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 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 4057 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 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 Encyclopedia of Biopharmaceutical Statistics written by Shein-Chung Chow and published by . This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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 Encyclopedia of Biopharmaceutical Statistics written by Shein-Chung Chow and published by . This book was released on 2010 with total page 739 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Encyclopedia Of Biopharma Ceutical Statistics written by Shein-Chung Chow and published by CRC Press. This book was released on 2000 with total page 562 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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

Download or read book Encyclopedia of Environmental Management Four Volume Set written by Sven Erik Jorgensen and published by CRC Press. This book was released on 2012-12-13 with total page 3513 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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]

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 245 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 Biopharmaceutical Applied Statistics Symposium written by Karl E. Peace and published by Springer. This book was released on 2018-09-03 with total page 426 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 Nonclinical Statistics for Pharmaceutical and Biotechnology Industries written by Lanju Zhang and published by Springer. This book was released on 2016-01-13 with total page 698 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Encyclopedia of Pharmaceutical Science and Technology Fourth Edition Six Volume Set Print written by James Swarbrick and published by CRC Press. This book was released on 2013-07-01 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical science deals with the whole spectrum of drug development from start to finish. There are many different facets to the pharmaceutical industry, from initial research to the finished product, including the equipment used, trials performed, and regulations that must be followed. Presenting an overview of all of these different aspects, the Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition is a must-have reference guide for all laboratories and libraries in the pharmaceutical field. Bringing together leaders from every specialty related to pharmaceutical science and technology, this is the single-source reference at the forefront of pharmaceutical R&D. The strength of this work is not only its breadth but also the caliber of contributing writers, all experts in their field, writing on all aspects of pharmaceutical science and technology. The fourth edition offers 29 new chapters ranging from biomarkers, computational chemistry, and contamination control to high-throughput screening, orally disintegrating tablets, and quality by design. The encyclopedia details best practices of equipment used, methods for manufacturing, options for packaging, and routes for drug delivery. The volumes also provide a thorough understanding of the choices behind each method. In addition, the regulations, safety aspects, patent guidance, and methods of analysis are presented. Key Areas Covered: Analytics Biomarkers Dosage forms Drug delivery Formulation Informatics Manufacturing Packaging Processing Regulatory affairs Systems validation This is an authoritative reference source for those practicing in any area of pharmaceutical science and technology, enabling the pharmaceutical specialist and novice alike to keep abreast of developments in this constantly evolving and highly competitive field. * Online version coming soon. Contact us 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]

Download or read book Pharmaceutical Statistics written by Sanford Bolton and published by . This book was released on 1990 with total page 680 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Innovative Statistics in Regulatory Science written by Shein-Chung Chow and published by CRC Press. This book was released on 2019-11-18 with total page 553 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Pharmaceutical Statistics Using SAS written by Alex Dmitrienko, Ph.D. and published by SAS Institute. This book was released on 2007-02-07 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.