Statistical Thinking For Non Statisticians In Drug Regulation

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Statistical Thinking for Non-Statisticians in Drug Regulation

Richard Kay
Statistical Thinking for Non Statisticians in Drug Regulation Book PDF

Author : Richard Kay
Publisher : John Wiley & Sons
Page : 436 pages
File Size : 47,7 Mb
Release : 2022-11-29
Category : Medical
ISBN : 9781119867401

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Statistical Thinking for Non-Statisticians in Drug Regulation by Richard Kay Pdf

STATISTICAL THINKING FOR NON-STATISTICIANS IN DRUG REGULATION Statistical methods in the pharmaceutical industry are accepted as a key element in the design and analysis of clinical studies. Increasingly, the medical and scientific community are aligning with the regulatory authorities and recognizing that correct statistical methodology is essential as the basis for valid conclusions. In order for those correct and robust methods to be successfully employed there needs to be effective communication across disciplines at all stages of the planning, conducting, analyzing and reporting of clinical studies associated with the development and evaluation of new drugs and devices. Statistical Thinking for Non-Statisticians in Drug Regulation provides a comprehensive in-depth guide to statistical methodology for pharmaceutical industry professionals, including physicians, investigators, medical science liaisons, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in pharmacovigilance. The author’s years of experience and up-to-date familiarity with pharmaceutical regulations and statistical practice within the wider clinical community make this an essential guide for the those working in and with the industry. The third edition of Statistical Thinking for Non-Statisticians in Drug Regulation includes: A detailed new chapter on Estimands in line with the 2019 Addendum to ICH E9 Major new sections on topics including Combining Hierarchical Testing and Alpha Adjustment, Biosimilars, Restricted Mean Survival Time, Composite Endpoints and Cumulative Incidence Functions, Adjusting for Cross-Over in Oncology, Inverse Propensity Score Weighting, and Network Meta-Analysis Updated coverage of many existing topics to reflect new and revised guidance from regulatory authorities and author experience Statistical Thinking for Non-Statisticians in Drug Regulation is a valuable guide for pharmaceutical and medical device industry professionals, as well as statisticians joining the pharmaceutical industry and students and teachers of drug development.

Innovative Statistics in Regulatory Science

Shein-Chung Chow
Innovative Statistics in Regulatory Science Book PDF

Author : Shein-Chung Chow
Publisher : CRC Press
Page : 298 pages
File Size : 43,7 Mb
Release : 2019-11-14
Category : Mathematics
ISBN : 9781000710816

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Innovative Statistics in Regulatory Science by Shein-Chung Chow Pdf

Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in the review and approval process of regulatory submissions of pharmaceutical products. In addition, statistics in regulatory science are involved with the development of regulatory policy, guidance, and regulatory critical clinical initiatives related research. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are commonly encountered in regulatory science of pharmaceutical research and development including topics related to research activities, review of regulatory submissions, recent critical clinical initiatives, and policy/guidance development in regulatory science. Devoted entirely to discussing statistics in regulatory science for pharmaceutical development. Reviews critical issues (e.g., endpoint/margin selection and complex innovative design such as adaptive trial design) in the pharmaceutical development and regulatory approval process. Clarifies controversial statistical issues (e.g., hypothesis testing versus confidence interval approach, missing data/estimands, multiplicity, and Bayesian design and approach) in review/approval of regulatory submissions. Proposes innovative thinking regarding study designs and statistical methods (e.g., n-of-1 trial design, adaptive trial design, and probability monitoring procedure for sample size) for rare disease drug development. Provides insight regarding current regulatory clinical initiatives (e.g., precision/personalized medicine, biomarker-driven target clinical trials, model informed drug development, big data analytics, and real world data/evidence). This book provides key statistical concepts, innovative designs, and analysis methods that are useful in regulatory science. Also included are some practical, challenging, and controversial issues that are commonly seen in the review and approval process of regulatory submissions. About the author Shein-Chung Chow, Ph.D. is currently a Professor at Duke University School of Medicine, Durham, NC. He was previously the Associate Director at the Office of Biostatistics, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA). Dr. Chow has also held various positions in the pharmaceutical industry such as Vice President at Millennium, Cambridge, MA, Executive Director at Covance, Princeton, NJ, and Director and Department Head at Bristol-Myers Squibb, Plainsboro, NJ. He was elected Fellow of the American Statistical Association and an elected member of the ISI (International Statistical Institute). Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Biostatistics Book Series, Chapman and Hall/CRC Press, Taylor & Francis, New York. Dr. Chow is the author or co-author of over 300 methodology papers and 30 books.

