Case Studies In Bayesian Methods For Biopharmaceutical Cmc

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Case Studies in Bayesian Methods for Biopharmaceutical CMC

Author : Paul Faya
Publisher : CRC Press
ISBN 13 : 1000824772
Total Pages : 354 pages
Book Rating : 4.0/5 (8 download)

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Book Synopsis Case Studies in Bayesian Methods for Biopharmaceutical CMC by : Paul Faya

Download or read book Case Studies in Bayesian Methods for Biopharmaceutical CMC written by Paul Faya and published by CRC Press. This book was released on 2022-12-15 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: The subject of this book is applied Bayesian methods for chemistry, manufacturing, and control (CMC) studies in the biopharmaceutical industry. The book has multiple authors from industry and academia, each contributing a case study (chapter). The collection of case studies covers a broad array of CMC topics, including stability analysis, analytical method development, specification setting, process development and optimization, process control, experimental design, dissolution testing, and comparability studies. The analysis of each case study includes a presentation of code and reproducible output. This book is written with an academic level aimed at practicing nonclinical biostatisticians, most of whom have graduate degrees in statistics. • First book of its kind focusing strictly on CMC Bayesian case studies • Case studies with code and output • Representation from several companies across the industry as well as academia • Authors are leading and well-known Bayesian statisticians in the CMC field • Accompanying website with code for reproducibility • Reflective of real-life industry applications/problems

Bayesian Analysis with R for Drug Development

Author : Harry Yang
Publisher : CRC Press
ISBN 13 : 1351585940
Total Pages : 310 pages
Book Rating : 4.3/5 (515 download)

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Book Synopsis Bayesian Analysis with R for Drug Development by : Harry Yang

Download or read book Bayesian Analysis with R for Drug Development written by Harry Yang and published by CRC Press. This book was released on 2019-06-26 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Case studies in bayesian statistics

Author : Constantine Gatsonis
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (874 download)

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Book Synopsis Case studies in bayesian statistics by : Constantine Gatsonis

Download or read book Case studies in bayesian statistics written by Constantine Gatsonis and published by . This book was released on 1995 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Case Studies in Innovative Clinical Trials

Author : Kristine Broglio
Publisher : CRC Press
ISBN 13 : 1000987213
Total Pages : 303 pages
Book Rating : 4.0/5 (9 download)

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Book Synopsis Case Studies in Innovative Clinical Trials by : Kristine Broglio

Download or read book Case Studies in Innovative Clinical Trials written by Kristine Broglio and published by CRC Press. This book was released on 2023-11-27 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Bayesian Precision Medicine

Author : Peter F. Thall
Publisher : CRC Press
ISBN 13 : 1040026664
Total Pages : 330 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Bayesian Precision Medicine by : Peter F. Thall

Download or read book Bayesian Precision Medicine written by Peter F. Thall and published by CRC Press. This book was released on 2024-05-07 with total page 330 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bayesian Precision Medicine presents modern Bayesian statistical models and methods for identifying treatments tailored to individual patients using their prognostic variables and predictive biomarkers. The process of evaluating and comparing treatments is explained and illustrated by practical examples, followed by a discussion of causal analysis and its relationship to statistical inference. A wide array of modern Bayesian clinical trial designs are presented, including applications to many oncology trials. The later chapters describe Bayesian nonparametric regression analyses of datasets arising from multistage chemotherapy for acute leukemia, allogeneic stem cell transplantation, and targeted agents for treating advanced breast cancer. Features: Describes the connection between causal analysis and statistical inference Reviews modern personalized Bayesian clinical trial designs for dose-finding, treatment screening, basket trials, enrichment, incorporating historical data, and confirmatory treatment comparison, illustrated by real-world applications Presents adaptive methods for clustering similar patient subgroups to improve efficiency Describes Bayesian nonparametric regression analyses of real-world datasets from oncology Provides pointers to software for implementation Bayesian Precision Medicine is primarily aimed at biostatisticians and medical researchers who desire to apply modern Bayesian methods to their own clinical trials and data analyses. It also might be used to teach a special topics course on precision medicine using a Bayesian approach to postgraduate biostatistics students. The main goal of the book is to show how Bayesian thinking can provide a practical scientific basis for tailoring treatments to individual patients.

