1. Introduction
2. Global pharmaceutical development
3. Regulations on traditional Chinese medicine
4. Reference standards and product specifications
5. QOL-like quantitative instrument for evaluation of TCM
6. Factor analysis and principal component analysis
7. Statistical validation of Chinese diagnostic procedures
8. Statistical test for consistency
9. Statistical process for quality control/assurance
10. Bioavailability and bioequivalence
11. Population pharmacokinetics
12. Experience of generic drug products with multiple components
13. Stability analysis for drug products with multiple components
14. Case studies
15. Current issues and recent developments.