Statistics for Non-Statisticians

Birger Madsen
Statistics for Non Statisticians Book PDF

Author : Birger Madsen
Publisher : Springer Science & Business Media
Page : 172 pages
File Size : 48,5 Mb
Release : 2011-04-13
Category : Mathematics
ISBN : 9783642176562

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Statistics for Non-Statisticians by Birger Madsen Pdf

This book was written for those who need to know how to collect, analyze and present data. It is meant to be a first course for practitioners, a book for private study or brush-up on statistics, and supplementary reading for general statistics classes. The book is untraditional, both with respect to the choice of topics and the presentation. The topics were determined by what is most useful for practical statistical work: even experienced statisticians will find new topics or new approaches to traditional topics. The presentation is as non-mathematical as possible. Mathematical formulae are presented only if they are necessary for calculations and/or add to readers’ understanding. A sample survey is developed as a realistic example throughout the book, and many further examples are presented, which also use data spreadsheets from a supplementary website.

Statistical Issues in Drug Development

Stephen S. Senn
Statistical Issues in Drug Development Book PDF

Author : Stephen S. Senn
Publisher : John Wiley & Sons
Page : 523 pages
File Size : 46,9 Mb
Release : 2008-02-28
Category : Medical
ISBN : 0470723572

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Statistical Issues in Drug Development by Stephen S. Senn Pdf

Drug development is the process of finding and producingtherapeutically useful pharmaceuticals, turning them into safe andeffective medicine, and producing reliable information regardingthe appropriate dosage and dosing intervals. With regulatoryauthorities demanding increasingly higher standards in suchdevelopments, statistics has become an intrinsic and criticalelement in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents anessential and thought provoking guide to the statistical issues andcontroversies involved in drug development. This highly readable second edition has been updated toinclude: Comprehensive coverage of the design and interpretation ofclinical trials. Expanded sections on missing data, equivalence, meta-analysisand dose finding. An examination of both Bayesian and frequentist methods. A new chapter on pharmacogenomics and expanded coverage ofpharmaco-epidemiology and pharmaco-economics. Coverage of the ICH guidelines, in particular ICH E9,Statistical Principles for Clinical Trials. It is hoped that the book will stimulate dialogue betweenstatisticians and life scientists working within the pharmaceuticalindustry. The accessible and wide-ranging coverage make itessential reading for both statisticians and non-statisticiansworking in the pharmaceutical industry, regulatory bodies andmedical research institutes. There is also much to benefitundergraduate and postgraduate students whose courses include amedical statistics component.

FDA Regulatory Affairs

David Mantus,Douglas J. Pisano
FDA Regulatory Affairs Book PDF

Author : David Mantus,Douglas J. Pisano
Publisher : CRC Press
Page : 401 pages
File Size : 48,7 Mb
Release : 2014-02-28
Category : Medical
ISBN : 9781841849201

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FDA Regulatory Affairs by David Mantus,Douglas J. Pisano Pdf

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.

Essential Statistics for the Pharmaceutical Sciences

Philip Rowe
Essential Statistics for the Pharmaceutical Sciences Book PDF

Author : Philip Rowe
Publisher : John Wiley & Sons
Page : 432 pages
File Size : 47,9 Mb
Release : 2015-07-20
Category : Medical
ISBN : 9781118913413

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Essential Statistics for the Pharmaceutical Sciences by Philip Rowe Pdf

Essential Statistics for the Pharmaceutical Sciences is targeted at all those involved in research in pharmacology, pharmacy or other areas of pharmaceutical science; everybody from undergraduate project students to experienced researchers should find the material they need. This book will guide all those who are not specialist statisticians in using sound statistical principles throughout the whole journey of a research project - designing the work, selecting appropriate statistical methodology and correctly interpreting the results. It deliberately avoids detailed calculation methodology. Its key features are friendliness and clarity. All methods are illustrated with realistic examples from within pharmaceutical science. This edition now includes expanded coverage of some of the topics included in the first edition and adds some new topics relevant to pharmaceutical research. a clear, accessible introduction to the key statistical techniques used within the pharmaceutical sciences all examples set in relevant pharmaceutical contexts. key points emphasised in summary boxes and warnings of potential abuses in ‘pirate boxes’. supplementary material - full data sets and detailed instructions for carrying out analyses using packages such as SPSS or Minitab – provided at: https://www.wiley.com/go/rowe/statspharmascience2e An invaluable introduction to statistics for any science student and an essential text for all those involved in pharmaceutical research at whatever level.