Case Studies in Bayesian Statistics

Author : Constantine Gatsonis
Publisher : Springer
ISBN 13 :
Total Pages : 464 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Case Studies in Bayesian Statistics by : Constantine Gatsonis

Download or read book Case Studies in Bayesian Statistics written by Constantine Gatsonis and published by Springer. This book was released on 2002 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: The series of workshops Case Studies in Bayesian Statistics at Carnegie Mellon University is unique in devoting an entire meeting to extended presentation and discussion of scientific investigations in which statisticians play central roles within integrated, cross- disciplinary teams. The goal has been to elucidate the interplay between Bayesian theory and practice, and thereby identify successful methods and indicate important directions for future research. This volume contains the four invited case studies, with accompanying discussion, and nine contributed papers, from the 4th workshop, which was held September 27-28, 1997. While most of the case studies in this volume come from biomedical research, the reader will also find studies in environmental science and marketing research. Students and teachers of statistics, research statisticians, and investigators from other fields should find a wealth of ideas and methods in this series of case studies.

Statistical Methods for Dynamic Disease Screening and Spatio-Temporal Disease Surveillance

Author : Peihua Qiu
Publisher : CRC Press
ISBN 13 : 1040026737
Total Pages : 370 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Statistical Methods for Dynamic Disease Screening and Spatio-Temporal Disease Surveillance by : Peihua Qiu

Download or read book Statistical Methods for Dynamic Disease Screening and Spatio-Temporal Disease Surveillance written by Peihua Qiu and published by CRC Press. This book was released on 2024-06-18 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: Disease screening and disease surveillance (DSDS) constitute two critical areas in public health, each presenting distinctive challenges primarily due to their sequential decision-making nature and complex data structures. Statistical Methods for Dynamic Disease Screening and Spatio-Temporal Disease Surveillance explores numerous recent analytic methodologies that enhance traditional techniques. The author, a prominent researcher specializing in innovative sequential decision-making techniques, demonstrates how these novel methods effectively address the challenges of DSDS. After a concise introduction that lays the groundwork for comprehending the challenges inherent in DSDS, the book delves into fundamental statistical concepts and methods relevant to DSDS. This includes exploration of statistical process control (SPC) charts specifically crafted for sequential decision-making purposes. The subsequent chapters systematically outline recent advancements in dynamic screening system (DySS) methods, fine-tuned for effective disease screening. Additionally, the text covers both traditional and contemporary analytic methods for disease surveillance. It further introduces two recently developed R packages designed for implementing DySS methods and spatio-temporal disease surveillance techniques pioneered by the author's research team. Features • Presents Recent Analytic Methods for DSDS: The book introduces analytic methods for DSDS based on SPC charts. These methods effectively utilize all historical data, accommodating the complex data structure inherent in sequential decision-making processes. • Introduces Recent R Packages: Two recent R packages, DySS and SpTe2M, are introduced. The book not only presents these packages but also demonstrates key DSDS methods using them. • Examines Recent Research Results: The text delves into the latest research findings across various domains, including dynamic disease screening, nonparametric spatio-temporal data modeling and monitoring, and spatio-temporal disease surveillance. • Accessible Description of Methods: Major methods are described in a manner accessible to individuals without advanced knowledge in mathematics and statistics. The goal is to facilitate a clear understanding of ideas and easy implementation. • Real-Data Examples: To aid comprehension, the book provides several real-data examples illustrating key concepts and methods. • Hands-on Exercises: Each chapter includes exercises to encourage hands-on practice, allowing readers to engage directly with the presented methods.

Design and Analysis of Pragmatic Trials

Author : Song Zhang
Publisher : CRC Press
ISBN 13 : 1000873552
Total Pages : 215 pages
Book Rating : 4.0/5 (8 download)

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Book Synopsis Design and Analysis of Pragmatic Trials by : Song Zhang

Download or read book Design and Analysis of Pragmatic Trials written by Song Zhang and published by CRC Press. This book was released on 2023-05-16 with total page 215 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book begins with an introduction of pragmatic cluster randomized trials (PCTs) and reviews various pragmatic issues that need to be addressed by statisticians at the design stage. It discusses the advantages and disadvantages of each type of PCT, and provides sample size formulas, sensitivity analyses, and examples for sample size calculation. The generalized estimating equation (GEE) method will be employed to derive sample size formulas for various types of outcomes from the exponential family, including continuous, binary, and count variables. Experimental designs that have been frequently employed in PCTs will be discussed, including cluster randomized designs, matched-pair cluster randomized design, stratified cluster randomized design, stepped-wedge cluster randomized design, longitudinal cluster randomized design, and crossover cluster randomized design. It demonstrates that the GEE approach is flexible to accommodate pragmatic issues such as hierarchical correlation structures, different missing data patterns, randomly varying cluster sizes, etc. It has been reported that the GEE approach leads to under-estimated variance with limited numbers of clusters. The remedy for this limitation is investigated for the design of PCTs. This book can assist practitioners in the design of PCTs by providing a description of the advantages and disadvantages of various PCTs and sample size formulas that address various pragmatic issues, facilitating the proper implementation of PCTs to improve health care. It can also serve as a textbook for biostatistics students at the graduate level to enhance their knowledge or skill in clinical trial design. Key Features: Discuss the advantages and disadvantages of each type of PCTs, and provide sample size formulas, sensitivity analyses, and examples. Address an unmet need for guidance books on sample size calculations for PCTs; A wide variety of experimental designs adopted by PCTs are covered; The sample size solutions can be readily implemented due to the accommodation of common pragmatic issues encountered in real-world practice; Useful to both academic and industrial biostatisticians involved in clinical trial design; Can be used as a textbook for graduate students majoring in statistics and biostatistics.

