| ●Editorial | Fujita T | 4-6 |
| ●Drug safety-current status and future perspectives | ||
| 1，Drug safety schemes of prior to marketing | ||
| Safety assessment prior to marketing: The role of non-clinical studies on clinical studies | Fujimori K | 7-22 |
| Clinical Trial Safety Concerns | Uchiyama A | 23-32 |
| 2，Drug safety schemes of post-marketing | ||
| 1）Regulatory agencies' systems for drug safety | ||
| Early post-marketing phase vigilance system for new drugs in Japan | Doi O | 33-41 |
| For safe and effective use of the drug -now and future | Kurokawa T | 43-54 |
| Pharmacovigilance in the United States and its current trends | Usuki H | 55-63 |
| Recent development of pharmacovigilance in the European Union | Suzuki S | 65-70 |
| 2）ADR reporting systems of Japan, US, EU, and WHO | ||
| Spontaneous monitoring system for pharmaceuticals | Kuramochi K | 71-4 |
| An outline of MedWatch in U.S.A. | Yamada A | 75-7 |
| Current situation on the ADR reporting system in the European Union | Suzuki S | 79-84 |
| The WHO Programme for International Drug Monitoring-Looking ahead | Tamiya K, Edwards R | 85-90 |
| 3）Industry and industry-related activities on drug safety | ||
| Post-marketing Surveillance - From the perspective of a Japanese pharmaceutical company | Hirokawa K | 91-9 |
| Safety information handling in US-based pharmaceutical companies in Japan | Watanabe M | 101-5 |
| Drug safety for post marketing - Fron the RAD-AR Council, Japan activity | Shiga N | 107-14 |
| 4）Researchers' activities for drug safety | ||
| The course TIP has followed for 15 years | Beppu H | 115-20 |
| The importance of vigilance by professional citizens: activity of the non-profit organization Japan Institute of Pharmacovigilance | Hama R | 121-6 |
| Prescription-Event Monitoring in the UK and Japan | Kubota K, Sato T | 127-32 |
| Pharmacoepidemipology mission and goal - From new drug development to health care improvement | Sadaike T, Maeda N, Tada H, et al. | 133-45 |
| The Japan Pharmaceutical Association's approaches to ensure the safety of pharmaceuticals -DEM and other programs | Urushibata M, Kouno Y | 147-52 |
| 3，Studies for clinical pharmacokinetics and drug interaction | ||
| Notification from the Ministry of Health, Labor, and Welfare−"Clinical pharmacokinetics of pharmaceuticals" and "Methods for drug interaction studies"− |
Ohno Y | 153-65 |
| ●Review | ||
| Clinical endocrine pharmacology−Including ethnic factors in pharmacodynamics− | Shimizu N | 167-84 |
| EBM questioned−A metascientific criticism | Saio T, Kurihara C | 185-201 |
| ●Material | ||
| Sponsorship, authorship, and accountability | Davidoff F, et al. （trans. by Kurihara C, Mitsuishi T） | 203-9 |
| ●Instructions for authors [English] | 211-6 | |
| ●Editor's note | Shimizu N | 217 |