| ●Editorial | Sugiyama Y | 586-7 |
| ●Microdosing clinical trials of biologics | ||
| Future prospects of microdosing and exploratory investigational new drug
clinical trials of biologics：Pharmacokinetics and dose-setting |
Kato M，Sugiyama Y | 589-603 |
| Short report on microdose clinical trials for biological products | Yano T，Watanabe Y | 605-10 |
| Quality and safety issues of biotechnological products used in early clinical studies | Yamaguchi T， Ishii-Watanabe A |
611-27 |
| Microdose and exploratory investigational new drug clinical trials for
antibodies： Starting dose setting for first in human study |
Nakazawa T，Arai H， Ishii Y，et al. |
629-38 |
| Clinical application of molecular imaging in oncology ─ Introduction
of research activity supported by the Grant-in-Aid for Cancer Research ─ |
Inoue T，Senda M，Saga T， et al. |
639-50 |
| ●What are antibody drugs?：Science and marketing | ||
| Is antibody drug discovery in Japan a bubble? | Masuho Y | 651-81 |
| Trend of antibody therapeutics and strategies for Japanese pharmaceutical companies | Inoue R | 683-94 |
| ●Articles | ||
| An Academic Network for Trial in Clinical Pharmacology ─ Present status and future ─ | Tateishi T，Uchida E， Ohashi K，et al. | 695-702 |
| Clinical trial environment in Japan：The perspective of sponsor companies for improvement of clinical trial execution |
Wakayama N，Kaji H， Nishimura Y，et al. |
703-16 |
| Unveiling the secret of the IOM report“To Err is Human”：what we Japanese have not known yet |
Saio T | 717-24 |
| Research study on the feasibility of testing for detection of life-style related diseases by a self-blood collection kit at pharmacies | Shimizu N，Notani J， Kitayama H，et al. | 725-46 |
| ●Article and material | ||
| Ethical regulations and standardized operating procedure for research involving humans ─ A basis for promoting molecular imaging and translational clinical research─ |
Kurihara C，Fukushima Y， Inano A，Yanai K |
747-84 |
| Explanatory review of the FDA guidance on adverse event reporting to IRBs | Kurihara C | 785-6 |
| Guidance for clinical investigators, sponsors, and IRBs Adverse event reporting to IRBs ─ Improving human subject protection U.S. Department of Health and Human Services，Food and Drug Administration （FDA），Office of the Commissioner（OC），et al. |
(trans.by Kurihara C) | 787-95 |
| ●Manual for diagnosis of Adverse Drug Event | Shimizu N | 797-850 |
| ●Forum | ||
| Problem of the unavailability of MicroFine Plus 29G12.7mm and intramuscular injection of Growth-hormone |
Kamada I | 851-6 |
| Shitamachi Highball, wonderful drink in downtown | Itoh K | 857-60 |
| ●Instructions for authors [Japanese] & [English] | 861-6 | |
| ●Editor's note | Kageyama S | 867 |