Risk Benefit Analysis In Drug Research

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Risk-Benefit Analysis in Drug Research

Author : J.F. Cavalla
Publisher : Springer Science & Business Media
ISBN 13 : 9401571325
Total Pages : 199 pages
Book Rating : 4.4/5 (15 download)

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Book Synopsis Risk-Benefit Analysis in Drug Research by : J.F. Cavalla

Download or read book Risk-Benefit Analysis in Drug Research written by J.F. Cavalla and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 199 pages. Available in PDF, EPUB and Kindle. Book excerpt: The appreciation of risk like the awareness of beauty lies very much in the eyes of the beholder. It involves a value judgement and can never be absolute. Yet paradoxically, modern society is demanding ever greater degrees of safety in the medicines it takes, to the extent that nothing short of the total absence of risk will be tolerated. Since 1960, and mainly as a result of the thalidomide tragedy, governmental regulation of testing and use of new medicines has grown apace throughout the world. It has derived impetus not only from the understandable wish of the public to seek protection, but also from the anxiety of bureaucrats and politicians not to be seen to have made mistakes. Both these concerns have been inflamed by the recognition of the media that all drugs make news and horror drugs make the best news of all. Prior to this time the physician and his cures enjoyed a relatively supportive public. It was true that quacks existed and were recognized as such but, in the main, people wanted to take medicines and expected them to do them good.

Benefit-Risk Assessment in Pharmaceutical Research and Development

Author : Andreas Sashegyi
Publisher : CRC Press
ISBN 13 : 1439867941
Total Pages : 222 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Benefit-Risk Assessment in Pharmaceutical Research and Development by : Andreas Sashegyi

Download or read book Benefit-Risk Assessment in Pharmaceutical Research and Development written by Andreas Sashegyi and published by CRC Press. This book was released on 2013-11-27 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 relevant to benefit-risk assessment across the pharmaceutical R&D spectrum, from early clinical development to late-stage development to regulatory review to post-launch assessment. The book first presents interpretations of benefit and risk in the context of a molecule moving from preclinical evaluation into its early testing in humans. It next considers benefit and risk characterization and assessment during a molecule’s journey from its clinical evaluation in humans through its submission to regulators for marketing approval. Throughout these sections, the book offers insight into the role of benefit-risk assessment in heightening understanding among key stakeholders by shaping questions and guiding discussions among scientists, physicians, developers, and regulatory agencies. The book also focuses on a molecule’s entry into the marketplace as a drug available for consumption by people. It explores the role of benefit-risk assessment as the relevance of carefully collected clinical efficacy and safety metrics fades in the wake of real-world use and evidence of effectiveness and safety. Bringing together the expertise of 15 contributors from academia and the industry, this book offers an easy-to-read guide to the various facets of benefit-risk assessment in the major stages of pharmaceutical R&D. Suitable for those in both technical and managerial roles, it enables readers to communicate more effectively across their development chain as well as rationally and thoughtfully embed benefit-risk assessment into their R&D processes.

Understanding the Benefits and Risks of Pharmaceuticals

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309107385
Total Pages : 98 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Understanding the Benefits and Risks of Pharmaceuticals by : Institute of Medicine

Download or read book Understanding the Benefits and Risks of Pharmaceuticals written by Institute of Medicine and published by National Academies Press. This book was released on 2007-09-14 with total page 98 pages. Available in PDF, EPUB and Kindle. Book excerpt: All pharmaceutical products have inherent risks, and their use involves trade-offs between their therapeutic benefits and their risks. However, the public has a limited understanding of the benefits and risks of drugs, and many individuals believe that drugs approved by the U.S. Food and Drug Administration (FDA) carry no risks. The FDA is responsible for evaluating and balancing the potential risks of drugs with their potential benefits. Assessing, managing, and communicating the benefit-risk profile of a pharmaceutical product is a complex and nuanced scientific, political, and sociological challenge. Once the assessment is made, the FDA is then responsible for managing how to communicate these risks and make healthcare decisions based on them. To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop entitled Understanding the Benefits and Risks of Pharmaceuticals, with the broad goals of gaining a better understanding of the current system used to evaluate benefit and risk, and to identify opportunities for improvement. This workshop was held in Washington, D.C., on May 30-31, 2006. The benefit-risk profiles of pharmaceuticals are constantly evolving as new data are collected throughout the life cycle of a drug. Discussions during the workshop focused on the following: (1) premarket assessment, during which clinical trial data are used to assess benefit and risk; (2) communication of that information to prescribing physicians and their patients; (3) healthcare decisions made by prescribing physicians and their patients; and (4) the accumulation of benefit-risk information from postmarketing experience, which feeds back into the other phases. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary explains in detail the discussions during this workshop.

