Chow Quantitative Methods for Traditional Chinese Medicine Development

Erscheinungsjahr 2015
ISBN: 978-1-4822-3600-2
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 456 Seiten

Reihe: Chapman & Hall/CRC Biostatistics Series

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.

Autoren/Hrsg.

Chow, Shein-Chung

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizin, Gesundheit: Sachbuch, Ratgeber
• Mathematik | Informatik Mathematik Stochastik
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie

Inhaltsverzeichnis

Introduction. Global Pharmaceutical Development. Regulatory Requirements. Product Specification and Reference Standards. 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/Bioequivalence. Population Pharmacokinetics. Experience in Generic Drug Products with Multiple Components. Design and Analysis of TCM Clinical Trials.