| ●Editorial | Kurokawa T | 4 |
| ●ICH-S7B, E14: The notifications in Japan and their impact on new drug development | ||
| Implementation of the ICH E14 guideline in Japan and future directions in assessment of proarrhythmic risk in drug development | Shinagawa K, Uyama Y | 5-12 |
| Thorough QT/QTc study and safety of human subjects | Suzuki-Nishimura T | 13-21 |
| Cardiac safety evaluation by QT interval in Japan | Kumagai Y | 23-39 |
| A thorough QT/QTc study: Actual study case based on the ICH E14 and proposals for Japanese pharmaceutical companies | Hayashi T | 41-9 |
| ICH S7B (for non-clinical studies) and E14 (for clinical studies) regarding evaluation of abnormal ECGs - Significance of the MHLW notification - | Hombo T | 51-6 |
| ●The 28th Aso-Kujyu Conference on Clinical Pharmacology | ||
| Chairman: Higuchi S, Ohashi K, Nomoto M, Sasaguri T, Nakano S, Hasegawa J, Yamada K | 57-175 | |
| Opening remarks | Higuchi S | 59 |
| Translational Research in Japan | Saruta T | 60-77 |
| Contribution of clinical pharmacology to translational research | Watanabe H | 78-96 |
| Translational research based on PGx | Tsujimoto G | 97-110 |
| The CCR4 as a novel-specific molecular target for immunotherapy in lymphoma | Ishida T | 111-30 |
| Discussion | 131-2 | |
| Drug absorption controlled by intestinal influx transporters | Tamai I | 133-52 |
| Effects of fruit juices and genetic polymorphism on the function of organic anion transporting polypeptides (OATPs) | Kotegawa T | 153-9 |
| Role of efflux transporters in the intestinal drug absorption | Ieiri I | 160-73 |
| Closing remarks | Nomoto M | 174 |
| ●Article | ||
| Regulatory Science Wars: Confused concepts and incompetence of academics on science studies | Saio T, Kurihara C | 177-88 |
| ●Translations and article | ||
| Guideline on Human Cell-Based Medicinal Products | ||
| European Medicines Agency (EMEA), Committee for Medicinal Products for Human Use (CHMP) | (trans. by Nishikawa A, Murayama T) | 189-211 |
| Reflection Paper on Pharmacogenomic Samples, Testing and Data Handling | ||
| European Medicines Agency (EMEA), Committee for Medicinal Products for Human Use (CHMP) | (trans. by Nishikawa A, Murayama T) | 213-20 |
| Improving the readability of information for study subjects: The Dutch approach | Uchida E, Kawamura Y, Uchida N, et al. | 221-5 |
| Hoe te komen tot leesbare informatie aan de proefpersoon? Advies PIF-werkgroep aan de CCMO | (trans. by Arnold FL, Kawamura Y, Hibino F, et al.) | 227-34 |
| Model informatiebrief Met voorbeeldpassages en toestemmingsformulieren | (trans. by Arnold FL, Kawamura Y, Hibino F, et al.) | 235-43 |
| ●Forum | ||
| Greek economic crisis and drug price cut | Saio T | 245-8 |
| ●Instructions for authors [Japanese] & [English] | 249-54 | |
| ●Editor's note | Shimizu N | 255 |