Weighing Benefits and Risks in Pharmaceutical Use: A Consumer's Guide

Author :
Publisher : Am Cncl on Science, Health
ISBN 13 :
Total Pages : 28 pages
Book Rating : 4./5 ( download)

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Book Synopsis Weighing Benefits and Risks in Pharmaceutical Use: A Consumer's Guide by :

Download or read book Weighing Benefits and Risks in Pharmaceutical Use: A Consumer's Guide written by and published by Am Cncl on Science, Health. This book was released on 2005 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Cambridge Handbook of Health Research Regulation

Author : Graeme Laurie
Publisher :
ISBN 13 : 1108576095
Total Pages : 444 pages
Book Rating : 4.1/5 (85 download)

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Book Synopsis The Cambridge Handbook of Health Research Regulation by : Graeme Laurie

Download or read book The Cambridge Handbook of Health Research Regulation written by Graeme Laurie and published by . This book was released on 2021-06-09 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues.

Benefit-Risk Assessment of Medicines

Author : James Leong
Publisher : Adis
ISBN 13 : 9783319367675
Total Pages : 0 pages
Book Rating : 4.3/5 (676 download)

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Book Synopsis Benefit-Risk Assessment of Medicines by : James Leong

Download or read book Benefit-Risk Assessment of Medicines written by James Leong and published by Adis. This book was released on 2016-10-13 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Quantitative Evaluation of Safety in Drug Development

Author : Qi Jiang
Publisher : CRC Press
ISBN 13 : 1466555475
Total Pages : 374 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Quantitative Evaluation of Safety in Drug Development by : Qi Jiang

Download or read book Quantitative Evaluation of Safety in Drug Development written by Qi Jiang and published by CRC Press. This book was released on 2014-12-08 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: State-of-the-Art Methods for Drug Safety AssessmentResponding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product deve

Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309310032
Total Pages : 123 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products by : Institute of Medicine

Download or read book Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products written by Institute of Medicine and published by National Academies Press. This book was released on 2014-12-19 with total page 123 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process itself that might limit the generalizability of results. As a result, regulatory reviewers are consistently required to draw conclusions about a drug's safety and efficacy from imperfect data. Efforts are underway within the drug development community to enhance the evaluation and communication of the benefits and risks associated with pharmaceutical products, aimed at increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. Effectively communicating regulatory decisions necessarily includes explanation of the impact of uncertainty on decision making. On February 12 and May 12, 2014, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held public workshops to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, and to consider their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions on February 12 were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. The May 12 workshop presentations and discussions explored tools and approaches to communicating about scientific uncertainties to a range of stakeholders in the drug development process. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products summarizes the presentation and discussion of both events. This report explores potential analytical and communication approaches and identifies key considerations on their development, evaluation, and incorporation into pharmaceutical benefit- risk assessment throughout the entire drug development lifecycle.

Benefit-Risk Appraisal of Medicines

Author : Filip Mussen
Publisher : John Wiley & Sons
ISBN 13 : 0470748125
Total Pages : 304 pages
Book Rating : 4.4/5 (77 download)

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Book Synopsis Benefit-Risk Appraisal of Medicines by : Filip Mussen

Download or read book Benefit-Risk Appraisal of Medicines written by Filip Mussen and published by John Wiley & Sons. This book was released on 2009-08-04 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Benefit-risk assessment is at the centre of the approval process for every new medicine. The ability to assess the risks of a new medicine accurately and to balance these against the benefits the medicine could bring is critical for every regulatory authority and pharmaceutical company. Despite this there are very few tried and tested evaluative models currently available. The authors of this book have developed a new, pioneering tool for the assessment of benefits and risks for new medicines in development. This model utilises a multi-criteria decision analysis which involves selecting, scoring and weighting key benefit and risk attributes and leads to an overall appraisal of benefits and risks of medicines. Benefit-Risk Appraisal of Medicines establishes the background and criteria required to assess benefit and risk in general and reviews the current practices by regulatory authorities and the pharmaceutical industry, including those models currently available. It outlines the development and evaluation of the authors’ new model and analyses the implications of its implementation. Describes an innovative, systematic model which leads to transparent and responsible benefit-risk decision making Contributes important ideas to the debate on benefit-risk appraisal Provides a future framework for benefit-risk appraisal of medicines Benefit-Risk Appraisal of Medicines covers the entire process from the discovery of new medicines to their marketing and is ideal for all those who work in the pharmaceutical industry and regulatory authorities,, as well as post-graduate students of pharmaceutical medicine and clinical pharmacology.