Controlled Epidemiological Studies

Author : Marie Reilly
Publisher : CRC Press
ISBN 13 : 0429590741
Total Pages : 472 pages
Book Rating : 4.4/5 (295 download)

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Book Synopsis Controlled Epidemiological Studies by : Marie Reilly

Download or read book Controlled Epidemiological Studies written by Marie Reilly and published by CRC Press. This book was released on 2023-05-26 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers classic epidemiological designs that use a reference/control group, including case-control, case-cohort, nested case-control and variations of these designs, such as stratified and two-stage designs. It presents a unified view of these sampling designs as representations of an underlying cohort or target population of interest. This enables various extended designs to be introduced and analysed with a similar approach: extreme sampling on the outcome (extreme case-control design) or on the exposure (exposure-enriched, exposure-density, countermatched), designs that re-use prior controls and augmentation sampling designs. Further extensions exploit aggregate data for efficient cluster sampling, accommodate time-varying exposures and combine matched and unmatched controls. Self-controlled designs, including case-crossover, self-controlled case series and exposure-crossover, are also presented. The test-negative design for vaccine studies and the use of negative controls for bias assessment are introduced and discussed. This book is intended for graduate students in biostatistics, epidemiology and related disciplines, or for health researchers and data analysts interested in extending their knowledge of study design and data analysis skills. This book Bridges the gap between epidemiology and the more mathematically oriented biostatistics books. Assembles the wealth of epidemiological knowledge about observational study designs that is scattered over several decades of scientific publications. Illustrates the performance of methods in real research applications. Provides guidelines for implementation in standard software packages (Stata, R). Includes numerous exercises, covering simple mathematical proofs, consideration of proposed or published designs, and practical data analysis.

Development of Gene Therapies

Author : Avery McIntosh
Publisher : CRC Press
ISBN 13 : 1003855962
Total Pages : 490 pages
Book Rating : 4.0/5 (38 download)

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Book Synopsis Development of Gene Therapies by : Avery McIntosh

Download or read book Development of Gene Therapies written by Avery McIntosh and published by CRC Press. This book was released on 2024-05-23 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cell and gene therapies have become the third major drug modality in pharmaceutical medicine of the 21st century after low molecular weight and antibody drugs. The gene therapy (GTx) field is rapidly advancing, and yet there are still fundamental scientific questions that remain to be answered. Development of GTx products poses unique challenges and opportunities for drug developers. However, there is lack of a systematic exposition of the GTx product development and the pivotal role of the biostatistician in this process. Development of Gene Therapies: Strategic, Scientific, and Regulatory, and Access Considerations attempts to summarize the current state-of-the-art strategic, scientific, statistical, and regulatory aspects of GTx development. Intended to provide an exposition to the GTx new product development through peer-reviewed papers written by subject matter experts in this emerging field, this book will be useful for researchers in gene therapy drug development, biostatisticians, regulators, patient advocates, graduate students, and the finance and business development community . Key Features: A collection of papers covering a wide spectrum of topics in gene therapies (GTx), written by leading subject matter experts An exposition of the core principles of GTx product development, emerging business models, industry standards, best practices, and regulatory pathways An exposition of statistical and innovative modeling tools for design and analysis of clinical trials of GTx Insights into commercial models, access hurdles, and health economics of gene therapies Case studies of successful GTx approvals from core team members that developed the first two FDA-approved AAV gene therapies: Luxturna and Zolgensma A discussion of potential benefits and hurdles to be overcome for GTx in coming years from a multi-stakeholder perspective

Value of Information for Healthcare Decision-Making

Author : Anna Heath
Publisher : CRC Press
ISBN 13 : 1003825575
Total Pages : 317 pages
Book Rating : 4.0/5 (38 download)

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Book Synopsis Value of Information for Healthcare Decision-Making by : Anna Heath

