Opis: Quantitative Methods for Traditional Chinese Medicine Development - Shein-Chung Chow

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.Introduction Introduction What Is Traditional Chinese Medicine? Fundamental Differences Basic Considerations for TCM Clinical Trials Practical Issues of TCM Development Globalization of TCM Aim and Scope of the Book Global Pharmaceutical Development Introduction Pharmaceutical Development Process Regulatory Requirements Practical Issues in Drug Development Modernization of TCM Development Regulations on Traditional Chinese Medicine Introduction Regulations on TCM in China Regulations on Herbal Products in Europe Regulations on Herbal Products as Dietary Supplements in the United States Regulations on Herbal Products as Drug Products in the United States Reference Standards and Product Specifications Introduction Reference Standards Product Specifications Product Characterization Practical Issues QOL-Like Quantitative Instrument for Evaluation of TCM Introduction QOL Assessment Performance Characteristics Responsiveness and Sensitivity Utility Analysis and Calibration QOL-Like Instrument for Evaluation of TCM Parallel Assessments Factor Analysis and Principal Component Analysis Introduction Factor Analysis Principal Component Analysis Application of QOL in Hypertensive Patients Statistical Validation of Chinese Diagnostic Procedures Introduction Chinese Diagnostic Procedure Proposed Study Design Calibration of Chinese Diagnostic Procedure Validation of Chinese Diagnostic Procedure A Numerical Example Statistical Test for Consistency Introduction Consistency Index Statistical Quality Control for Consistency Tolerance Region Approach Statistical Process for Quality Control/Assurance Introduction Statistical Model Assessing Consistency for QC/QA An Example Discussion Appendix: Proof of Theorem Bioavailability and Bioequivalence Introduction What Is Bioavailability/Bioequivalence? Bioequivalence Assessment for Generic Approval Drug Interchangeability Controversial Issues Frequently Asked Questions Other Applications Population Pharmacokinetics Introduction Regulatory Requirements Population PK Modeling Design of Population PK An Example Discussion Experience of Generic Drug Products with Multiple Components Introduction In Vivo Single Fasting Bioequivalence Study In Vivo Drug Release Testing Issues on FDA Conjugated Estrogen Bioequivalence Guidance Stability Analysis for Drug Products with Multiple Components Introduction Regulatory Requirements Statistical Model and Methods Stability Designs Stability Analysis for Drug Products with Multiple Active Components Stability Analysis with Discrete Responses Case Studies Introduction Nonclinical Quality by Design Successful TCM Clinical Cases Case Studies of Chinese Herbal Medicines Current Issues and Recent Developments Introduction Critical Issues in TCM Development Frequently Asked Questions from a Regulatory Perspective Recent Developments References Index

Szczegóły: Quantitative Methods for Traditional Chinese Medicine Development - Shein-Chung Chow

Tytuł: Quantitative Methods for Traditional Chinese Medicine Development
Autor: Shein-Chung Chow
Producent: Apple
ISBN: 9781482235999
Rok produkcji: 2015
Ilość stron: 456
Oprawa: Twarda
Waga: 0.77 kg

Recenzje: Quantitative Methods for Traditional Chinese Medicine Development - Shein-Chung Chow