Risk-benefit/cost-benefit

Author : Rita Ricardo-Campbell
Publisher : Hoover Institution Press
ISBN 13 :
Total Pages : 32 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Risk-benefit/cost-benefit by : Rita Ricardo-Campbell

Download or read book Risk-benefit/cost-benefit written by Rita Ricardo-Campbell and published by Hoover Institution Press. This book was released on 1980 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Risk-Benefit Analysis in Drug Research

Author : J F Cavalla
Publisher :
ISBN 13 : 9789401571333
Total Pages : 210 pages
Book Rating : 4.5/5 (713 download)

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Book Synopsis Risk-Benefit Analysis in Drug Research by : J F Cavalla

Download or read book Risk-Benefit Analysis in Drug Research written by J F Cavalla and published by . This book was released on 1981-05-31 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Benefit/Risk Ratio

Author : Hans C. Korting
Publisher : CRC Press
ISBN 13 : 9781439805916
Total Pages : 402 pages
Book Rating : 4.8/5 (59 download)

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Book Synopsis The Benefit/Risk Ratio by : Hans C. Korting

Download or read book The Benefit/Risk Ratio written by Hans C. Korting and published by CRC Press. This book was released on 1998-07-24 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Cost-benefit/cost-effectiveness Research of Drug Abuse Prevention

Author : William J. Bukoski
Publisher :
ISBN 13 :
Total Pages : 242 pages
Book Rating : 4.:/5 (327 download)

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Book Synopsis Cost-benefit/cost-effectiveness Research of Drug Abuse Prevention by : William J. Bukoski

Download or read book Cost-benefit/cost-effectiveness Research of Drug Abuse Prevention written by William J. Bukoski and published by . This book was released on 1998 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Quantitative Drug Safety and Benefit Risk Evaluation

Author : William Wang
Publisher : CRC Press
ISBN 13 : 0429949995
Total Pages : 347 pages
Book Rating : 4.4/5 (299 download)

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Book Synopsis Quantitative Drug Safety and Benefit Risk Evaluation by : William Wang

Download or read book Quantitative Drug Safety and Benefit Risk Evaluation written by William Wang and published by CRC Press. This book was released on 2021-12-30 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Benefit-Risk Assessment Methods in Medical Product Development

Author : Qi Jiang
Publisher : CRC Press
ISBN 13 : 1482259370
Total Pages : 296 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Benefit-Risk Assessment Methods in Medical Product Development by : Qi Jiang

Download or read book Benefit-Risk Assessment Methods in Medical Product Development written by Qi Jiang and published by CRC Press. This book was released on 2017-12-19 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guides You on the Development and Implementation of B–R Evaluations Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B–R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B–R assessments in medicine development and regulation, the need for both a common B–R framework and patient input into B–R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA’s Center for Devices and Radiological Health. The third section examines key elements of B–R evaluations in a product’s life cycle, such as uncertainty evaluation and quantification, quantifying patient B–R trade-off preferences, ways to identify subgroups with the best B–R profiles, and data sources used to assist B–R assessment. The fourth section equips practitioners with tools to conduct B–R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B–R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B–R evaluations.

Medicines and Risk/Benefit Decisions

Author : S.R. Walker
Publisher : Springer Science & Business Media
ISBN 13 : 9400932219
Total Pages : 163 pages
Book Rating : 4.4/5 (9 download)

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Book Synopsis Medicines and Risk/Benefit Decisions by : S.R. Walker

Download or read book Medicines and Risk/Benefit Decisions written by S.R. Walker and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: The third CMR Workshop prov. ided the opportunity for a group of experts from the Industry, academia and the regulatory authorities to meet and discuss ways and means by which risk benefit decisions are made during the various stages of drug development. It became apparent from the discussions that took place in October 1985, at the CIBA Foundation, that decisions are often made with limited data and inadequate methodology. The conclusions drawn from the day's deliberations were as follows: 1. Current methodology for assessing risk and particularly benefits must be improved; 2. Safety must be assessed in association with benefits as it is ultimately the benefit/ risk ratio which should decide the future of medicines; 3. Risks from medicines must always be viewed in relation to the risks from untreated diseases. It seemed to be the consensus of the group that such a meeting was both useful and informative and, hopefully, the publication of these proceedings will stimulate further discussion in this important area which may improve the decision-making process in drug development. The Editors wish to thank the participants for contributing to the Work shop, together with Dr. Cyndy Lumley for providing the initial transcript of the meeting and Mrs Sheila Wright for producing the final version and for carrying out all the additional work that is entailed in producing such a publication. Professor S. R. Walker A. W.

Drug Safety Data

Author : Michael J. Klepper
Publisher : Jones & Bartlett Publishers
ISBN 13 : 1449618553
Total Pages : 332 pages
Book Rating : 4.4/5 (496 download)

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Book Synopsis Drug Safety Data by : Michael J. Klepper

Download or read book Drug Safety Data written by Michael J. Klepper and published by Jones & Bartlett Publishers. This book was released on 2010-09-15 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting. Key features include: * Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports * Pragmatic tips...and mistakes to avoid * Simple explanations of what safety data are collected, and what the data mean * Practical approaches to determining a drug effect and understanding its clinical significance * Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical * Examples of user-friendly data displays that enhance safety signal identification * Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting * Relevant material for the required training of drug safety/pharmacovigilance professionals * SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)