Download or read book Encyclopedia of Biopharmaceutical Statistics Four Volume Set written by Shein-Chung Chow and published by CRC Press. This book was released on 2018-09-03 with total page 2434 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.

Download or read book Biopharmaceutical Statistics written by Shein-Chung Chow and published by . This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Biopharmaceutical Applied Statistics Symposium written by Karl E. Peace and published by Springer. This book was released on 2018-08-20 with total page 414 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 first of the 3-volume book series. The topics covered include: A Statistical Approach to Clinical Trial Simulations, Comparison of Statistical Analysis Methods Using Modeling and Simulation for Optimal Protocol Design, Adaptive Trial Design in Clinical Research, Best Practices and Recommendations for Trial Simulations in the Context of Designing Adaptive Clinical Trials, Designing and Analyzing Recurrent Event Data Trials, Bayesian Methodologies for Response-Adaptive Allocation, Addressing High Placebo Response in Neuroscience Clinical Trials, Phase I Cancer Clinical Trial Design: Single and Combination Agents, Sample Size and Power for the Mixed Linear Model, Crossover Designs in Clinical Trials, Data Monitoring: Structure for Clinical Trials and Sequential Monitoring Procedures, Design and Data Analysis for Multiregional Clinical Trials – Theory and Practice, Adaptive Group-Sequential Multi-regional Outcome Studies in Vaccines, Development and Validation of Patient-reported Outcomes, Interim Analysis of Survival Trials: Group Sequential Analyses, and Conditional Power – A Non-proportional Hazards Perspective.

Download or read book Pharmaceutical Statistics written by Ray Liu and published by Springer. This book was released on 2019-06-12 with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents the proceedings of the 39th annual Midwest Biopharmaceutical Statistics Workshop (MBSW), held in Muncie, Indiana on May 16–18, 2016. It consists of selected peer- reviewed and revised papers on topics ranging from statistical applications in drug discovery and CMC to biomarkers, clinical trials, and statistical programming. All contributions feature original research, and together they cover the full spectrum of pharmaceutical R&D – with a special focus on emergent topics such as biosimilarity, bioequivalence, clinical trial design, and subgroup identification. Founded in 1978, the MBSW has provided a forum for statisticians to share knowledge, research, and applications on key statistical topics in pharmaceutical R&D for almost forty years, with the 2016 conference theme being “The Power and 3 I’s of Statistics: Innovation, Impact and Integrity.” The papers gathered here will be of interest to all researchers whose work involves the quantitative aspects of pharmaceutical research and development, including pharmaceutical statisticians who want to keep up-to-date with the latest trends, as well as academic statistics researchers looking for areas of application.

Download or read book Biopharmaceutical Applied Statistics Symposium written by Karl E. Peace and published by Springer. This book was released on 2018-09-03 with total page 431 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 third of the 3-volume book series. The topics covered include: Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints, Uses of Mixture Normal Distribution in Genomics and Otherwise, Personalized Medicine – Design Considerations, Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials, High Dimensional Data in Genomics; Synergy or Additivity - The Importance of Defining the Primary Endpoint, Full Bayesian Adaptive Dose Finding Using Toxicity Probability Interval (TPI), Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials, Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals, Randomized Clinical Trials for Orphan Drug Development, Mediation Modeling in Randomized Trials with Non-normal Outcome Variables, Statistical Considerations in Using Images in Clinical Trials, Interesting Applications over 30 Years of Consulting, Uncovering Fraud, Misconduct and Other Data Quality Issues in Clinical Trials, Development and Evaluation of High Dimensional Prognostic Models, and Design and Analysis of Biosimilar Studies.

Download or read book Biopharmaceutical Applied Statistics Symposium written by Karl E. Peace and published by Springer. This book was released on 2018-08-21 with total page 251 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Encyclopedia of Biopharmaceutical Statistics written by Shein-Chung Chow and published by . This book was released on 2010 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, there has been an explosive growth of biopharmaceutical and clinical research, including the development of new medicines for treating severe or life-threatening diseases. Biopharmaceutical statistics plays an extremely important role in ensuring not only the efficacy and safety of the medicine under investigation, but also that the pharmaceutical product possesses good drug characteristics, such as identity, strength, purity, quality, stability, and reproducibility. Widely used by pharmaceutical scientists, clinical researchers, and biostatistics, the Encyclopedia of Biopharmaceutical Statistics, Third Edition is an essential resource on the evolving state of this important field. New to the Third Edition 89 new chapters, bringing the total number of chapters to 230 Updated information on changes in regulatory requirements for drug review/approval processes Recent developments in statistical design and methodology Important topics, including adaptive design in clinical research, translational medicine, statistical genetics, biomarker development, target clinical trials, follow-on biologics, and traditional Chinese medicine Also Available OnlineThis Taylor & Francis encyclopedia is also available through online subscription, offering a variety of extra benefits for researchers, students, and librarians, including: Citation tracking and alerts Active reference linking Saved searches and marked lists HTML and PDF format options Contact Taylor and Francis for more information or to inquire about subscription options and print/online combination packages.US: (Tel) 1.888.318.2367; (E-mail) [email protected]: (Tel) +44 (0) 20 7017 6062; (E-mail) [email protected]