Download or read book Value of Information for Healthcare Decision-Making written by Anna Heath and published by CRC Press. This book was released on 2024-02-08 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: Value of Information for Healthcare Decision-Making introduces the concept of Value of Information (VOI) use in health policy decision-making to determine the sensitivity of decisions to assumptions, and to prioritise and design future research. These methods, and their use in cost-effectiveness analysis, are increasingly acknowledged by health technology assessment authorities as vital. Key Features: Provides a comprehensive overview of VOI Simplifies VOI Showcases state-of-the-art techniques for computing VOI Includes R statistical software package Provides results when using VOI methods Uses realistic decision model to illustrate key concepts The primary audience for this book is health economic modellers and researchers, in industry, government, or academia, who wish to perform VOI analysis in health economic evaluations. It is relevant for postgraduate researchers and students in health economics or medical statistics who are required to learn the principles of VOI or undertake VOI analyses in their projects. The overall goal is to improve the understanding of these methods and make them easier to use.

Digital Therapeutics

Author : Oleksandr Sverdlov
Publisher : CRC Press
ISBN 13 : 1000799239
Total Pages : 462 pages
Book Rating : 4.0/5 (7 download)

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Book Synopsis Digital Therapeutics by : Oleksandr Sverdlov

Download or read book Digital Therapeutics written by Oleksandr Sverdlov and published by CRC Press. This book was released on 2022-12-06 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt: One of the hallmarks of the 21st century medicine is the emergence of digital therapeutics (DTx)—evidence-based, clinically validated digital technologies to prevent, diagnose, treat, and manage various diseases and medical conditions. DTx solutions have been gaining interest from patients, investors, healthcare providers, health authorities, and other stakeholders because of the potential of DTx to deliver equitable, massively scalable, personalized and transformative treatments for different unmet medical needs. Digital Therapeutics: Scientific, Statistical, Clinical, and Regulatory Aspects is an unparalleled summary of the current scientific, statistical, developmental, and regulatory aspects of DTx which is poised to become the fastest growing area of the biopharmaceutical and digital medicine product development. This edited volume intends to provide a systematic exposition to digital therapeutics through 19 peer-reviewed chapters written by subject matter experts in this emerging field. This edited volume is an invaluable resource for business leaders and researchers working in public health, healthcare, digital health, information technology, and biopharmaceutical industries. It will be also useful for regulatory scientists involved in the review of DTx products, and for faculty and students involved in an interdisciplinary research on digital health and digital medicine. Key Features: Provides the taxonomy of the concepts and a navigation tool for the field of DTx. Covers important strategic aspects of the DTx industry, thereby helping investors, developers, and regulators gain a better appreciation of the potential value of DTx. Expounds on many existing and emerging state-of-the art scientific and technological tools, as well as data privacy, ethical and regulatory considerations for DTx product development. Presents several case studies of successful development of some of the most remarkable DTx products. Provides some perspectives and forward-looking statements on the future of digital medicine.

ROC Analysis for Classification and Prediction in Practice

Author : Christos Nakas
Publisher : CRC Press
ISBN 13 : 1482233711
Total Pages : 234 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis ROC Analysis for Classification and Prediction in Practice by : Christos Nakas

Download or read book ROC Analysis for Classification and Prediction in Practice written by Christos Nakas and published by CRC Press. This book was released on 2023-05-15 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents a unified and up-to-date introduction to ROC methodologies, covering both diagnosis (classification) and prediction. The emphasis is on the conceptual underpinning of ROC analysis and the practical implementation in diverse scientific fields. A plethora of examples accompany the methodologic discussion using standard statistical software such as R and STATA. The book arrives after two decades of intensive growth in both the methods and the applications of ROC analysis and presents a new synthesis. The authors provide a contemporary, integrated exposition of ROC methodology for both classification and prediction and include material on multiple-class ROC. This book avoids lengthy technical exposition and provides code and datasets in each chapter. Receiver Operating Characteristic Analysis for Classification and Prediction is intended for researchers and graduate students, but will also be useful for those that use ROC analysis in diverse disciplines such as diagnostic medicine, bioinformatics, medical physics, and perception psychology.

