Statistical Methods For Evaluating Safety In Medical Product Development

Statistical Methods For Evaluating Safety In Medical Product Development Book in PDF, ePub and Kindle version is available to download in english. Read online anytime anywhere directly from your device. Click on the download button below to get a free pdf file of Statistical Methods For Evaluating Safety In Medical Product Development book. This book definitely worth reading, it is an incredibly well-written.

Statistical Methods for Evaluating Safety in Medical Product Development

A. Lawrence Gould
Statistical Methods for Evaluating Safety in Medical Product Development Book PDF

Author : A. Lawrence Gould
Publisher : John Wiley & Sons
Page : 390 pages
File Size : 52,7 Mb
Release : 2015-02-23
Category : Medical
ISBN : 9781119979661

Get Book

Statistical Methods for Evaluating Safety in Medical Product Development by A. Lawrence Gould Pdf

This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. Provides a guide to statistical methods and application in medical product development Assists readers in undertaking design and analysis of experiments at various stages of product development Features case studies throughout the book, as well as, SAS and R code

Medical Product Safety Evaluation

Jie Chen,Joseph Heyse,Tze Leung Lai
Medical Product Safety Evaluation Book PDF

Author : Jie Chen,Joseph Heyse,Tze Leung Lai
Publisher : CRC Press
Page : 220 pages
File Size : 47,9 Mb
Release : 2018-09-03
Category : Mathematics
ISBN : 9781351021968

Get Book

Medical Product Safety Evaluation by Jie Chen,Joseph Heyse,Tze Leung Lai Pdf

Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. The book is designed not only for biopharmaceutical professionals, such as statisticians, safety specialists, pharmacovigilance experts, and pharmacoepidemiologists, who can use the book as self-learning materials or in short courses or training programs, but also for graduate students in statistics and biomedical data science for a one-semester course. Each chapter provides supplements and problems as more readings and exercises.

Quantitative Evaluation of Safety in Drug Development

Qi Jiang,H. Amy Xia
Quantitative Evaluation of Safety in Drug Development Book PDF

Author : Qi Jiang,H. Amy Xia
Publisher : CRC Press
Page : 386 pages
File Size : 55,7 Mb
Release : 2014-12-08
Category : Mathematics
ISBN : 9781466555457

Get Book

Quantitative Evaluation of Safety in Drug Development by Qi Jiang,H. Amy Xia Pdf

State-of-the-Art Methods for Drug Safety Assessment Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment. The book’s three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation. Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area.

Statistical Methods in Healthcare

Frederick Faltin,Ron Kenett,Fabrizio Ruggeri
Statistical Methods in Healthcare Book PDF

Author : Frederick Faltin,Ron Kenett,Fabrizio Ruggeri
Publisher : Wiley
Page : 520 pages
File Size : 52,9 Mb
Release : 2012-10-01
Category : Medical
ISBN : 0470670150

Get Book

Statistical Methods in Healthcare by Frederick Faltin,Ron Kenett,Fabrizio Ruggeri Pdf

In recent years the number of innovative medicinal products and devices submitted and approved by regulatory bodies has declined dramatically. The medical product development process is no longer able to keep pace with increasing technologies, science and innovations and the goal is to develop new scientific and technical tools and to make product development processes more efficient and effective. Statistical Methods in Healthcare focuses on the application of statistical methodologies to evaluate promising alternatives and to optimize the performance and demonstrate the effectiveness of those that warrant pursuit is critical to success. Statistical methods used in planning, delivering and monitoring health care, as well as selected statistical aspects of the development and/or production of pharmaceuticals and medical devices are also addressed. With a focus on finding solutions to these challenges, this book: Provides a comprehensive, in-depth treatment of statistical methods in healthcare, along with a reference source for practitioners and specialists in health care and drug development. Offers a broad coverage of standards and established methods through leading edge techniques. Uses an integrated, case-study based approach, with focus on applications. Looks at the use of analytical and monitoring schemes to evaluate therapeutic performance. Features the application of modern quality management systems to clinical practice, and to pharmaceutical development and production processes. Addresses the use of modern Statistical methods such as Adaptive Design, Seamless Design, Data Mining, Bayesian networks and Bootstrapping that can be applied to support the challenging new vision. Practitioners in healthcare-related professions, ranging from clinical trials to care delivery to medical device design, as well as statistical researchers in the field, will benefit from this book.