Download or read book Bioequivalence and Statistics in Clinical Pharmacology written by Scott D. Patterson and published by CRC Press. This book was released on 2017-03-27 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established, including recent regulatory changes in design and analysis and in particular sample-size adaptation, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, proof-of-concept trials, dose-proportionality trials, and vaccines trials. This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials. Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS.

Download or read book Encyclopedia of Biopharmaceutical Statistics Third Edition written by Shein-Chung Chow and published by CRC Press. This book was released on 2010-05-20 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, there has been an explosive growth of biopharmaceutical and clinical research, including the development of new medicines for treating severe or life-threatening diseases. Biopharmaceutical statistics plays an extremely important role in ensuring not only the efficacy and safety of the medicine under investigation, but also that the pharmaceutical product possesses good drug characteristics, such as identity, strength, purity, quality, stability, and reproducibility. Widely used by pharmaceutical scientists, clinical researchers, and biostatistics, the Encyclopedia of Biopharmaceutical Statistics, Third Edition is an essential resource on the evolving state of this important field. New to the Third Edition 89 new chapters, bringing the total number of chapters to 230 Updated information on changes in regulatory requirements for drug review/approval processes Recent developments in statistical design and methodology Important topics, including adaptive design in clinical research, translational medicine, statistical genetics, biomarker development, target clinical trials, follow-on biologics, and traditional Chinese medicine

Download or read book Encyclopedia of Biopharmaceutical Statistics Second Edition written by Shein-Chung Chow and published by CRC Press. This book was released on 2003-06-04 with total page 1000 pages. Available in PDF, EPUB and Kindle. Book excerpt: The only encyclopedia that specifically focuses on biopharmaceutical statistics, the 3rd Edition provides a well-balanced summary of current regulatory requirements, along with a comprehensive and unified presentation of designs and analyses used at different stages of biopharmaceutical and clinical research and development. This is the definitive statistical guide for the entire pipeline of drug/pharmaceutical product development: from non-clinical and pre-clinical assessments and manufacturing processes through to clinical trials, regulatory processes and postmarketing surveillence. Thoroughly exploring emerging technologies, concepts, and trends, this edition incorporates 89 brand new chapters on subjects such as biomarker development, target clinical trials and follow-on biologics. Previous contents of this title have been revised and updated, and cover topics ranging from in vitro bioequivalence testing and dissolution profile comparison to bridging studies, MedDRA, vaccine clinical trials and medical devices. The encyclopedia also includes popular topics that are currently under discussion within regulatory agencies and the pharmaceutical/biotech industry, such as pharmacoeconomics, reproducibility and probability in clinical research. Available in hard copy and online formats, this highly specialised book is a must-have resource for pharmaceutical R&D departments as well as for statisticians and researchers who work on clinical trials regulated by the FDA.

Download or read book Biopharmaceutical Applied Statistics Symposium written by Karl E. Peace and published by . This book was released on 2018 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 third of the 3-volume book series. The topics covered include: Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints, Uses of Mixture Normal Distribution in Genomics and Otherwise, Personalized Medicine - Design Considerations, Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials, High Dimensional Data in Genomics; Synergy or Additivity - The Importance of Defining the Primary Endpoint, Full Bayesian Adaptive Dose Finding Using Toxicity Probability Interval (TPI), Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials, Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals, Randomized Clinical Trials for Orphan Drug Development, Mediation Modeling in Randomized Trials with Non-normal Outcome Variables, Statistical Considerations in Using Images in Clinical Trials, Interesting Applications over 30 Years of Consulting, Uncovering Fraud, Misconduct and Other Data Quality Issues in Clinical Trials, Development and Evaluation of High Dimensional Prognostic Models, and Design and Analysis of Biosimilar Studies.

