Innovative Statistics in Regulatory Science (Chapman & Hall/CRC Biostatistics Series)

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. <ul>
<li>Devoted entirely to discussing statistics in regulatory science for pharmaceutical development.</li> <li>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.</li> <li>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.</li> <li>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.</li> <li>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).</li> </ul> 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 &amp; Francis, New York. Dr. Chow is the author or co-author of over 300 methodology papers and 30 books.

Chow, Shein-Chung

Reference

Chapman and Hall/CRC

Quantitative Methods for Traditional Chinese Medicine Development (Chapman & Hall/CRC Biostatistics)

A Western-Based Approach to Analyzing TCMs In recent years, many pharmaceutical companies and clinical research organizations have been focusing on the development of traditional Chinese (herbal) medicines (TCMs) as alternatives to treating critical or life-threatening diseases and as pathways to personalized medicine. Quantitative Methods for Traditional Chinese Medicine Development is the first book entirely devoted to the design and analysis of TCM development from a Western perspective, i.e., evidence-based clinical research and development. The book provides not only a comprehensive summary of innovative quantitative methods for developing TCMs but also a useful desk reference for principal investigators involved in personalized medicine. Written by one of the world's most prominent biostatistics researchers, the book connects the pharmaceutical industry, regulatory agencies, and academia. It presents a state-of-the-art examination of the subject for: <ul> <li>Scientists and researchers who are engaged in pharmaceutical/clinical research and development of TCMs</li> <li>Those in regulatory agencies who make decisions in the review and approval process of TCM regulatory submissions</li> <li>Biostatisticians who provide statistical support to assess clinical safety and effectiveness of TCMs and related issues regarding quality control and assurance as well as to test for consistency in the manufacturing processes for TCMs</li> </ul> This book covers all of the statistical issues encountered at various stages of pharmaceutical/clinical development of a TCM. It explains regulatory requirements; product specifications and standards; and various statistical techniques for evaluation of TCMs, validation of diagnostic procedures, and testing consistency. It also contains an entire chapter of case studies and addresses critical issues in TCM development and FAQs from a

Quantitative Methods for Traditional Chinese Medicine Development (Chapman & Hall/Crc Biostatistics)

Health, Fitness & Dieting

Alternative Medicine

As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator’s biologic products. But scientific challenges remain due to the complexity of both the manufacturing process and the structures of biosimilar products.
 Written by a top biostatistics researcher, Biosimilars: Design and Analysis of Follow-on Biologics is the first book entirely devoted to the statistical design and analysis of biosimilarity and interchangeability of biosimilar products. It includes comparability tests of important quality attributes at critical stages of the manufacturing processes of biologic products. 
 Connecting the pharmaceutical/biotechnology industry, government regulatory agencies, and academia, this state-of-the-art book focuses on the scientific factors and practical issues related to the design and analysis of biosimilar studies. It covers most of the statistical questions encountered in various study designs at different stages of research and development of biological products.

Biosimilars: Design and Analysis of Follow-on Biologics (Chapman & Hall/CRC Biostatistics Series)

Science & Math

Mathematics

"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."

Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls, and Stability (Statistics: Textbooks and Monographs)

Liu, Jen-Pei

CRC-Press

Innovative Methods for Rare Disease Drug Development (Chapman & Hall/CRC Biostatistics Series)

"In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition that affects less than 200,000 persons. For approval of "orphan" drug products for rare diseases, the traditional approach of power analysis for sample size calculation is not feasible because there are only limited number of subjects available for clinical trials. In this case, innovative approaches are needed for providing substantial evidence meeting the same standard as drugs in common conditions with certain statistical assurance. Innovative Methods for Rare Diseases Drug Development focuses on biostatistical applications in terms of design and analysis in pharmaceutical research and development from both regulatory and scientific (statistical) perspectives"--

In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition that affects fewer than 200,000 persons. For the approval of "orphan" drug products for rare diseases, the traditional approach of power analysis for sample size calculation is not feasible because there are only limited number of subjects available for clinical trials. In this case, innovative approaches are needed for providing substantial evidence meeting the same standards for statistical assurance as drugs used to treat common conditions. Innovative Methods for Rare Disease Drug Developmentfocuses on biostatistical applications in terms of design and analysis in pharmaceutical research and development from both regulatory and scientific (statistical) perspectives. 
Key Features: 
Reviews critical issues (e.g., endpoint/margin selection, sample size requirements, and complex innovative design). 
Provides better understanding of statistical concepts and methods which may be used in regulatory review and approval. 
Clarifies controversial statistical issues in regulatory review and approval accurately and reliably. 
Makes recommendations to evaluate rare diseases regulatory submissions. 
Proposes innovative study designs and statistical methods for rare diseases drug development, including n-of-1 trial design, adaptive trial design, and master protocols like platform trials. 
Provides insight regarding current regulatory guidance on rare diseases drug development like gene therapy.

Controversial Statistical Issues in Clinical Trials (Chapman & Hall/CRC Biostatistics Series)

Routledge

Statistical Design and Analysis of Stability Studies (Chapman & Hall/CRC Biostatistics Series)

The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies.\nAfter introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies.\nTo ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development.

Sample Size Calculations in Clinical Research (Chapman & Hall/CRC Biostatistics Series)

Praise for the Second Edition: 
"… this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics\n"This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered …" – Journal of the Royal Statistical Society\nSample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation.\nFeatures:\nCompares the relative merits and disadvantages of statistical methods for sample size calculations\nExplains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages\nPresents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women’s health\nProvides sample size calculations for dose response studies, microarray studies, and Bayesian approaches\nThis new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation.

Shao, Jun

Wang, Hansheng

Lokhnygina, Yuliya

Biological Sciences

Analytical Similarity Assessment in Biosimilar Product Development

This book focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It covers concepts such as the tiered approach for assessment of similarity of critical quality attributes in the manufacturing process of biosimilar products, models/methods like the statistical model for classification of critical quality attributes, equivalence tests for critical quality attributes in Tier 1 and the corresponding sample size requirements, current issues, and recent developments in analytical similarity assessment.

See the best price to sell, buy, or rent books by Chow, Shein-Chung. BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

Books by Chow, Shein-Chung

See the best price to sell, buy, or rent books by Chow, Shein-Chung. BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

Innovative Statistics in Regulatory Science (Chapman & Hall/CRC Biostatistics Series)

Quantitative Methods for Traditional Chinese Medicine Development (Chapman & Hall/Crc Biostatistics)

Biosimilars: Design and Analysis of Follow-on Biologics (Chapman & Hall/CRC Biostatistics Series)

Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls, and Stability (Statistics: Textbooks and Monographs)

Innovative Methods for Rare Disease Drug Development (Chapman & Hall/CRC Biostatistics Series)

Innovative Methods for Rare Disease Drug Development (Chapman & Hall/CRC Biostatistics Series)

Controversial Statistical Issues in Clinical Trials (Chapman & Hall/CRC Biostatistics Series)

Statistical Design and Analysis of Stability Studies (Chapman & Hall/CRC Biostatistics Series)

Sample Size Calculations in Clinical Research (Chapman & Hall/CRC Biostatistics Series)

Analytical Similarity Assessment in Biosimilar Product Development