Biopharmaceutical Applied Statistics Symposium

Karl E. Peace,Ding-Geng Chen,Sandeep Menon
Biopharmaceutical Applied Statistics Symposium Book PDF

Author : Karl E. Peace,Ding-Geng Chen,Sandeep Menon
Publisher : Springer
Page : 245 pages
File Size : 51,9 Mb
Release : 2018-08-21
Category : Medical
ISBN : 9789811078262

Get Book

Biopharmaceutical Applied Statistics Symposium by Karl E. Peace,Ding-Geng Chen,Sandeep Menon Pdf

This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments – particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter. The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications. This book is the second of the 3-volume book series. The topics covered include: Statistical Approaches to the Meta-analysis of Randomized Clinical Trials, Collaborative Targeted Maximum Likelihood Estimation to Assess Causal Effects in Observational Studies, Generalized Tests in Clinical Trials, Discrete Time-to-event and Score-based Methods with Application to Composite Endpoint for Assessing Evidence of Disease Activity-Free , Imputing Missing Data Using a Surrogate Biomarker: Analyzing the Incidence of Endometrial Hyperplasia, Selected Statistical Issues in Patient-reported Outcomes, Network Meta-analysis, Detecting Safety Signals Among Adverse Events in Clinical Trials, Applied Meta-analysis Using R, Treatment of Missing Data in Comparative Effectiveness Research, Causal Estimands: A Common Language for Missing Data, Bayesian Subgroup Analysis with Examples, Statistical Methods in Diagnostic Devices, A Question-Based Approach to the Analysis of Safety Data, Analysis of Two-stage Adaptive Seamless Trial Design, and Multiplicity Problems in Clinical Trials – A Regulatory Perspective.

Statistical Approaches in Oncology Clinical Development

Satrajit Roychoudhury,Soumi Lahiri
Statistical Approaches in Oncology Clinical Development Book PDF

Author : Satrajit Roychoudhury,Soumi Lahiri
Publisher : CRC Press
Page : 243 pages
File Size : 43,5 Mb
Release : 2018-12-07
Category : Mathematics
ISBN : 9781351650472

Get Book

Statistical Approaches in Oncology Clinical Development by Satrajit Roychoudhury,Soumi Lahiri Pdf

Statistical Approaches in Oncology Clinical Development : Current Paradigm and Methodological Advancement presents an overview of statistical considerations in oncology clinical trials, both early and late phase of development. It illustrates how novel statistical methods can enrich the design and analysis of modern oncology trials. The authors include many relevant real life examples from the pharmaceutical industry and academia based on their first-hand experience. Along with relevant references, the book highlights current regulatory views. The book covers all aspects of cancer clinical trial starting from early phase development. The early part of the book covers novel phase I dose escalation design, exposure response analysis, and innovative phase II design. This includes early development strategy for cancer immunotherapy trials. The contributors also emphasized the role of biomarker and modern era of precision medicine. The second part focuses on the late stage development. This includes the application of adaptive design, safety analysis, and quality of life (QoL) data analysis. The final part discusses current regulatory perspective and challenges. Features: Covers a wide spectrum of topics related to real-life statistical challenges in oncology clinical trials. Provides a comprehensive overview of novel statistical methods to improve trial design and statistical analysis. Detailed case studies illustrate the real life applications. Satrajit Roychoudhury is a Senior Director and a member of the Statistical Research and Innovation group in Pfizer Inc. Prior to joining; he was a member of Statistical Methodology and consulting group in Novartis. He has 11 years of extensive experience in working with different phases of clinical trial. His area of research includes early phase oncology trials, survival analysis, model informed drug development, and use of Bayesian methods in clinical trials. He is industry co-chair for the ASA Biopharmaceutical Section Regulatory-Industry Workshop and has provided statistical training in major conferences including the Joint Statistical Meetings, ASA Biopharmaceutical Section Regulatory-Industry Workshop, and ICSA Applied Statistics Symposium. Soumi Lahiri has 12 years of extensive experience in working different therapeutic areas. She is the former Director of Biostatistics in Clinical Oncology, GlaxoSmithKline. She has also worked in the oncology division of Novartis Pharmaceutical Company for two years. She is an active member of the ASA Biopharmaceutical section and former chair of the membership committee.

Clinical Evaluation of Medical Devices

Karen M. Becker,John J. Whyte
Clinical Evaluation of Medical Devices Book PDF

Author : Karen M. Becker,John J. Whyte
Publisher : Springer Science & Business Media
Page : 360 pages
File Size : 53,8 Mb
Release : 2007-11-05
Category : Technology & Engineering
ISBN : 9781597450041

Get Book

Clinical Evaluation of Medical Devices by Karen M. Becker,John J. Whyte Pdf

The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs.

