Bayesian Applications In Pharmaceutical Development

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Bayesian Applications In Pharmaceutical Development


Bayesian Applications In Pharmaceutical Development
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Bayesian Applications In Pharmaceutical Development


Bayesian Applications In Pharmaceutical Development
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Author : Mani Lakshminarayanan
language : en
Publisher: CRC Press
Release Date : 2019-10-10

Bayesian Applications In Pharmaceutical Development written by Mani Lakshminarayanan and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-10-10 with Mathematics categories.


The cost for bringing new medicine from discovery to market has nearly doubled in the last decade and has now reached $2.6 billion. There is an urgent need to make drug development less time-consuming and less costly. Innovative trial designs/ analyses such as the Bayesian approach are essential to meet this need. This book will be the first to provide comprehensive coverage of Bayesian applications across the span of drug development, from discovery, to clinical trial, to manufacturing with practical examples. This book will have a wide appeal to statisticians, scientists, and physicians working in drug development who are motivated to accelerate and streamline the drug development process, as well as students who aspire to work in this field. The advantages of this book are: Provides motivating, worked, practical case examples with easy to grasp models, technical details, and computational codes to run the analyses Balances practical examples with best practices on trial simulation and reporting, as well as regulatory perspectives Chapters written by authors who are individual contributors in their respective topics Dr. Mani Lakshminarayanan is a researcher and statistical consultant with more than 30 years of experience in the pharmaceutical industry. He has published over 50 articles, technical reports, and book chapters besides serving as a referee for several journals. He has a PhD in Statistics from Southern Methodist University, Dallas, Texas and is a Fellow of the American Statistical Association. Dr. Fanni Natanegara has over 15 years of pharmaceutical experience and is currently Principal Research Scientist and Group Leader for the Early Phase Neuroscience Statistics team at Eli Lilly and Company. She played a key role in the Advanced Analytics team to provide Bayesian education and statistical consultation at Eli Lilly. Dr. Natanegara is the chair of the cross industry-regulatory-academic DIA BSWG to ensure that Bayesian methods are appropriately utilized for design and analysis throughout the drug-development process.

Bayesian Applications In Pharmaceutical Development


Bayesian Applications In Pharmaceutical Development
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Author : Taylor & Francis Group
language : en
Publisher: CRC Press
Release Date : 2021-09-30

Bayesian Applications In Pharmaceutical Development written by Taylor & Francis Group and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-09-30 with categories.


This provides comprehensive coverage of Bayesian application across the span of drug development from discovery to clinical trial to manufacturing with practical examples as illustration.

Bayesian Methods In Pharmaceutical Research


Bayesian Methods In Pharmaceutical Research
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Author : Emmanuel Lesaffre
language : en
Publisher: CRC Press
Release Date : 2020-04-28

Bayesian Methods In Pharmaceutical Research written by Emmanuel Lesaffre and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-04-28 with Medical categories.


Since the early 2000s, there has been increasing interest within the pharmaceutical industry in the application of Bayesian methods at various stages of the research, development, manufacturing, and health economic evaluation of new health care interventions. In 2010, the first Applied Bayesian Biostatistics conference was held, with the primary objective to stimulate the practical implementation of Bayesian statistics, and to promote the added-value for accelerating the discovery and the delivery of new cures to patients. This book is a synthesis of the conferences and debates, providing an overview of Bayesian methods applied to nearly all stages of research and development, from early discovery to portfolio management. It highlights the value associated with sharing a vision with the regulatory authorities, academia, and pharmaceutical industry, with a view to setting up a common strategy for the appropriate use of Bayesian statistics for the benefit of patients. The book covers: Theory, methods, applications, and computing Bayesian biostatistics for clinical innovative designs Adding value with Real World Evidence Opportunities for rare, orphan diseases, and pediatric development Applied Bayesian biostatistics in manufacturing Decision making and Portfolio management Regulatory perspective and public health policies Statisticians and data scientists involved in the research, development, and approval of new cures will be inspired by the possible applications of Bayesian methods covered in the book. The methods, applications, and computational guidance will enable the reader to apply Bayesian methods in their own pharmaceutical research. Emmanuel Lesaffre is Professor of Biostatistics at KU Leuven, Belgium. Gianluca Baio is Professor of Statistics and Health Economics at University College London, UK. Bruno Boulanger is Chief Scientific Officer at PharmaLex, Belgium.

Bayesian Analysis With R For Drug Development


Bayesian Analysis With R For Drug Development
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Author : Harry Yang
language : en
Publisher: CRC Press
Release Date : 2019-07-09

Bayesian Analysis With R For 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 2019-07-09 with Mathematics categories.


