Encyclopedia Of Biopharmaceutical Statistics Third Edition

Author : Shein-Chung Chow
Publisher : CRC Press
Page : 0 pages
File Size : 47,5 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 : Shein-Chung Chow
Publisher : Unknown
Page : 0 pages
File Size : 47,6 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 : 2434 pages
File Size : 47,6 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 : 733 pages
File Size : 47,5 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 : 1000 pages
File Size : 51,8 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 : CRC Press
Page : 562 pages
File Size : 47,7 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 : C. Ralph Buncher,Jia-Yeong Tsay
Publisher : CRC Press
Page : 504 pages
File Size : 45,7 Mb
Release : 2019-03-07
Category : Mathematics
ISBN : 9781420056457

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Statistics In the Pharmaceutical Industry by C. Ralph Buncher,Jia-Yeong Tsay Pdf

The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.

Author : Bolton Sanford
Publisher : CRC Press
Page : 776 pages
File Size : 53,9 Mb
Release : 1997-01-17
Category : Business & Economics
ISBN : UOM:39015039921047

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Pharmaceutical Statistics Practical And Clinical Applications, Third Edition by Bolton Sanford Pdf

This edition offers new and expanded information on recent developments in stability data analysis, concepts of statistical outliners, bioequivalence studies, problems in sampling and devising limits for product release, covariance analysis and tolerance intervals, multiple endpoints and clinical data analysis, and more. student price which is available upon request from Marcel Dekker.

Author : James Swarbrick
Publisher : CRC Press
Page : 5536 pages
File Size : 54,9 Mb
Release : 2006-10-25
Category : Medical
ISBN : 084939399X

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Encyclopedia of Pharmaceutical Technology, Third Edition (Print) by James Swarbrick Pdf

Presenting authoritative and engaging articles on all aspects of drug development, dosage, manufacturing, and regulation, this Third Edition enables the pharmaceutical specialist and novice alike to keep abreast of developments in this rapidly evolving and highly competitive field. A dependable reference tool and constant companion for years to come, the Third Edition will offer completely new entries that cover critical issues in the field such as the impact of genomics, biotechnology, and implants on drug discovery, targeting, delivery, and formulation. In addition, it will address new regulatory issues, such as the changes in advertising regulations, and emerging FDA procedures.

Author : James Swarbrick
Publisher : CRC PressI Llc
Page : 128 pages
File Size : 53,5 Mb
Release : 2006-10-01
Category : Medical
ISBN : 0849393973

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Encyclopedia of Pharmaceutical Technology Third Edition (Print/on by James Swarbrick Pdf

Author : Marshall Sittig
Publisher : Unknown
Page : 940 pages
File Size : 55,8 Mb
Release : 1988
Category : Drugs
ISBN : UOM:39015013201754

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Pharmaceutical Manufacturing Encyclopedia by Marshall Sittig Pdf

Organized by generic pharmaceutical, describes the manufacturing process. Data includes the therapeutic function, chemical and common names, raw materials contained, the CAS registry, numbers, plus a world-wide list of trade names and manufacturers.

Author : James E. De Muth
Publisher : CRC Press
Page : 847 pages
File Size : 53,5 Mb
Release : 2020-06-30
Category : Electronic
ISBN : 0367576163

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Basic Statistics and Pharmaceutical Statistical Applications by James E. De Muth Pdf

This popular text covers statistical topics most relevant to those in the pharmaceutical industry and pharmacy practice. It focuses on the fundamentals required to understand descriptive and inferential statistics for problem solving. Incorporating new material in virtually every chapter, this third edition now provides information on software a

Author : Shein-Chung Chow
Publisher : Unknown
Page : 0 pages
File Size : 47,9 Mb
Release : 2018
Category : Drug development
ISBN : 0815363184

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Biopharmaceutical Statistics by Shein-Chung Chow Pdf

Author : Domonic A. Bearfield,Evan M Berman,Melvin J. Dubnick
Publisher : Routledge
Page : 3897 pages
File Size : 52,9 Mb
Release : 2020-08-14
Category : Political Science
ISBN : 9781000031621

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Encyclopedia of Public Administration and Public Policy - 5 Volume Set by Domonic A. Bearfield,Evan M Berman,Melvin J. Dubnick Pdf

Now in its third edition, Encyclopedia of Public Administration and Public Policy remains the definitive source for article-length presentations spanning the fields of public administration and public policy. It includes entries for: Budgeting Bureaucracy Conflict resolution Countries and regions Court administration Gender issues Health care Human resource management Law Local government Methods Organization Performance Policy areas Policy-making process Procurement State government Theories This revamped five-volume edition is a reconceptualization of the first edition by Jack Rabin. It incorporates over 225 new entries and over 100 revisions, including a range of contributions and updates from the renowned academic and practitioner leaders of today as well as the next generation of top scholars. The entries address topics in clear and coherent language and include references to additional sources for further study.

Author : George E. Totten,Rafael Colas
Publisher : CRC Press
Page : 3918 pages
File Size : 55,9 Mb
Release : 2016-01-06
Category : Technology & Engineering
ISBN : 9781466511057

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Encyclopedia of Iron, Steel, and Their Alloys (Online Version) by George E. Totten,Rafael Colas Pdf

The first of many important works featured in CRC Press’ Metals and Alloys Encyclopedia Collection, the Encyclopedia of Iron, Steel, and Their Alloys covers all the fundamental, theoretical, and application-related aspects of the metallurgical science, engineering, and technology of iron, steel, and their alloys. This Five-Volume Set addresses topics such as extractive metallurgy, powder metallurgy and processing, physical metallurgy, production engineering, corrosion engineering, thermal processing, metalworking, welding, iron- and steelmaking, heat treating, rolling, casting, hot and cold forming, surface finishing and coating, crystallography, metallography, computational metallurgy, metal-matrix composites, intermetallics, nano- and micro-structured metals and alloys, nano- and micro-alloying effects, special steels, and mining. A valuable reference for materials scientists and engineers, chemists, manufacturers, miners, researchers, and students, this must-have encyclopedia: Provides extensive coverage of properties and recommended practices Includes a wealth of helpful charts, nomograms, and figures Contains cross referencing for quick and easy search Each entry is written by a subject-matter expert and reviewed by an international panel of renowned researchers from academia, government, and industry. 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 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] International: (Tel) +44 (0) 20 7017 6062; (E-mail) [email protected]