Statistical Methods and Analyses for Medical Devices

Scott A. Pardo
Statistical Methods and Analyses for Medical Devices Book PDF

Author : Scott A. Pardo
Publisher : Springer Nature
Page : 384 pages
File Size : 46,6 Mb
Release : 2023-04-24
Category : Mathematics
ISBN : 9783031261398

Get Book

Statistical Methods and Analyses for Medical Devices by Scott A. Pardo Pdf

This book provides a reference for people working in the design, development, and manufacturing of medical devices. ​While there are no statistical methods specifically intended for medical devices, there are methods that are commonly applied to various problems in the design, manufacturing, and quality control of medical devices. The aim of this book is not to turn everyone working in the medical device industries into mathematical statisticians; rather, the goal is to provide some help in thinking statistically, and knowing where to go to answer some fundamental questions, such as justifying a method used to qualify/validate equipment, or what information is necessary to support the choice of sample sizes. While, there are no statistical methods specifically designed for analysis of medical device data, there are some methods that seem to appear regularly in relation to medical devices. For example, the assessment of receiver operating characteristic curves is fundamental to development of diagnostic tests, and accelerated life testing is often critical for assessing the shelf life of medical device products. Another example is sensitivity/specificity computations are necessary for in-vitro diagnostics, and Taguchi methods can be very useful for designing devices. Even notions of equivalence and noninferiority have different interpretations in the medical device field compared to pharmacokinetics. It contains topics such as dynamic modeling, machine learning methods, equivalence testing, and experimental design, for example. This book is for those with no statistical experience, as well as those with statistical knowledgeable—with the hope to provide some insight into what methods are likely to help provide rationale for choices relating to data gathering and analysis activities for medical devices.

Statistical Methods in Healthcare

Frederick W. Faltin,Ron S. Kenett,Fabrizio Ruggeri
Statistical Methods in Healthcare Book PDF

Author : Frederick W. Faltin,Ron S. Kenett,Fabrizio Ruggeri
Publisher : John Wiley & Sons
Page : 533 pages
File Size : 46,9 Mb
Release : 2012-07-24
Category : Medical
ISBN : 9781119942047

Get Book

Statistical Methods in Healthcare by Frederick W. Faltin,Ron S. Kenett,Fabrizio Ruggeri Pdf

Statistical Methods in Healthcare In recent years the number of innovative medicinal products and devices submitted and approved by regulatory bodies has declined dramatically. The medical product development process is no longer able to keep pace with increasing technologies, science and innovations and the goal is to develop new scientific and technical tools and to make product development processes more efficient and effective. Statistical Methods in Healthcare focuses on the application of statistical methodologies to evaluate promising alternatives and to optimize the performance and demonstrate the effectiveness of those that warrant pursuit is critical to success. Statistical methods used in planning, delivering and monitoring health care, as well as selected statistical aspects of the development and/or production of pharmaceuticals and medical devices are also addressed. With a focus on finding solutions to these challenges, this book: Provides a comprehensive, in-depth treatment of statistical methods in healthcare, along with a reference source for practitioners and specialists in health care and drug development. Offers a broad coverage of standards and established methods through leading edge techniques. Uses an integrated case study based approach, with focus on applications. Looks at the use of analytical and monitoring schemes to evaluate therapeutic performance. Features the application of modern quality management systems to clinical practice, and to pharmaceutical development and production processes. Addresses the use of modern statistical methods such as Adaptive Design, Seamless Design, Data Mining, Bayesian networks and Bootstrapping that can be applied to support the challenging new vision. Practitioners in healthcare-related professions, ranging from clinical trials to care delivery to medical device design, as well as statistical researchers in the field, will benefit from this book.

Benefit-Risk Assessment Methods in Medical Product Development

Qi Jiang,Weili He
Benefit Risk Assessment Methods in Medical Product Development Book PDF

Author : Qi Jiang,Weili He
Publisher : CRC Press
Page : 255 pages
File Size : 53,5 Mb
Release : 2017-12-19
Category : Mathematics
ISBN : 9781315355016

Get Book

Benefit-Risk Assessment Methods in Medical Product Development by Qi Jiang,Weili He Pdf

Guides You on the Development and Implementation of B–R Evaluations Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B–R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B–R assessments in medicine development and regulation, the need for both a common B–R framework and patient input into B–R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA’s Center for Devices and Radiological Health. The third section examines key elements of B–R evaluations in a product’s life cycle, such as uncertainty evaluation and quantification, quantifying patient B–R trade-off preferences, ways to identify subgroups with the best B–R profiles, and data sources used to assist B–R assessment. The fourth section equips practitioners with tools to conduct B–R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B–R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B–R evaluations.

