Dose Finding And Beyond In Biopharmaceutical Development
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Dose Finding And Beyond In Biopharmaceutical Development
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Author : Jingjing Ye
language : en
Publisher: Springer Nature
Release Date : 2024-10-28
Dose Finding And Beyond In Biopharmaceutical Development written by Jingjing Ye and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-10-28 with Medical categories.
This book covers topics in 2 parts: 1) Review of FDA Guidance, 2) Novel Designs and Analyses. While covering basic principles of dose finding, this book details advancements made in drug development. Finding the right dose(s) is one of the most important objectives in new drug development. In Phase I clinical development, one of the objectives is to escalate test doses from low to high. The low doses should be safe, then escalate up to the maximally tolerable dose (MTD). Phase II clinical trials then lower test doses to the minimal efficacious dose (MinED). Dose range of a study drug can be thought of as the doses between MinED and MTD. From this dose range, one or a few doses are selected for Phase III confirmation. In practice, dose finding is a very difficult in every phase of clinical development for new drugs. The editors brought distinguished researchers and practitioners in biopharmaceuticals and universities, to discuss the statistical procedures, useful methods, and their novel applications in dose finding. The chapters in the book present emerging topics in dose-finding and related interdisciplinary areas. This timely book is a valuable resource to stimulate the development of this growing and exciting field in drug development.
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.
Clinical Trial Biostatistics And Biopharmaceutical Applications
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Author : Walter R. Young
language : en
Publisher: CRC Press
Release Date : 2014-11-20
Clinical Trial Biostatistics And Biopharmaceutical Applications written by Walter R. Young and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-11-20 with Mathematics categories.
Since 1945, "The Annual Deming Conference on Applied Statistics" has been an important event in the statistics profession. In Clinical Trial Biostatistics and Biopharmaceutical Applications, prominent speakers from past Deming conferences present novel biostatistical methodologies in clinical trials as well as up-to-date biostatistical applications from the pharmaceutical industry. Divided into five sections, the book begins with emerging issues in clinical trial design and analysis, including the roles of modeling and simulation, the pros and cons of randomization procedures, the design of Phase II dose-ranging trials, thorough QT/QTc clinical trials, and assay sensitivity and the constancy assumption in noninferiority trials. The second section examines adaptive designs in drug development, discusses the consequences of group-sequential and adaptive designs, and illustrates group sequential design in R. The third section focuses on oncology clinical trials, covering competing risks, escalation with overdose control (EWOC) dose finding, and interval-censored time-to-event data. In the fourth section, the book describes multiple test problems with applications to adaptive designs, graphical approaches to multiple testing, the estimation of simultaneous confidence intervals for multiple comparisons, and weighted parametric multiple testing methods. The final section discusses the statistical analysis of biomarkers from omics technologies, biomarker strategies applicable to clinical development, and the statistical evaluation of surrogate endpoints. This book clarifies important issues when designing and analyzing clinical trials, including several misunderstood and unresolved challenges. It will help readers choose the right method for their biostatistical application. Each chapter is self-contained with references.
Encyclopedia Of Biopharmaceutical Statistics Four Volume Set
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2018-09-03
Encyclopedia Of Biopharmaceutical Statistics Four Volume Set written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-09-03 with Medical categories.
Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.
Analysis Of Clinical Trials Using Sas
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Author : Alex Dmitrienko
language : en
Publisher: SAS Institute
Release Date : 2017-07-17
Analysis Of Clinical Trials Using Sas written by Alex Dmitrienko and has been published by SAS Institute this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-07-17 with Computers categories.
Analysis of Clinical Trials Using SAS®: A Practical Guide, Second Edition bridges the gap between modern statistical methodology and real-world clinical trial applications. Tutorial material and step-by-step instructions illustrated with examples from actual trials serve to define relevant statistical approaches, describe their clinical trial applications, and implement the approaches rapidly and efficiently using the power of SAS. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials. Commonly used methods are covered, including dose-escalation and dose-finding methods that are applied in Phase I and Phase II clinical trials, as well as important trial designs and analysis strategies that are employed in Phase II and Phase III clinical trials, such as multiplicity adjustment, data monitoring, and methods for handling incomplete data. This book also features recommendations from clinical trial experts and a discussion of relevant regulatory guidelines. This new edition includes more examples and case studies, new approaches for addressing statistical problems, and the following new technological updates: SAS procedures used in group sequential trials (PROC SEQDESIGN and PROC SEQTEST) SAS procedures used in repeated measures analysis (PROC GLIMMIX and PROC GEE) macros for implementing a broad range of randomization-based methods in clinical trials, performing complex multiplicity adjustments, and investigating the design and analysis of early phase trials (Phase I dose-escalation trials and Phase II dose-finding trials) Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience and the ready-to-use SAS macros compiled in this book.
