Quantitative Decisions In Drug Development

DOWNLOAD

Download Quantitative Decisions In Drug Development PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Quantitative Decisions In Drug Development book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page

Quantitative Decisions In Drug Development

DOWNLOAD
Author : Christy Chuang-Stein
language : en
Publisher: Springer Nature
Release Date : 2021-09-03

Quantitative Decisions In Drug Development written by Christy Chuang-Stein and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-09-03 with Mathematics categories.

This book focuses on important decision points and evidence needed for making decisions at these points during the development of a new drug. It takes a holistic approach towards drug development by incorporating explicitly knowledge learned from the earlier part of the development and available historical information into decisions at later stages. In addition, the book shares lessons learned from several select examples published in the literature since the publication of the first edition. The second edition reiterates the need for making evidence-based Go/No Go decisions in drug development discussed in the first edition. It substantially expands several topics that have seen great advances since the publication of the first edition. The most noticeable additions include three adaptive trials conducted in recent years that offer excellent learning opportunities, the use of historical data in the design and analysis of clinical trials, and extending decision criteria to the cases when the primary endpoint is binary. The examples used to illustrate the additional materials all come from real trials with some post-trial reflections offered by the authors. The book begins with an overview of product development and regulatory approval pathways. It then discusses how to incorporate prior knowledge into study design and decision making at different stages of drug development. Prior knowledge includes information pertaining to historical controls. To assist decision making, the book discusses appropriate metrics and the formulation of go/no-go decisions for progressing a drug candidate to the next development stage. Using the concept of the positive predictive value in the field of diagnostics, the book leads readers to the assessment of the probability that an investigational product is effective given positive study outcomes. Lastly, the book points out common mistakes made by drug developers under the current drug-development paradigm. The book offers useful insights to statisticians, clinicians, regulatory affairs managers and decision-makers in the pharmaceutical industry who have a basic understanding of the drug-development process and the clinical trials conducted to support drug-marketing authorization. The authors provide software codes for select analytical approaches discussed in the book. The book includes enough technical details to allow statisticians to replicate the quantitative illustrations so that they can generate information to facilitate decision-making themselves.

Quantitative Decisions In Drug Development

DOWNLOAD
Author : Christy Chuang-Stein
language : en
Publisher: Springer
Release Date : 2017-05-25

Quantitative Decisions In Drug Development written by Christy Chuang-Stein and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-05-25 with Medical categories.

This book offers a high-level treatise of evidence-based decisions in drug development. Because of the inseparable relationship between designs and decisions, a good portion of this book is devoted to the design of clinical trials. The book begins with an overview of product development and regulatory approval pathways. It then discusses how to incorporate prior knowledge into study design and decision making at different stages of drug development. The latter include selecting appropriate metrics to formulate decisions criteria, determining go/no-go decisions for progressing a drug candidate to the next stage and predicting the effectiveness of a product. Lastly, it points out common mistakes made by drug developers under the current drug-development paradigm. The book offers useful insights to statisticians, clinicians, regulatory affairs managers and decision-makers in the pharmaceutical industry who have a basic understanding of the drug-development process and the clinical trials conducted to support drug-marketing authorization. The authors provide software codes for select analytical approaches discussed in the book. The book includes enough technical details to allow statisticians to replicate the quantitative illustrations so that they can generate information to facilitate decision-making themselves.

Handbook Of Decision Analysis

DOWNLOAD
Author : Gregory S. Parnell
language : en
Publisher: John Wiley & Sons
Release Date : 2025-06-11

Handbook Of Decision Analysis written by Gregory S. Parnell 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 2025-06-11 with Business & Economics categories.

Qualitative and quantitative techniques to apply decision analysis to real-world decision problems, supported by sound mathematics, best practices, soft skills, and more With substantive illustrations based on the authors’ personal experiences throughout, Handbook of Decision Analysis describes the philosophy, knowledge, science, and art of decision analysis. Key insights from decision analysis applications and behavioral decision analysis research are presented, and numerous decision analysis textbooks, technical books, and research papers are referenced for comprehensive coverage. This book does not introduce new decision analysis mathematical theory, but rather ensures the reader can understand and use the most common mathematics and best practices, allowing them to apply rigorous decision analysis with confidence. The material is supported by examples and solution steps using Microsoft Excel and includes many challenging real-world problems. Given the increase in the availability of data due to the development of products that deliver huge amounts of data, and the development of data science techniques and academic programs, a new theme of this Second Edition is the use of decision analysis techniques with big data and data analytics. Written by a team of highly qualified professionals and academics, Handbook of Decision Analysis includes information on: Behavioral decision-making insights, decision framing opportunities, collaboration with stakeholders, information assessment, and decision analysis modeling techniques Principles of value creation through designing alternatives, clear value/risk tradeoffs, and decision implementation Qualitative and quantitative techniques for each key decision analysis task, as opposed to presenting one technique for all decisions. Stakeholder analysis, decision hierarchies, and influence diagrams to frame descriptive, predictive, and prescriptive analytics decision problems to ensure implementation success Handbook of Decision Analysis is a highly valuable textbook, reference, and/or refresher for students and decision professionals in business, management science, engineering, engineering management, operations management, mathematics, and statistics who want to increase the breadth and depth of their technical and soft skills for success when faced with a professional or personal decision.

Optimization Of Pharmaceutical R D Programs And Portfolios

DOWNLOAD
Author : Zoran Antonijevic
language : en
Publisher: Springer
Release Date : 2014-10-10

Optimization Of Pharmaceutical R D Programs And Portfolios written by Zoran Antonijevic and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-10-10 with Business & Economics categories.

