Quantitative Methods for Traditional Chinese Medicine Development

ISBN-13: 9781482235999 / Angielski / Twarda / 2015 / 430 str.

Shein-Chung Chow

Opis

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:

• Scientists and researchers who are engaged in pharmaceutical/clinical research and development of TCMs
• Those in regulatory agencies who make decisions in the review and approval process of TCM regulatory submissions
• 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

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 regulatory perspective."

Spis treści

Introduction. Global Pharmaceutical Development. Regulations on Traditional Chinese Medicine. Reference Standards and Product Specifications. QOL-Like Instrument for Evaluation of TCM. Factor Analysis and Principal Component Analysis. Statistical Validation of Chinese Diagnostic Procedures. Statistical Test for Consistency. Statistical Process for Quality Control/Assurance. Bioavailability and Bioequivalence. Population Pharmacokinetics. Experience of Generic Drug Products with Multiple Components. Stability Analysis for Drug Products with Multiple Components. Case Studies. Current Issues and Recent Developments.

O autorze

Shein-Chung Chow, PhD, is a professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. Dr. Chow is also an adjunct professor at Duke–National University of Singapore Graduate Medical School, an adjunct professor at North Carolina State University, and founding director of the Global Clinical Trial and Research Center in Tianjin, China. He is editor-in-chief of the Journal of Biopharmaceutical Statistics and editor-in-chief of the Chapman & Hall/CRC Biostatistics Series. He is the author or co-author of more than 250 papers and 24 books, including Adaptive Design Methods in Clinical Trials, Second Edition, Handbook of Adaptive Designs in Pharmaceutical and Clinical Development, and Controversial Statistical Issues in Clinical Trials. A fellow of the ASA and member of the ISI, Dr. Chow has received the ASA Chapter Service Recognition Award, the DIA Outstanding Service Award, and the ICSA Extraordinary Achievement Award.