1. Editor’s Note

   • Herng-Der Chern

   Good Regulatory Science in Asia/pacific: Part 1 30 December 2009 Pages: 1 - 2

2. Bridging Studies in Japan and Taiwan: A Dynamic Evolution in Regulating Ethnic Differences

   • Wen-Hua Kuo

   Good Regulatory Science in Asia/Pacific: Part 1 30 December 2009 Pages: 3 - 10

3. A Noninferiority Test for Treatment-by-Factor Interaction with Application to Bridging Studies and Global Trials

   • Jen-pei Liu
   • Jr-Rung Lin
   • Eric Hsieh

   Good Regulatory Science in Asia/Pacific: Part 1 30 December 2009 Pages: 11 - 16

4. The Australian Medicines Regulatory System: A Risk-Based Approach to Regulation

   • Rohan Hammett
   • Leonie Hunt

   Good Regulatory Science in Asia/Pacific: Part 1 30 December 2009 Pages: 17 - 20

5. Collaboration between Japan and Other Asian Countries in New Drug Development: Japanese Industry Perspective

   • Kohei Wada

   Good Regulatory Science in Asia/Pacific: Part 1 30 December 2009 Pages: 21 - 26

6. Bridging Study versus Prespecified Regions Nested in Global Trials

   • Sue-Jane Wang

   Good Regulatory Science in Asia/Pacific: Part 1 30 December 2009 Pages: 27 - 34

7. The Role of the Asia-Pacific Region in Global Drug Development Strategy

   • S. Edmund Tsuei

   Good Regulatory Science in Asia/Pacific: Part 1 30 December 2009 Pages: 35 - 40

8. Current Drug Regulatory Status of Advanced Drug Evaluation System in Korea

   • In-Sook Pork
   • Dong Sup Kim

   Good Regulatory Science in Asia/Pacific: Part 1 30 December 2009 Pages: 41 - 46

9. Recent Approaches by the PMDA to Promoting New Drug Development: Change in the Status of the PMDA in Relation to New Drug Development over the Last Five Years

   • Kazuhiko Mori
   • Sotoshi Toyoshima

   Good Regulatory Science in Asia/Pacific: Part 1 30 December 2009 Pages: 47 - 55

10. Clinical Trials in Southeast Asia: An Update

    • Ellick Wong

    Good Regulatory Science in Asia/Pacific: Part 1 30 December 2009 Pages: 57 - 61

11. Updates on IND Process and Clinical Trials Status in Taiwan

    • Jon-Jih Lido
    • Chi-Chou Liao
    • Min-Shung Lin

    Good Regulatory Science in Asia/Pacific: Part 1 30 December 2009 Pages: 63 - 68

12. Standard Operating Procedures (SOPs): Why Companies Must Have Them, and Why They Need Them

    • Janet Gough
    • Michael Hamrell

    Continuing Education 30 December 2009 Pages: 69 - 74

13. Stringent Laws and Regulations for Dietary Supplements

    • Tao Jiang
    • Shu Zhang

    Regulatory Affairs 30 December 2009 Pages: 75 - 81

14. Statistical Validation of Traditional Chinese Diagnostic Procedures

    • Chin-Fu Hsiao
    • Hsiao-Hui Tsou
    • Shein-Chung Chow

    Statistics 30 December 2009 Pages: 83 - 95

15. Nonclinical Testing of Vaccines: Report from a Workshop

    • Jan Willem van der Laan
    • Roy Forster
    • Andrée Penninks

    Workshop Report 30 December 2009 Pages: 97 - 107

16. A Review of Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials

    • David M. Cocchetto

    Book Review 30 December 2009 Pages: 109 - 110