Encyclopedia Of Biopharmaceutical Statistics Four Volume Set

Author : Shein-Chung Chow
Publisher : CRC Press
Page : 2434 pages
File Size : 52,7 Mb
Release : 2018-09-03
Category : Medical
ISBN : 9781351110266

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Encyclopedia of Biopharmaceutical Statistics - Four Volume Set by Shein-Chung Chow Pdf

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.

Author : Shein-Chung Chow
Publisher : Unknown
Page : 0 pages
File Size : 52,7 Mb
Release : 2018
Category : Drug development
ISBN : 0815363184

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Biopharmaceutical Statistics by Shein-Chung Chow Pdf

Author : Shein-Chung Chow
Publisher : CRC Press
Page : 4057 pages
File Size : 42,7 Mb
Release : 2018-09-03
Category : Medical
ISBN : 9781351110259

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Encyclopedia of Biopharmaceutical Statistics - Four Volume Set by Shein-Chung Chow Pdf

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.

Author : Shein-Chung Chow
Publisher : Unknown
Page : 128 pages
File Size : 43,9 Mb
Release : 2010
Category : MATHEMATICS
ISBN : 1351237128

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Encyclopedia of Biopharmaceutical Statistics by Shein-Chung Chow Pdf

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]

Author : Shein-Chung Chow
Publisher : Unknown
Page : 0 pages
File Size : 46,6 Mb
Release : 2010
Category : Electronic
ISBN : OCLC:837808317

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Encyclopedia of Biopharmaceutical Statistics by Shein-Chung Chow Pdf

Author : Shein-Chung Chow
Publisher : CRC Press
Page : 0 pages
File Size : 46,5 Mb
Release : 2010-05-20
Category : Mathematics
ISBN : 143982245X

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Encyclopedia of Biopharmaceutical Statistics, Third Edition by Shein-Chung Chow Pdf

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

Author : Sven Erik Jorgensen
Publisher : CRC Press
Page : 3513 pages
File Size : 46,7 Mb
Release : 2012-12-13
Category : Technology & Engineering
ISBN : 9781000031720

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Encyclopedia of Environmental Management, Four Volume Set by Sven Erik Jorgensen Pdf

Winner of an Outstanding Academic Title Award from CHOICE Magazine Encyclopedia of Environmental Management gives a comprehensive overview of environmental problems, their sources, their assessment, and their solutions. Through in-depth entries and a topical table of contents, readers will quickly find answers to questions about specific pollution and management issues. Edited by the esteemed Sven Erik Jørgensen and an advisory board of renowned specialists, this four-volume set shares insights from more than 500 contributors—all experts in their fields. The encyclopedia provides basic knowledge for an integrated and ecologically sound management system. Nearly 400 alphabetical entries cover everything from air, soil, and water pollution to agriculture, energy, global pollution, toxic substances, and general pollution problems. Using a topical table of contents, readers can also search for entries according to the type of problem and the methodology. This allows readers to see the overall picture at a glance and find answers to the core questions: What is the pollution problem, and what are its sources? What is the "big picture," or what background knowledge do we need? How can we diagnose the problem, both qualitatively and quantitatively, using monitoring and ecological models, indicators, and services? How can we solve the problem with environmental technology, ecotechnology, cleaner technology, and environmental legislation? How do we address the problem as part of an integrated management strategy? This accessible encyclopedia examines the entire spectrum of tools available for environmental management. An indispensable resource, it guides environmental managers to find the best possible solutions to the myriad pollution problems they face. Also Available Online This 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 us to inquire about subscription options and print/online combination packages. US: (Tel) 1.888.318.2367 / (email) [email protected] International: (Tel) +44 (0) 20 7017 6062 / (email) [email protected]

Author : Shein-Chung Chow
Publisher : CRC Press
Page : 1000 pages
File Size : 44,5 Mb
Release : 2003-06-04
Category : Mathematics
ISBN : 0824742613

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Encyclopedia of Biopharmaceutical Statistics, Second Edition by Shein-Chung Chow Pdf

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.

