Real World Evidence In Drug Development And Evaluation
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Real World Evidence In Drug Development And Evaluation
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Author : Harry Yang
language : en
Publisher: CRC Press
Release Date : 2021-01-11
Real World Evidence In Drug Development And Evaluation written by Harry Yang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-01-11 with Mathematics categories.
Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions. Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise
Real World Evidence In Drug Development And Evaluation
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Author : Harry Yang
language : en
Publisher: CRC Press
Release Date : 2021-01-11
Real World Evidence In Drug Development And Evaluation written by Harry Yang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-01-11 with Mathematics categories.
Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions. Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise
Registries For Evaluating Patient Outcomes
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Author : Richard E. Gliklich
language : en
Publisher:
Release Date : 2014
Registries For Evaluating Patient Outcomes written by Richard E. Gliklich and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014 with Diseases categories.
Case Studies In Modern Drug Discovery And Development
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Author : Xianhai Huang
language : en
Publisher: John Wiley & Sons
Release Date : 2012-05-29
Case Studies In Modern Drug Discovery And Development written by Xianhai Huang and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-05-29 with Medical categories.
Learn why some drug discovery and development efforts succeed . . . and others fail Written by international experts in drug discovery and development, this book sets forth carefully researched and analyzed case studies of both successful and failed drug discovery and development efforts, enabling medicinal chemists and pharmaceutical scientists to learn from actual examples. Each case study focuses on a particular drug and therapeutic target, guiding readers through the drug discovery and development process, including drug design rationale, structure-activity relationships, pharmacology, drug metabolism, biology, and clinical studies. Case Studies in Modern Drug Discovery and Development begins with an introductory chapter that puts into perspective the underlying issues facing the pharmaceutical industry and provides insight into future research opportunities. Next, there are fourteen detailed case studies, examining: All phases of drug discovery and development from initial idea to commercialization Some of today's most important and life-saving medications Drugs designed for different therapeutic areas such as cardiovascular disease, infection, inflammation, cancer, metabolic syndrome, and allergies Examples of prodrugs and inhaled drugs Reasons why certain drugs failed to advance to market despite major research investments Each chapter ends with a list of references leading to the primary literature. There are also plenty of tables and illustrations to help readers fully understand key concepts, processes, and technologies. Improving the success rate of the drug discovery and development process is paramount to the pharmaceutical industry. With this book as their guide, readers can learn from both successful and unsuccessful efforts in order to apply tested and proven science and technologies that increase the probability of success for new drug discovery and development projects.
Rare Diseases And Orphan Products
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-04-03
Rare Diseases And Orphan Products written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-04-03 with Medical categories.
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Textbook Of Pharmacoepidemiology
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Author : Brian L. Strom
language : en
Publisher: John Wiley & Sons
Release Date : 2013-05-13
Textbook Of Pharmacoepidemiology written by Brian L. Strom and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-13 with Medical categories.
The Textbook of Pharmacoepidemiology provides a streamlined text for evaluating the safety and effectiveness of medicines. It includes a brief introduction to pharmacoepidemiology as well as sections on data sources, methodology and applications. Each chapter includes key points, case studies and essential references. One-step resource to gain understanding of the subject of pharmacoepidemiology at an affordable price Gives a perspective on the subject from academia, pharmaceutical industry and regulatory agencies Designed for students with basic knowledge of epidemiology and public health Includes many case studies to illustrate pharmacoepidemiology in real clinical setting
Case Studies In Innovative Clinical Trials
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Author : Kristine Broglio
language : en
Publisher: CRC Press
Release Date : 2023-11-27
Case Studies In Innovative Clinical Trials written by Kristine Broglio and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-27 with Medical categories.
