Quantitative Methods for Traditional Chinese Medicine Development
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商品簡介
A comprehensive overview of how to scientifically evaluate of traditional Chinese medicines(TCMs), this book covers regulatory requirements, statistical design, and data analysis for studies conducted in the pharmaceutical/clinical development of TCMs. It discusses issues commonly encountered, including, not limited to, testing for consistency of raw materials, in-process materials, and end products, the preparation of matching placebos in clinical trials, calibration between Chinese diagnostic procedures and well-established Western study endpoints, evidence-based criteria versus experience-based criteria for clinical evaluation, and scientific validity for individualized (personalized) flexible doses.
作者簡介
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 theJournal 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, includingAdaptive 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.
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