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| 序 文 | 竹内正弘（Masahiro Takeuchi） Stephen W.Lagakos | iii |
| Faculty Members | iv-vii | |
| Program | viii-xii | |
| Opening Remarks and Welcoming Address | 佐藤登志郎（Toshiro Sato） | 1 |
| Delcan P.Doogan | 3 | |
| Congratulatory Remarks | 林 憲一（Yoshikazu Hayashi） | 5-6 |
| SESSION 1: SIMULTANEOUS/WORLDWIDE DEVELOPMENT STRATEGIES: OVERVIEW | Session Chairperson: 矢崎義雄（Yoshio Yazaki） | 7-79 |
| Several Years Experience on Bridging Studies and the Future | 藤原康弘（Yasuhiro Fujiwara） | 9-24 |
| CLINICAL UPDATE IN ASIA | ||
| Evaluation of Ethnic Sensitivity in Taiwan and the Related Issues of Statistical Consideration | Chien-Hua Wu | 25-35 |
| Experience in Korea on Bridging Studies | In-Jin Jang | 37-47 |
| Pharmacogenetics of Antipsychotic Drug Response | Anil K. Malhotra | 49-59 |
| How Does Difference in Medical Practice in Japan and the Rest of the World Affect Drug Development? | 村崎光邦（Mitukuni Murasaki） | 61-4 |
| How Scientific is Placebo Use? | 石郷岡 純（Jun Ishigooka） | 65-72 |
| Panel Discussion | 73-9 | |
| SESSION 2: SIMULTANEOUS/WORLDWIDE DEVELOPMENT STRATEGIES: NEW CHALLENGIES | Session Chairperson: 井村裕夫（Hiroo Imura） | 81-122 |
| New Approches of Dose Range Finding | 谷川原祐介（Yusuke Tanigawara） | 83-93 |
| Role of Surrogate Markers in Psychiatry -Imaging of neurotransmitter binding sites with PET- | 武井教使（Noriyoshi Takei） | 95-102 |
| The Search for Alternatives to Randomized Comparative Studies | Peter Boyle | 103-12 |
| Panel Discussion | 113-22 | |
| SESSION 3: SIMULTANEOUS/WORLDWIDE DEVELOPMENT STRATEGIES: ICH-E5 | Chaired by Stephen W. Lagakos | 123-61 |
| Update and Progress on ICH E5: Report from the meeting of February, 2002 in Brussels and September, 2002 in Washington DC | Robert T. O'Neill | 125-33 |
| Use of Foreign Data for Drug Approval | Ann Farrel | 135-41 |
| Panel Discussion Implementation of the E5 Guideline: Status and Next Steps | Caroline N. Loew | 143-5 |
| Issues for Simultaneous Global Drug Development | Michael J. Ferris | 147-9 |
| E5 GL Evolves from a Conjecture (or a Grand Excuse) to a Solid Ground | 小野俊介（Shunsuke Ono） | 151-3 |
| Discussion | 155-61 | |
| SESSION 4: MORE CONCRETE PLAN AND ACTIONS BASED ON ICH AGREEMENT, APEC REPORT AND TODAY'S DISCUSSION | Session Chairperson: 竹内正弘（Masahiro Takeuchi） | 163-92 |
| Genetics as a Means of Understanding Intrinsic Ethnic Differences -genetic variation on metabolism/ transporter/ receptor- | 東 純一（Junichi Azuma） | 165-82 |
| Workshop: Short summary and action plan aiming at simultaneous worldwide development | 183-92 | |
| SESSION 5: PHARMACOGENOMICS: DRUG DISCOVERY AND DRUG DEVELOPMENT BASED ON THE GENETIC ANALYSIS | Session Chairperson: 鎌滝哲也（Tetsuya Kamataki） | 193-253 |
| New Monoclonal Antiboby Approved for Advanced Breast Cancer: Trastuzumab | 仁平新一（Sin-ichi Nihira） | 195-204 |
| The Human Approach to Target Validation and Drug Discovery | Alstair J. Riddell | 205-17 |
| From Genomics to Drugs -gene haplotypes and drug response- | Kevin Rakin | 219-28 |
| Toxicogenomics in the USA -molecular toxicological approach in drug discovery and development- | 堀井郁夫（Ikuo Horii） | 229-38 |
| Regenerative Medicine | 笹井芳樹（Yoshiki Sasai） | 239-47 |
| Panel Discussion | 249-53 | |
| SESSION 6: IMPLEMENTATION OF GLOBAL DEVELOPMENT PROGRAMS | Chaired by Declan P. Doogan | 255-89 |
| Drug Development in Asia -an industry perspective- | Stephen Uden | 257-65 |
| Lessons Learned from a Global Clinical Trial -an experience of 'RENAAL' study- | 黒川 清（Kiyoshi Kurokawa） | 267-78 |
| Experience of a Japan/ Korea Regional Trial | Henk J. de Koning Gans | 279-89 |
| SUMMARY AND CONCLUSION | 291-308 | |
| Summary and Conclusion | Stephen W. Lagakos | 293-9 |
| Closing Remarks | 竹内正弘（Masahiro Takeuchi） | 301-8 |