Small Clinical Trials

Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
Small Clinical Trials Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
Publisher : National Academies Press
Page : 222 pages
File Size : 45,9 Mb
Release : 2001-01-01
Category : Medical
ISBN : 0309171148

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Small Clinical Trials by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials Pdf

Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

Understanding Statistics and Experimental Design

Michael H. Herzog,Gregory Francis,Aaron Clarke
Understanding Statistics and Experimental Design Book PDF

Author : Michael H. Herzog,Gregory Francis,Aaron Clarke
Publisher : Springer
Page : 146 pages
File Size : 45,8 Mb
Release : 2019-08-13
Category : Science
ISBN : 9783030034993

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Understanding Statistics and Experimental Design by Michael H. Herzog,Gregory Francis,Aaron Clarke Pdf

This open access textbook provides the background needed to correctly use, interpret and understand statistics and statistical data in diverse settings. Part I makes key concepts in statistics readily clear. Parts I and II give an overview of the most common tests (t-test, ANOVA, correlations) and work out their statistical principles. Part III provides insight into meta-statistics (statistics of statistics) and demonstrates why experiments often do not replicate. Finally, the textbook shows how complex statistics can be avoided by using clever experimental design. Both non-scientists and students in Biology, Biomedicine and Engineering will benefit from the book by learning the statistical basis of scientific claims and by discovering ways to evaluate the quality of scientific reports in academic journals and news outlets.

The Drug Development Paradigm in Oncology

National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,National Cancer Policy Forum
The Drug Development Paradigm in Oncology Book PDF

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,National Cancer Policy Forum
Publisher : National Academies Press
Page : 145 pages
File Size : 52,7 Mb
Release : 2018-02-12
Category : Medical
ISBN : 9780309457972

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The Drug Development Paradigm in Oncology by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,National Cancer Policy Forum Pdf

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.

Nonclinical Statistics for Pharmaceutical and Biotechnology Industries

Lanju Zhang
Nonclinical Statistics for Pharmaceutical and Biotechnology Industries Book PDF

Author : Lanju Zhang
Publisher : Springer
Page : 698 pages
File Size : 50,5 Mb
Release : 2016-01-13
Category : Medical
ISBN : 9783319235585

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Nonclinical Statistics for Pharmaceutical and Biotechnology Industries by Lanju Zhang Pdf

This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions.

Critical Thinking in Clinical Research

Felipe Fregni,Ben M. W. Illigens
Critical Thinking in Clinical Research Book PDF

Author : Felipe Fregni,Ben M. W. Illigens
Publisher : Oxford University Press
Page : 537 pages
File Size : 51,7 Mb
Release : 2018
Category : Medical
ISBN : 9780199324491

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Critical Thinking in Clinical Research by Felipe Fregni,Ben M. W. Illigens Pdf

Critical Thinking in Clinical Research explains the fundamentals of clinical research in a case-based approach. The core concept is to combine a clear and concise transfer of information and knowledge with an engagement of the reader to develop a mastery of learning and critical thinking skills. The book addresses the main concepts of clinical research, basics of biostatistics, advanced topics in applied biostatistics, and practical aspects of clinical research, with emphasis on clinical relevance across all medical specialties.

Statistics for Nursing

Elizabeth Heavey
Statistics for Nursing Book PDF

Author : Elizabeth Heavey
Publisher : Jones & Bartlett Publishers
Page : 273 pages
File Size : 50,6 Mb
Release : 2015
Category : Nursing
ISBN : 9781284042207

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Statistics for Nursing by Elizabeth Heavey Pdf

Statistics for Nursing: A Practical Approach, Second Edition is designed in accordance with the Conversation Theory of Gordon Pask and presents the complicated topic of statistics in an understandable manner for entry level nurses. The underlying principle of this design is to give students the opportunity to practice statistics while they learn statistics. The text accomplishes this through the inclusion of relevant clinical examples followed by end of chapter application exercises. The Second Edition focuses on topics around Nursing Practice and was selected based on a review of the current statistical techniques used most frequently in nursing literature. The top ten statistical techniques used throughout nursing are covered very clearly in the text and without any irrelevant complicating concepts. This text meets the needs of both undergraduate nursing research students who need to learn how to critically analyze literature as well as graduate DNP students who must also be familiar with statistics for nursing in accordance with the rigor of the DNP program. Key Features:Designed in accordance with the Conversation Theory of Gordon PaskClinically Relevant examples found in each chapterReview questions at the end of each chapterThree comprehensive appendices featuring nursing research articles Opportunity for review and application of statistics via an online resourceInstructor Resources include: Recorded LecturesSPSS Video Written TutorialsHomework Review VideosTest Bank

