| ●Editorial | Tsubaki H | 342-4 |
| ●Risk management of pharmaceuticals−product management and project management− | ||
| Round table discussion：Various risks surrounding pharmaceutical development and pharmaceutical products | Hirayama Y, Kumakawa T, Iizuka Y, et al. | 345-74 |
| 5th anniversary symposium of the Department of Pharmacoepidemiology, Kyoto University School of Public Health−Mission and perspectives in pharmacoepidemiology− | 375-442 | |
| Organized and edited by Department of Pharmacoepidemiology, Kyoto University School of Public Health, Supervised by：Fukushima M | ||
| Guidance documents by ICH, FDA, CIOMS on pharmaceutical risk management -explanatory review | Kurihara C, Shimizu N | 443-56 |
| Pharmacogenomics and Drug-Diagnostic Co-Development： The implications of the U. S. FDA Guidance on pharmacogenomics | Fukagaya K, Kurihara C, Yonemoto S | 457-66 |
| The EU Human Tissue Directive and the world situation of quality assurance of human body parts：A proposal of"Bioethics Audit"to be initiated in Japan | Yonemoto S, Fukagaya K, Kurihara C | 467-72 |
| Will priority medicines come true?：A critical reflection | Saio T | 473-82 |
| Best Evidence Pharmacy Education (BEPE): a proposition of EBM to pharmacy education | Saio T, Hirata T, Matsumoto K, et al. | 483-90 |
| Turmoil of the market and conflicts of interest in complementary and alternative medicine | Tsukayama H, Yamashita H | 491-503 |
| ●Topics | ||
| Key issues in support of investigator-initiated clinical trials | Arakawa Y | 505-12 |
| ●Material | ||
| From translational research to Critical Path Research | Murayama T | 513-5 |
| Innovation・Stagnation Challenge and Opportunity on the Critical Path to New Medical Products |
U.S. Department of Health and Human Services, Food and Drug Administration (trans.by Nishikawa A, Asahara M, Murayama T, et al.) | 517-41 |
| FDA Guidance for Industry "Pharmacogenomics Data Submission" and its collaterals - A Japanese translation | (trans. by Azuma J, Quintiles Transnational Japan KK) | 543-618 |
| Notification on the Pharmacogenomic Data Submissions | Ministry of Health, Labor and Welfare | 619-22 |
| Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. | (trans. by Yonemoto S) | 623-32 |
| New Drugs for Neglected Diseases：From Pipeline to Patients | Pécoul B (trans. by Hirabayashi F) | 633-8 |
| Is This Clinical Trial Fully Registered?： A Statement from the International Committee of Medical Journal Editors | De Angelis C, Drazen JM, Frizelle FA, et al. (trans. by Saio T, Mitsuishi T, Fukushima M) | 639-42 |
| Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies | Smith R (trans. by Saio T, Mitsuishi T, Fukushima M) | 643-8 |
| ●Forum | ||
| On the myth of mega trials | Yokota Y | 649-53 |
| In the beginning was the Word | Yokota Y | 653-4 |
| A book review; On the Take | Nakajima A | 654-5 |
| ●Instructions for authors [English] | 657-62 | |
| ●Editor's note | Kurihara M | 663 |