Drug development is an iterative process. The recent publications of regulatory guidelines further entail a lifecycle approach. Blending data from disparate sources, the Bayesian approach provides a flexible framework for drug development. Despite its advantages, the uptake of Bayesian methodologies is lagging behind in the field of pharmaceutical development. Written specifically for pharmaceutical practitioners, Bayesian Analysis with R for Drug Development: Concepts, Algorithms, and Case Studies, describes a wide range of Bayesian applications to problems throughout pre-clinical, clinical, and Chemistry, Manufacturing, and Control (CMC) development. Authored by two seasoned statisticians in the pharmaceutical industry, the book provides detailed Bayesian solutions to a broad array of pharmaceutical problems. Features Provides a single source of information on Bayesian statistics for drug development Covers a wide spectrum of pre-clinical, clinical, and CMC topics Demonstrates proper Bayesian applications using real-life examples Includes easy-to-follow R code with Bayesian Markov Chain Monte Carlo performed in both JAGS and Stan Bayesian software platforms Offers sufficient background for each problem and detailed description of solutions suitable for practitioners with limited Bayesian knowledge Harry Yang, Ph.D., is Senior Director and Head of Statistical Sciences at AstraZeneca. He has 24 years of experience across all aspects of drug research and development and extensive global regulatory experiences. He has published 6 statistical books, 15 book chapters, and over 90 peer-reviewed papers on diverse scientific and statistical subjects, including 15 joint statistical works with Dr. Novick. He is a frequent invited speaker at national and international conferences. He also developed statistical courses and conducted training at the FDA and USP as well as Peking University. Steven Novick, Ph.D., is Director of Statistical Sciences at AstraZeneca. He has extensively contributed statistical methods to the biopharmaceutical literature. Novick is a skilled Bayesian computer programmer and is frequently invited to speak at conferences, having developed and taught courses in several areas, including drug-combination analysis and Bayesian methods in clinical areas. Novick served on IPAC-RS and has chaired several national statistical conferences.

Bayesian Analysis With R For Drug Development


Bayesian Analysis With R For Drug Development
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Author : Harry Yang
language : en
Publisher: CRC Press
Release Date : 2019-06-26

Bayesian Analysis With R For 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 2019-06-26 with Mathematics categories.


Drug development is an iterative process. The recent publications of regulatory guidelines further entail a lifecycle approach. Blending data from disparate sources, the Bayesian approach provides a flexible framework for drug development. Despite its advantages, the uptake of Bayesian methodologies is lagging behind in the field of pharmaceutical development. Written specifically for pharmaceutical practitioners, Bayesian Analysis with R for Drug Development: Concepts, Algorithms, and Case Studies, describes a wide range of Bayesian applications to problems throughout pre-clinical, clinical, and Chemistry, Manufacturing, and Control (CMC) development. Authored by two seasoned statisticians in the pharmaceutical industry, the book provides detailed Bayesian solutions to a broad array of pharmaceutical problems. Features Provides a single source of information on Bayesian statistics for drug development Covers a wide spectrum of pre-clinical, clinical, and CMC topics Demonstrates proper Bayesian applications using real-life examples Includes easy-to-follow R code with Bayesian Markov Chain Monte Carlo performed in both JAGS and Stan Bayesian software platforms Offers sufficient background for each problem and detailed description of solutions suitable for practitioners with limited Bayesian knowledge Harry Yang, Ph.D., is Senior Director and Head of Statistical Sciences at AstraZeneca. He has 24 years of experience across all aspects of drug research and development and extensive global regulatory experiences. He has published 6 statistical books, 15 book chapters, and over 90 peer-reviewed papers on diverse scientific and statistical subjects, including 15 joint statistical works with Dr. Novick. He is a frequent invited speaker at national and international conferences. He also developed statistical courses and conducted training at the FDA and USP as well as Peking University. Steven Novick, Ph.D., is Director of Statistical Sciences at AstraZeneca. He has extensively contributed statistical methods to the biopharmaceutical literature. Novick is a skilled Bayesian computer programmer and is frequently invited to speak at conferences, having developed and taught courses in several areas, including drug-combination analysis and Bayesian methods in clinical areas. Novick served on IPAC-RS and has chaired several national statistical conferences.

Bayesian Adaptive Methods For Clinical Trials


Bayesian Adaptive Methods For Clinical Trials
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Author : Scott M. Berry
language : en
Publisher: CRC Press
Release Date : 2010-07-19

Bayesian Adaptive Methods For Clinical Trials written by Scott M. Berry and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-07-19 with Mathematics categories.


Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer’s disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, Bayesian Adaptive Methods for Clinical Trials explores the growing role of Bayesian thinking in the rapidly changing world of clinical trial analysis. The book first summarizes the current state of clinical trial design and analysis and introduces the main ideas and potential benefits of a Bayesian alternative. It then gives an overview of basic Bayesian methodological and computational tools needed for Bayesian clinical trials. With a focus on Bayesian designs that achieve good power and Type I error, the next chapters present Bayesian tools useful in early (Phase I) and middle (Phase II) clinical trials as well as two recent Bayesian adaptive Phase II studies: the BATTLE and ISPY-2 trials. In the following chapter on late (Phase III) studies, the authors emphasize modern adaptive methods and seamless Phase II–III trials for maximizing information usage and minimizing trial duration. They also describe a case study of a recently approved medical device to treat atrial fibrillation. The concluding chapter covers key special topics, such as the proper use of historical data, equivalence studies, and subgroup analysis. For readers involved in clinical trials research, this book significantly updates and expands their statistical toolkits. The authors provide many detailed examples drawing on real data sets. The R and WinBUGS codes used throughout are available on supporting websites. Scott Berry talks about the book on the CRC Press YouTube Channel.

Real World Evidence In Drug Development And Evaluation


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