Author : Shein-Chung Chow
Publisher : Unknown
Page : 739 pages
File Size : 54,7 Mb
Release : 2010
Category : Electronic
ISBN : OCLC:837808482

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Encyclopedia of Biopharmaceutical Statistics by Shein-Chung Chow Pdf

Author : Shein-Chung Chow
Publisher : CRC Press
Page : 562 pages
File Size : 43,5 Mb
Release : 2000
Category : Medical
ISBN : UOM:39015050146177

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Encyclopedia Of Biopharma- Ceutical Statistics by Shein-Chung Chow Pdf

"This reference covers all key topics for evaluation of data at critical stages in the pharmaceutical research and development process - highlighting the vital areas of statistical design and regulatory requirements." "Each entry of the Encyclopedia includes: self-contained, self-explanatory, and accessible data to nonbiostatisticians; "real-world" examples of statistical design and practice in the pharmaceutical industry; thoroughly up-to-date standards on good laboratory practice (GLP), good clinical practice (GCP), current good manufacturing practice (cGMP), and good statistics practice (GSP)." "Written by over 75 acclaimed international experts, the Encyclopedia of Biopharmaceutical Statistics explores interrelations among physiochemical properties of drugs in dosage form and their pharmacological, toxicological, and clinical effects; elucidates new applications of computer telephony technology; surveys the crucial relationship of the Food and Drug Administration (FDA) to pharmaceutical development, clinical trials and testing, and marketing; showcases monoclonal antibodies, cytokines, hematopoietic growth factors, tumor vaccines, xenotherapies, and cell-selection devices; describes one-sided equivalence and noninferiority trials; investigates genetic toxicology tests and other animal studies; illustrates assay technologies measuring gravimetric mass, potency, and physical or biological properties of analytes; discusses proposals for internationally standardized systems of data collection and analysis; and supplies vital economic data on factors such as reference-based pricing, burden-of-illness studies, cost-utility analysis, and cost-benefit analysis." "Containing over 2200 references, equations, tables, and drawings, the Encyclopedia of Biopharmaceutical Statistics serves as a reference for biostatisticians, chemists, pharmaceutical scientists, clinical researchers, and development pharmacists in the pharmaceutical industry and regulatory agencies, as well as upper-level undergraduate and graduate students in these disciplines."--BOOK JACKET.Title Summary field provided by Blackwell North America, Inc. All Rights Reserved

Author : Alex Dmitrienko,Christy Chuang-Stein,Ralph B. D'Agostino
Publisher : SAS Institute
Page : 464 pages
File Size : 42,5 Mb
Release : 2007
Category : Computers
ISBN : 9781599943572

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Pharmaceutical Statistics Using SAS by Alex Dmitrienko,Christy Chuang-Stein,Ralph B. D'Agostino Pdf

Introduces a range of data analysis problems encountered in drug development and illustrates them using case studies from actual pre-clinical experiments and clinical studies. Includes a discussion of methodological issues, practical advice from subject matter experts, and review of relevant regulatory guidelines.

Author : Karl E. Peace,Ding-Geng Chen,Sandeep Menon
Publisher : Springer
Page : 245 pages
File Size : 48,8 Mb
Release : 2018-08-21
Category : Medical
ISBN : 9789811078262

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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.

Author : Sanford Bolton
Publisher : Unknown
Page : 552 pages
File Size : 49,9 Mb
Release : 1984
Category : Pharmacy
ISBN : UOM:39015026044431

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Pharmaceutical Statistics by Sanford Bolton Pdf

For pharmacists and health science-related scientists who want to learn statistics. Requires no previous statistical education or math beyond basic arithmetic. Annotation copyrighted by Book News, Inc., Portland, OR

Author : Scott D. Patterson,Byron Jones
Publisher : CRC Press
Page : 434 pages
File Size : 48,8 Mb
Release : 2017-03-27
Category : Mathematics
ISBN : 9781466585218

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Bioequivalence and Statistics in Clinical Pharmacology by Scott D. Patterson,Byron Jones Pdf

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.

Author : Karl E. Peace,Ding-Geng Chen,Sandeep Menon
Publisher : Springer
Page : 426 pages
File Size : 52,5 Mb
Release : 2018-09-03
Category : Medical
ISBN : 9789811078200

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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 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.