Very little has been published on optimization of pharmaceutical portfolios. Moreover, most of published literature is coming from the commercial side, where probability of technical success (PoS) is treated as fixed, and not as a consequence of development strategy or design. In this book there is a strong focus on impact of study design on PoS and ultimately on the value of portfolio. Design options that are discussed in different chapters are dose-selection strategies, adaptive design and enrichment. Some development strategies that are discussed are indication sequencing, optimal number of programs and optimal decision criteria. This book includes chapters written by authors with very broad backgrounds including financial, clinical, statistical, decision sciences, commercial and regulatory. Many authors have long held executive positions and have been involved with decision making at a product or at a portfolio level. As such, it is expected that this book will attract a very broad audience, including decision makers in pharmaceutical R&D, commercial and financial departments. The intended audience also includes portfolio planners and managers, statisticians, decision scientists and clinicians. Early chapters describe approaches to portfolio optimization from big Pharma and Venture Capital standpoints. They have stronger focus on finances and processes. Later chapters present selected statistical and decision analysis methods for optimizing drug development programs and portfolios. Some methodological chapters are technical; however, with a few exceptions they require a relatively basic knowledge of statistics by a reader.

Model Informed Decision Making In The Preclinical Stages Of Pharmaceutical Research And Development

DOWNLOAD
Author : Rui Li
language : en
Publisher: Frontiers Media SA
Release Date : 2023-05-10

Model Informed Decision Making In The Preclinical Stages Of Pharmaceutical Research And Development written by Rui Li 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 2023-05-10 with Science categories.

Bayesian Methods In Pharmaceutical Research

DOWNLOAD
Author : Emmanuel Lesaffre
language : en
Publisher: CRC Press
Release Date : 2020-04-15

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 2020-04-15 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.

Adme Enabling Technologies In Drug Design And Development

DOWNLOAD
Author : Donglu Zhang
language : en
Publisher: John Wiley & Sons
Release Date : 2012-04-30

Adme Enabling Technologies In Drug Design And Development written by Donglu Zhang 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 2012-04-30 with Science categories.

A comprehensive guide to cutting-edge tools in ADME research The last decade has seen tremendous progress in the development of analytical techniques such as mass spectrometry and molecular biology tools, resulting in important advances in drug discovery, particularly in the area of absorption, distribution, metabolism, and excretion (ADME). ADME-Enabling Technologies in Drug Design and Development focuses on the current state of the art in the field, presenting a comprehensive review of the latest tools for generating ADME data in drug discovery. It examines the broadest possible range of available technologies, giving readers the information they need to choose the right tool for a given application, a key requisite for obtaining favorable results in a timely fashion for regulatory filings. With over thirty contributed chapters by an international team of experts, the book provides: A thorough examination of current tools, covering both electronic/mechanical technologies and biologically based ones Coverage of applications for each technology, including key parameters, optimal conditions for intended results, protocols, and case studies Detailed discussion of emerging tools and techniques, from stem cells and genetically modified animal models to imaging technologies Numerous figures and diagrams throughout the text Scientists and researchers in drug metabolism, pharmacology, medicinal chemistry, pharmaceutics, toxicology, and bioanalytical science will find ADME-Enabling Technologies in Drug Design and Development an invaluable guide to the entire drug development process, from discovery to regulatory issues.

Exploring Maternal Fetal Pharmacology Through Pbpk Modeling Approaches

DOWNLOAD
Author : André Dallmann
language : en
Publisher: Frontiers Media SA
Release Date : 2022-06-06

Exploring Maternal Fetal Pharmacology Through Pbpk Modeling Approaches written by André Dallmann 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 2022-06-06 with Science categories.

Fundamentals Of Drug Development

DOWNLOAD
Author : Jeffrey S. Barrett
language : en
Publisher: John Wiley & Sons
Release Date : 2022-07-13

Fundamentals Of Drug Development written by Jeffrey S. Barrett 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 2022-07-13 with Medical categories.

Fundamentals of DRUG DEVELOPMENT Enables readers to understand the process of pharmaceutical research, its regulatory basis, and how it fits into the global healthcare environment This book discusses how to conduct pharmaceutical research and the context for how the industry fits into global healthcare. Holistically, the well-qualified author helps readers and students of drug development appreciate the time and expense of the process. Specifically, the work identifies the emerging trends shaping the future of drug development, along with important related topics like generic drugs, data sharing, and collaboration. To aid in seamless reader comprehension, the book includes a glossary of terms and a self-assessment quiz for each chapter at the end. PowerPoint slides are also available as an online ancillary for adopting professors. Sample topics covered in the book include: Drug development and its phases Decision-making processes, drug development milestones, and compound progression metrics The various disciplines involved along with an assessment of the complexity and risks associated across the stages of development Differences in the nature and scope of development programs due to the therapeutic area of interest Associated costs and resources required Graduate students and professors teaching courses in drug development, drug discovery, pharmaceuticals, medicinal chemistry, and drug synthesis will be able to use this book as a complete resource for understanding all the complexities and nuances involved in the drug development process.

Benefit Risk Assessment In Pharmaceutical Research And Development

DOWNLOAD
Author : Andreas Sashegyi
language : en
Publisher: CRC Press
Release Date : 2013-11-27

Benefit Risk Assessment In Pharmaceutical Research And Development written by Andreas Sashegyi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-11-27 with Mathematics categories.

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.