Statistical Methods in Health Disparity Research

Author : J. Sunil Rao
Publisher : CRC Press
ISBN 13 : 1000905098
Total Pages : 298 pages
Book Rating : 4.0/5 (9 download)

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Book Synopsis Statistical Methods in Health Disparity Research by : J. Sunil Rao

Download or read book Statistical Methods in Health Disparity Research written by J. Sunil Rao and published by CRC Press. This book was released on 2023-07-11 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: • Presents an overview of methods and applications of health disparity estimation • First book to synthesize research in this field in a unified statistical framework • Covers classical approaches, and builds to more modern computational techniques • Includes many worked examples and case studies using real data • Discusses available software for estimation

Statistical Analytics for Health Data Science with SAS and R

Author : Jeffrey Wilson
Publisher : CRC Press
ISBN 13 : 1000848825
Total Pages : 280 pages
Book Rating : 4.0/5 (8 download)

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Book Synopsis Statistical Analytics for Health Data Science with SAS and R by : Jeffrey Wilson

Download or read book Statistical Analytics for Health Data Science with SAS and R written by Jeffrey Wilson and published by CRC Press. This book was released on 2023-03-27 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book aims to compile typical fundamental-to-advanced statistical methods to be used for health data sciences. Although the book promotes applications to health and health-related data, the models in the book can be used to analyze any kind of data. The data are analyzed with the commonly used statistical software of R/SAS (with online supplementary on SPSS/Stata). The data and computing programs will be available to facilitate readers’ learning experience. There has been considerable attention to making statistical methods and analytics available to health data science researchers and students. This book brings it all together to provide a concise point-of-reference for the most commonly used statistical methods from the fundamental level to the advanced level. We envisage this book will contribute to the rapid development in health data science. We provide straightforward explanations of the collected statistical theory and models, compilations of a variety of publicly available data, and illustrations of data analytics using commonly used statistical software of SAS/R. We will have the data and computer programs available for readers to replicate and implement the new methods. The primary readers would be applied data scientists and practitioners in any field of data science, applied statistical analysts and scientists in public health, academic researchers, and graduate students in statistics and biostatistics. The secondary readers would be R&D professionals/practitioners in industry and governmental agencies. This book can be used for both teaching and applied research.

Probability Modeling and Statistical Inference in Cancer Screening

Author : Dongfeng Wu
Publisher : CRC Press
ISBN 13 : 1003844944
Total Pages : 286 pages
Book Rating : 4.0/5 (38 download)

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Book Synopsis Probability Modeling and Statistical Inference in Cancer Screening by : Dongfeng Wu

Download or read book Probability Modeling and Statistical Inference in Cancer Screening written by Dongfeng Wu and published by CRC Press. This book was released on 2024-02-06 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cancer screening has been carried out for six decades – however, there are many unsolved problems: how to estimate key parameters involved in screenings, such as sensitivity, the time duration in the preclinical state (i.e., sojourn time), and time duration in the disease-free state; how to estimate the distribution of lead time, the diagnosis time advanced by screening; how to evaluate the long-term outcomes of screening, including the probability of overdiagnosis among the screen-detected; when to schedule the first exam based on one’s current age and risk tolerance; and when to schedule the upcoming exam based on one’s screening history, age, and risk tolerance. These problems need proper probability models and statistical methods in order to be dealt with. Features: This book gives a concise account of the analysis of cancer screening data, using probability models and statistical methods. Real data sets are provided so that cancer researchers and statisticians can apply the methods in the learning process. It develops statistical methods in the commonly used disease progressive model. It provides solutions to practical problems and introduces open problems. It provides a framework for the most recent developments based on the author’s research. The book is primarily aimed at researchers and practitioners from biostatistics and cancer research. Readers should have the prerequisite knowledge of calculus, probability, and statistical inference. The book could be used as a one-semester textbook on the topic of cancer screening methodology for a graduate-level course.

Drug Development for Rare Diseases

Author : Bo Yang
Publisher : CRC Press
ISBN 13 : 100082022X
Total Pages : 233 pages
Book Rating : 4.0/5 (8 download)

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Book Synopsis Drug Development for Rare Diseases by : Bo Yang

Download or read book Drug Development for Rare Diseases written by Bo Yang and published by CRC Press. This book was released on 2023-01-10 with total page 233 pages. Available in PDF, EPUB and Kindle. Book excerpt: A disease is defined as rare if the prevalence is fewer than 200,000 in the United States. It is estimated that there are more than 7,000 rare diseases, which collectively affect 30 million Americans or 10% of the US population. This diverse and complex disease area poses challenges for patients, caregivers, regulators, drug developers, and other stakeholders. This book is proposed to give an overview of the common issues facing rare disease drug developers, summarize challenges specific to clinical development in small populations, discuss drug development strategies in the evolving regulatory environment, explain generation and utilization of different data and evidence inside and beyond clinical trials, and use recent examples to demonstrate these challenges and the development strategies that respond to the challenges. Key Features: • Rare disease. • Drug development. • Innovative clinical trial design. • Regulatory approval. • Real-world evidence.