Quantitative Methods for Traditional Chinese Medicine Development

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.