●Editorial | Kurihara M | 436-7 |
●The 30th Aso-Kuju Conference on Clinical Pharmacology Clinical pharmacology:The past, present, and future Chairman:Sasaguri T,Ohashi K,Nomoto M,Ieiri I, Higuchi S,Hasegawa J,Yamada K,Nakano S | 439-501 | |
Thirty years of Aso-Kuju Conference on Clinical Pharmacology: Past, present and future of clinical pharmacology and therapeutics | Nakano S | 442-50 |
Clinical trials in clinical pharmacology | Ohashi K | 451-3 |
Clinical pharmacology for medical treatments | Nomoto M | 454-8 |
Pharmacology and clinical pharmacology | Sasaguri T | 459-65 |
Center for Advanced Medical Innovation | Hashizume M | 466-70 |
Clinical pharmacology education in the faculty of pharmaceutical sciences | Ieiri I | 471-4 |
Good journal and good article: clinical trial registry and CONSORT statement | Tsutani K | 475-84 |
Publication ethics and publication bias | Yamazaki S | 485-90 |
Major database for clinical trials and clinical practice guidelines in Japan | Uchida E | 491-6 |
Discussion | 497-8 | |
Scientific session 1, 2 | 499-500 | |
●First-in-Human Trial Seminar & Workshop: An MHLW Core Hospital Seminar, supported by MHLW grant for promoting clinical research Organized by:General Clinical Research Center, Oita University Hospital, Clinical Pharmacology Center, Oita University Hospital | 503-46 | |
Government policies for first-in-human study in Japan | Sato T | 505-10 |
Impact of exploratory investigational new drug studies in drug development | Tsuji A | 511-8 |
Non-clinical toxicity study for human initial administration | Onodera H | 519-26 |
Rheumatoid arthritis (RA) | Kishi J | 527-35 |
Workshop and plenary discussion | 536-46 | |
●CDISC as the global standards | ||
History, current status and future scope of CDISC as the global standards -Interview with Dr. Kush, the President of CDISC- | Kush RD,Fukushima M,Takenouchi K,et al. | 547-57 |
CDISC outline and strategic goals | Takenouchi K | 559-61 |
Global approach to accelerating medical research | Kush RD | 563-88 |
●Interview | ||
Novel strategies of early phase drug development: RapidFACT, iv-Microtracer, and microdosing-Interview with Dr. Lloyd Stevens- ・Full text version in English is here ! | Stevens L (Interview and trans. by Kurihara C,Saio T. Supervised by Inoue T) | 589-600 |
●Articles | ||
Present situations and future of the educational environment for the clinical development in Japan: A study based on a questionnaire survey | Somekawa L,Kurokawa T | 601-11 |
The importance of personalized drug safety information: Revaluation of
the ADR causal assessment in pharmacovigilance towards good pharmacoepidemiological studies | Suzuki S | 613-36 |
●Forum | ||
Report of “Basic and practical workshop of regulatory affairs for clinical research in academia” supported by the Coordination, Support and Training Program for Translational Research, MEXT | Myoui A,Ando T | 637-40 |
Neuroethics and the historical overview of psychiatric ethics | Imamura O,Mima T | 641-7 |
●Instructions for authors [Japanese] & [English] | 649-57 | |
●Editor's note | Gotoh E | 659 |