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.