The Statistical Evaluation of Medical Tests for Classification and Prediction

Margaret Sullivan Pepe
The Statistical Evaluation of Medical Tests for Classification and Prediction Book PDF

Author : Margaret Sullivan Pepe
Publisher : OUP Oxford
Page : 319 pages
File Size : 42,9 Mb
Release : 2003-03-13
Category : Medical
ISBN : 9780191588617

Get Book

The Statistical Evaluation of Medical Tests for Classification and Prediction by Margaret Sullivan Pepe Pdf

This book describes statistical techniques for the design and evaluation of research studies on medical diagnostic tests, screening tests, biomarkers and new technologies for classification and prediction in medicine.

Statistics in Drug Research

Shein-Chung Chow,Jun Shao
Statistics in Drug Research Book PDF

Author : Shein-Chung Chow,Jun Shao
Publisher : CRC Press
Page : 412 pages
File Size : 44,5 Mb
Release : 2002-02-20
Category : Mathematics
ISBN : 0203910141

Get Book

Statistics in Drug Research by Shein-Chung Chow,Jun Shao Pdf

Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation and establish the safety and efficacy of pharmaceutical compounds. Cove

Design and Analysis of Clinical Trials

Shein-Chung Chow,Jen-Pei Liu
Design and Analysis of Clinical Trials Book PDF

Author : Shein-Chung Chow,Jen-Pei Liu
Publisher : Wiley-Interscience
Page : 682 pages
File Size : 43,5 Mb
Release : 1998-06-23
Category : Mathematics
ISBN : UOM:39015053766278

Get Book

Design and Analysis of Clinical Trials by Shein-Chung Chow,Jen-Pei Liu Pdf

A unique, unifying treatment for statistics and science in clinical trials What sets this volume apart from the many books dealing with clinical trials is its integration of statistical and clinical disciplines. Stressing communication between biostatisticians and clinical scientists, this work clearly relates statistical interpretation to clinical issues arising in different stages of pharmaceutical research and development. Plus, the principles presented here are universal enough to be easily adapted in non-biopharmaceutical settings. Design and Analysis of Clinical Trials tackles concepts and methodologies. It not only covers statistical basics such as uncertainty and bias, design considerations such as patient selection, randomization, and the different types of clinical trials but also deals with various methods of data analysis, group sequential procedures for interim analysis, efficacy data evaluation, analysis of safety data, and more. Throughout, the book: * Surveys current and emerging clinical issues and newly developed statistical methods * Presents a critical review of statistical methodologies in various therapeutic areas * Features case studies from actual clinical trials * Minimizes the mathematics involved, making the material widely accessible * Offers each chapter as a self-contained entity * Includes illustrations to highlight the text This monumental reference on all facets of clinical trials is important reading for physicians, clinical and medical researchers, pharmaceutical scientists, clinical programmers, biostatisticians, and anyone involved in this burgeoning area of clinical research. It can also be used as a textbook in graduate-level courses in the field.

Advanced Statistics in Regulatory Critical Clinical Initiatives

Wei Zhang,Fangrong Yan,Feng Chen,Shein-Chung Chow
Advanced Statistics in Regulatory Critical Clinical Initiatives Book PDF

Author : Wei Zhang,Fangrong Yan,Feng Chen,Shein-Chung Chow
Publisher : CRC Press
Page : 501 pages
File Size : 43,6 Mb
Release : 2022-05-25
Category : Mathematics
ISBN : 9781000568028

Get Book

Advanced Statistics in Regulatory Critical Clinical Initiatives by Wei Zhang,Fangrong Yan,Feng Chen,Shein-Chung Chow Pdf

Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields. Key Features: Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development. Makes recommendations to evaluate submissions accurately and reliably. Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development. Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.

Sharing Clinical Trial Data

Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Sharing Clinical Trial Data Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Publisher : National Academies Press
Page : 304 pages
File Size : 49,9 Mb
Release : 2015-04-20
Category : Medical
ISBN : 9780309316323

Get Book

Sharing Clinical Trial Data by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data Pdf

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.