Drug development is a strictly regulated area. As such, marketing approval of a new drug depends heavily, if not exclusively, on evidence generated from clinical trials. Drug development has seen tremendous innovation in science and technology that has revolutionized the treatment of some diseases. And yet, the statistical design and practical conduct of the clinical trials used to test new therapeutics for safety and efficacy have changed very little over the decades. Our approach to clinical trials is steeped in convention and tradition. The large, fixed, randomized controlled trial methods that have been the gold standard are well understood and expected by many trial stakeholders. However, this approach is not well suited to all aspects of modern drug development and the current competitive landscape. We now see new therapies that target a small fraction of the patient population, rare diseases with high unmet medical needs, and pediatric populations that must wait for years for new drug approvals from the time that therapies are approved in adults. Large randomized clinical trials are at best inefficient and at worst completely infeasible in many modern clinical settings. Advances in technology and data infrastructure call for innovations in clinical trial design. Despite advances in statistical methods, the availability of information, and computing power, the actual experience with innovative design in clinical trials across industry and academia is limited. This book will be an important showcase of the potential for these innovative designs in modern drug development and will be an important resource to guide those who wish to undertake them for themselves. This book is ideal for professionals in the pharmaceutical industry and regulatory agencies, but it will also be useful to academic researchers, faculty members, and graduate students in statistics, biostatistics, public health, and epidemiology due to its focus on innovation. Key Features: Is written by pharmaceutical industry experts, academic researchers, and regulatory reviewers; this is the first book providing a comprehensive set of case studies related to statistical methodology, implementation, regulatory considerations, and communication of complex innovative trial design Has a broad appeal to a multitude of readers across academia, industry, and regulatory agencies Each contribution is a practical case study that can speak to the benefits of an innovative approach but also balance that with the real-life challenges encountered A complete understanding of what is actually being done in modern clinical trials will broaden the reader’s capabilities and provide examples to first mimic and then customize and expand upon when exploring these ideas on their own
Real World Evidence Generation And Evaluation Of Therapeutics
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2017-07-05
Real World Evidence Generation And Evaluation Of Therapeutics written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-07-05 with Medical categories.
The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of this wealth of real-world data could be numerous and varied, ranging from the ability to determine both large-scale and patient-specific effects of treatments to the ability to assess how therapeutics affect patients' lives through measurement of lifestyle changes. In October 2016, the National Academies of Sciences, Engineering, and Medicine held a workshop to facilitate dialogue among stakeholders about the opportunities and challenges for incorporating real-world evidence into all stages in the process for the generation and evaluation of therapeutics. Participants explored unmet stakeholder needs and opportunities to generate new kinds of evidence that meet those needs. This publication summarizes the presentations and discussions from the workshop.
Data Science Ai And Machine Learning In Drug Development
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Author : Harry Yang
language : en
Publisher: CRC Press
Release Date : 2022-10-03
Data Science Ai And Machine Learning In Drug Development written by Harry Yang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-10-03 with Business & Economics categories.
The confluence of big data, artificial intelligence (AI), and machine learning (ML) has led to a paradigm shift in how innovative medicines are developed and healthcare delivered. To fully capitalize on these technological advances, it is essential to systematically harness data from diverse sources and leverage digital technologies and advanced analytics to enable data-driven decisions. Data science stands at a unique moment of opportunity to lead such a transformative change. Intended to be a single source of information, Data Science, AI, and Machine Learning in Drug Research and Development covers a wide range of topics on the changing landscape of drug R & D, emerging applications of big data, AI and ML in drug development, and the build of robust data science organizations to drive biopharmaceutical digital transformations. Features Provides a comprehensive review of challenges and opportunities as related to the applications of big data, AI, and ML in the entire spectrum of drug R & D Discusses regulatory developments in leveraging big data and advanced analytics in drug review and approval Offers a balanced approach to data science organization build Presents real-world examples of AI-powered solutions to a host of issues in the lifecycle of drug development Affords sufficient context for each problem and provides a detailed description of solutions suitable for practitioners with limited data science expertise
Insights In Regulatory Science 2021
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Author : Bruno Sepodes
language : en
Publisher: Frontiers Media SA
Release Date : 2022-11-04
Insights In Regulatory Science 2021 written by Bruno Sepodes and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-11-04 with Medical categories.