Download or read book Biopharmaceutical Sequential Statistical Applications written by Karl E. Peace and published by CRC Press. This book was released on 1992-03-25 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focusing on group sequential procedures, summarizes the sequential statistical methods used in anticancer, antiviral, cardiovascular, and gastrointestinal drug research and screening. The clinical and preclinical applications are mainly presented as case studies, many of which form part of New Drug

Download or read book Essential Statistics for the Pharmaceutical Sciences written by Philip Rowe and published by John Wiley & Sons. This book was released on 2007-05-04 with total page 309 pages. Available in PDF, EPUB and Kindle. Book excerpt: "... this text takes a novel approach... The style... is not as dry as other statistics texts, and so should not be intimidating even to a relative newcomer to the subject... The layout is easy to navigate, there are chapter aims, summaries and “key point boxes” throughout." -The Pharmaceutical Journal, 2008 This text is a clear, accessible introduction to the key statistical techniques employed for the analysis of data within this subject area. Written in a concise and logical manner, the book explains why statistics are necessary and discusses the issues that experimentalists need to consider. The reader is carefully taken through the whole process, from planning an experiment to interpreting the results, avoiding unnecessary calculation methodology. The most commonly used statistical methods are described in terms of their purpose, when they should be used and what they mean once they have been performed. Numerous examples are provided throughout the text, all within a pharmaceutical context, with key points highlighted in summary boxes to aid student understanding. Essential Statistics for the Pharmaceutical Sciences takes a new and innovative approach to statistics with an informal style that will appeal to the reader who finds statistics a challenge! This book is an invaluable introduction to statistics for any science student. It is an essential text for students taking biomedical or pharmaceutical-based science degrees and also a useful guide for researchers.

Download or read book Statistical Issues in Drug Research and Development written by Karl E. Peace and published by CRC Press. This book was released on 2017-09-19 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a compilation of topics addressed by the ASA Biopharmaceutical Section work groups, including the etiology and evolution of the work groups, the work group guidelines and structure, and the statistical issues associated with clinical trials in clinical drug development programs.

Download or read book Causal Inference in Pharmaceutical Statistics written by Yixin Fang and published by CRC Press. This book was released on 2024-06-24 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: Causal Inference in Pharmaceutical Statistics introduces the basic concepts and fundamental methods of causal inference relevant to pharmaceutical statistics. This book covers causal thinking for different types of commonly used study designs in the pharmaceutical industry, including but not limited to randomized controlled clinical trials, longitudinal studies, singlearm clinical trials with external controls, and real-world evidence studies. The book starts with the central questions in drug development and licensing, takes the reader through the basic concepts and methods via different study types and through different stages, and concludes with a roadmap to conduct causal inference in clinical studies. The book is intended for clinical statisticians and epidemiologists working in the pharmaceutical industry. It will also be useful to graduate students in statistics, biostatistics, and data science looking to pursue a career in the pharmaceutical industry. Key Features: Causal inference book for clinical statisticians in the pharmaceutical industry Introductory level on the most important concepts and methods Align with FDA and ICH guidance documents Across different stages of clinical studies: plan, design, conduct, analysis, and interpretation Cover a variety of commonly used study designs

Download or read book Multiple Testing Problems in Pharmaceutical Statistics written by Alex Dmitrienko and published by CRC Press. This book was released on 2009-12-08 with total page 323 pages. Available in PDF, EPUB and Kindle. Book excerpt: Useful Statistical Approaches for Addressing Multiplicity IssuesIncludes practical examples from recent trials Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical industry, academia, and regulatory agencies, Multiple Testing Problems in Pharmaceutical Statistics explores the rapidly growing area of multiple c

Download or read book Mathematical and Statistical Skills in the Biopharmaceutical Industry written by Arkadiy Pitman and published by CRC Press. This book was released on 2019-07-15 with total page 247 pages. Available in PDF, EPUB and Kindle. Book excerpt: Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development. It was written to share a quintessence of the authors’ experiences acquired during many years of relevant work in the biopharmaceutical industry. The book will be useful will be useful for biopharmaceutical industry statisticians at different seniority levels and for graduate students who consider a biostatistics-related career in this industry. Features: Describes a system of principles for pragmatic problem solving in clinical drug development. Discusses differences in the work of a biostatistician in small pharma and big pharma. Explains the importance/relevance of statistical programming and data management for biostatistics and necessity for integration on various levels. Describes some useful statistical background that can be capitalized upon in the drug development enterprise. Explains some hot topics and current trends in biostatistics in simple, non-technical terms. Discusses incompleteness of any system of standard operating procedures, rules and regulations. Provides a classification of scoring systems and proposes a novel approach for evaluation of the safety outcome for a completed randomized clinical trial. Presents applications of the problem solving philosophy in a highly problematic transfusion field where many investigational compounds have failed. Discusses realistic planning of open-ended projects.