Interface between Regulation and Statistics in Drug Development

Demissie Alemayehu,Birol Emir,Michael Gaffney
Interface between Regulation and Statistics in Drug Development Book PDF

Author : Demissie Alemayehu,Birol Emir,Michael Gaffney
Publisher : CRC Press
Page : 122 pages
File Size : 52,8 Mb
Release : 2020-11-11
Category : Medical
ISBN : 9781000215908

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Interface between Regulation and Statistics in Drug Development by Demissie Alemayehu,Birol Emir,Michael Gaffney Pdf

With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the interplay between the two disciplines, including emerging themes pertaining to the acceleration of the development of pharmaceutical medicines to serve patients with unmet needs. Features: Regulatory and statistical interactions throughout the drug development continuum The critical role of the statistician in relation to the changing regulatory and healthcare landscapes Statistical issues that commonly arise in the course of drug development and regulatory interactions Trending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunities The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors’ decades of experience in the pharmaceutical industry and academia, and extensive regulatory experience, comes through in the many examples throughout the book.

OpenIntro Statistics

David Diez,Christopher Barr,Mine Çetinkaya-Rundel
OpenIntro Statistics Book PDF

Author : David Diez,Christopher Barr,Mine Çetinkaya-Rundel
Publisher : Unknown
Page : 128 pages
File Size : 55,5 Mb
Release : 2015-07-02
Category : Electronic
ISBN : 1943450048

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OpenIntro Statistics by David Diez,Christopher Barr,Mine Çetinkaya-Rundel Pdf

The OpenIntro project was founded in 2009 to improve the quality and availability of education by producing exceptional books and teaching tools that are free to use and easy to modify. We feature real data whenever possible, and files for the entire textbook are freely available at openintro.org. Visit our website, openintro.org. We provide free videos, statistical software labs, lecture slides, course management tools, and many other helpful resources.

Common Errors in Statistics (and How to Avoid Them)

Phillip I. Good,James W. Hardin
Common Errors in Statistics and How to Avoid Them Book PDF

Author : Phillip I. Good,James W. Hardin
Publisher : John Wiley & Sons
Page : 231 pages
File Size : 44,5 Mb
Release : 2011-09-20
Category : Mathematics
ISBN : 9781118211274

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Common Errors in Statistics (and How to Avoid Them) by Phillip I. Good,James W. Hardin Pdf

Praise for the Second Edition "All statistics students and teachers will find in this book a friendly and intelligentguide to . . . applied statistics in practice." —Journal of Applied Statistics ". . . a very engaging and valuable book for all who use statistics in any setting." —CHOICE ". . . a concise guide to the basics of statistics, replete with examples . . . a valuablereference for more advanced statisticians as well." —MAA Reviews Now in its Third Edition, the highly readable Common Errors in Statistics (and How to Avoid Them) continues to serve as a thorough and straightforward discussion of basic statistical methods, presentations, approaches, and modeling techniques. Further enriched with new examples and counterexamples from the latest research as well as added coverage of relevant topics, this new edition of the benchmark book addresses popular mistakes often made in data collection and provides an indispensable guide to accurate statistical analysis and reporting. The authors' emphasis on careful practice, combined with a focus on the development of solutions, reveals the true value of statistics when applied correctly in any area of research. The Third Edition has been considerably expanded and revised to include: A new chapter on data quality assessment A new chapter on correlated data An expanded chapter on data analysis covering categorical and ordinal data, continuous measurements, and time-to-event data, including sections on factorial and crossover designs Revamped exercises with a stronger emphasis on solutions An extended chapter on report preparation New sections on factor analysis as well as Poisson and negative binomial regression Providing valuable, up-to-date information in the same user-friendly format as its predecessor, Common Errors in Statistics (and How to Avoid Them), Third Edition is an excellent book for students and professionals in industry, government, medicine, and the social sciences.