnesses and deaths that proper drug use could have averted? How can the nation gain control over its escalating drug budget without resorting to rationing or draconian governmental controls? Using clinical case histories taken from his own work as a practitioner, researcher, and advocate, Dr. Avorn demonstrates the impressive power of the well-conceived prescription as well as the debacles that can result when medications are misused. He describes an innovative program that employs the pharmaceutical industry’s own marketing techniques to reduce use of some of the most overprescribed and overpriced products. Powerful Medicines offers timely and practical advice on how the nation can improve its drug-approval process, and how patients can work with doctors to make sure their prescriptions are safe, effective, and as affordable as possible. This is a passionate and provocative call for action as well as a compelling work of clear-headed science.

Author: William Wang
Publisher: CRC Press
ISBN: 0429949995
Category : Mathematics
Languages : en
Pages : 347

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Book Description
Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual adverse event reports however recently there had been a shift towards aggregate analysis to better understand the scope of product risks. Written to be accessible not only to statisticians but also to safety scientists with a quantitative interest, this book aims to bridge the gap in knowledge between medical and statistical fields creating a truly multi-disciplinary approach that is very much needed for 21st century safety evaluation.