Redefining Innovation
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Author : Ruchin Kansal
language : en
Publisher: Taylor & Francis
Release Date : 2018-05-11
Redefining Innovation written by Ruchin Kansal and has been published by Taylor & Francis this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-05-11 with Medical categories.
Most people marvel at the level of innovation demonstrated by the biopharmaceutical industry in bringing new products to the market – especially in the past 20 years. However, there is a crisis looming in the industry that should be a concern to all of us who take for granted the constant pace at which new treatments, and increasingly cures, have emerged from the laboratories of current sector incumbents. In the book, we examine the evolution of the biopharmaceutical industry to understand how it became what we term a "unicorn industry" with a unique, US-centered business model that has led to multiple blockbuster products (aka, unicorns) year after year. We explore how past success has created perceived barriers to innovation diversification beyond the chemical or biological-based biopharmaceutical product, and highlight the warning signs of the industry’s decline. We define a potential pathway for transforming the industry’s business model by broadening the definition, sources, and enablers of innovation beyond the traditional biopharmaceutical product. We introduce and advocate for the 80-80 Rule - "Being 80% confident that you will only be 80% right the first time should feel normal." The 80-80 Rule is a theme that emphasizes speed and willingness to embrace uncertainty and overcome internal barriers to change. It sets the standard for redefining innovation as a platform to reignite growth of the biopharmaceutical industry.
The Role Of Nih In Drug Development Innovation And Its Impact On Patient Access
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2020-01-27
The Role Of Nih In Drug Development Innovation And Its Impact On Patient Access 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 2020-01-27 with Medical categories.
To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
The Drug Development Paradigm In Oncology
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2018-02-12
The Drug Development Paradigm In Oncology 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 2018-02-12 with Medical categories.
Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.
A Guide To Sample Size For Animal Based Studies
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Author : Penny S. Reynolds
language : en
Publisher: John Wiley & Sons
Release Date : 2023-08-29
A Guide To Sample Size For Animal Based Studies written by Penny S. Reynolds 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 2023-08-29 with Medical categories.
A Guide to Sample Size for Animal-based Studies Understand a foundational area of experimental design with this innovative reference Animal-based research is an essential part of basic and preclinical research, but poses a unique set of experimental design challenges. The most important of these are the 3Rs − Replacement, Reduction and Refinement − the principles comprising the ethical framework for humane animal-based studies. However, many researchers have difficulty navigating the design trade-offs necessary to simultaneously minimize animal use, and produce scientific information that is both rigorous and reliable. A Guide to Sample Size for Animal-based Studies meets this need with a thorough, accessible reference work to the subject. This book provides a straightforward systematic approach to “rightsizing” animal-based experiments, with sample size estimates based on the fundamentals of statistical thinking: structured research questions, variation control and appropriate design of experiments. The result is a much-needed guide to planning animal-based experiments to ensure scientifically valid and reliable results. This book offers: Step-by-step guidance in diverse methods for approximating and refining sample size Detailed treatment of research topics specific to animal-based research, including pilot, feasibility and proof-of-concept studies Sample size approximation methods for different types of data − binary, continuous, ordinal, time to event − and different study types − description, comparison, nested designs, reference interval construction and dose-response studies Numerous worked examples, using real data from published papers, together with SAS and R code A Guide to Sample Size for Animal-based Studies is a must-have reference for preclinical and veterinary researchers, as well as ethical oversight committees and policymakers.
Cancer Clinical Trials
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Author : Stephen L. George
language : en
Publisher: CRC Press
Release Date : 2016-08-19
Cancer Clinical Trials written by Stephen L. George and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-08-19 with Mathematics categories.
Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials. The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of the issues addressed are also important for clinical trials in other settings. After discussing general topics, the book focuses on aspects of early and late phase clinical trials. It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes.