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Author: Shein-Chung Chow
Publisher: CRC Press
ISBN: 1351110268
Category : Medical
Languages : en
Pages : 2434
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Book Description
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: CRC Press
ISBN: 1351110268
Category : Medical
Languages : en
Pages : 2434
Get Book Here
Book Description
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: Sven Erik Jorgensen
Publisher: CRC Press
ISBN: 1000031721
Category : Technology & Engineering
Languages : en
Pages : 3513
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Book Description
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)
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Author: Shein-Chung Chow
Publisher:
ISBN: 9780815363200
Category : Drug development
Languages : en
Pages : 0
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Book Description
Author:
Publisher:
ISBN:
Category : Academic libraries
Languages : en
Pages : 782
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Book Description
Author: Garrett Fitzmaurice
Publisher: CRC Press
ISBN: 142001157X
Category : Mathematics
Languages : en
Pages : 633
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Book Description
Although many books currently available describe statistical models and methods for analyzing longitudinal data, they do not highlight connections between various research threads in the statistical literature. Responding to this void, Longitudinal Data Analysis provides a clear, comprehensive, and unified overview of state-of-the-art theory
Author: Shein-Chung Chow
Publisher:
ISBN:
Category :
Languages : en
Pages : 0
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Book Description
Author: Shein-Chung Chow
Publisher: CRC Press
ISBN: 9781439822456
Category : Mathematics
Languages : en
Pages : 0
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Book Description
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: Alex Dmitrienko
Publisher: SAS Institute
ISBN: 1635261449
Category : Computers
Languages : en
Pages : 455
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Book Description
Analysis of Clinical Trials Using SAS®: A Practical Guide, Second Edition bridges the gap between modern statistical methodology and real-world clinical trial applications. Tutorial material and step-by-step instructions illustrated with examples from actual trials serve to define relevant statistical approaches, describe their clinical trial applications, and implement the approaches rapidly and efficiently using the power of SAS. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials. Commonly used methods are covered, including dose-escalation and dose-finding methods that are applied in Phase I and Phase II clinical trials, as well as important trial designs and analysis strategies that are employed in Phase II and Phase III clinical trials, such as multiplicity adjustment, data monitoring, and methods for handling incomplete data. This book also features recommendations from clinical trial experts and a discussion of relevant regulatory guidelines. This new edition includes more examples and case studies, new approaches for addressing statistical problems, and the following new technological updates: SAS procedures used in group sequential trials (PROC SEQDESIGN and PROC SEQTEST) SAS procedures used in repeated measures analysis (PROC GLIMMIX and PROC GEE) macros for implementing a broad range of randomization-based methods in clinical trials, performing complex multiplicity adjustments, and investigating the design and analysis of early phase trials (Phase I dose-escalation trials and Phase II dose-finding trials) Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience and the ready-to-use SAS macros compiled in this book.
Author: Alex Dmitrienko, Ph.D.
Publisher: SAS Institute
ISBN: 1629590304
Category : Computers
Languages : en
Pages : 464
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Book Description
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: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 9780849303951
Category : Medical
Languages : en
Pages : 0
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Book Description
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more difficult to conduct and summarize. The Handbook of Bioequivalence Testing offers a complete description of every aspect of bioequivalence testing. Features: Describes the current analytical methods used in bioequivalence testing, as well as their respective strengths and limitations Discusses worldwide regulatory requirements for filing for approval of generic drugs Covers GLP, GCP, and 21 CFR compliance requirements for qualifying studies for regulatory submission and facility certification Includes actual examples of reports approved by regulatory authorities to illustrate various scientific, regulatory, and formatting aspects Provides a list of vendors for the software used to analyze bioequivalence studies and recommendations Explains how to apply for a waiver, how to secure regulatory approval of reports, and how to obtain regulatory certification of facilities conducting bioequivalence studies
