| ●Editorial | Kurihara M | 6-7 | Full text | |
| ●The 33rd Aso-Kujyu Conference on Clinical Pharmacology | 9-57 | Abstract | ||
| Organizers：Ieiri I，Ohashi K，Nomoto M，Sasaguri T，Nakano S，Higuchi S，Yamada K，Hasegawa J，Sendo T | ||||
| Experience of a reviewer in Japanese new drug approvals | Kodama Y | 12-6 | ||
| Education of drug safety | Masada M | 17-24 | ||
| The new role of academia in drug development | Uchiyama M | 25-31 | ||
| Information literacy using PMDA in our community pharmacy | Kato M | 32-8 | ||
| Dose selection of solanezumab by utilizing PK/PD modeling | Uenaka K | 39-45 | ||
| Application of PPK/PD modeling in anti-osteoporotic drug development | Hasegawa C | 46-50 | ||
| PPK/PD approach for drug development | Kijima S | 51-56 | ||
| ●Consolidated Strategic Meeting on Development of Next-generation Cancer Molecular-targeted Therapy | 59-144 | Abstract | ||
| Chairman of Organizing Committee & Steering Committee：Yoshikawa
T Organized by：Organizing Committee of the Consolidated Strategic Meeting on Development of Next-generation Cancer Molecular-targeted Therapy；Kyoto Prefectural University of Medicine |
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| Opening remarks | Yoshikawa T | 62 | ||
| Greetings | Suematsu M | 63 | ||
| Congratulations | Shiozaki Y Yamada K Sato A | 64 65 66 | ||
| New initiative for medical research and development | Hishiyama Y | 67-74 | ||
| Cancer medical care and research in era of innovation | Hotta T | 75-81 | ||
| Development of new molecular targeting agent: New cutting edge oncology research and making its infrastructure | Ohtsu A | 82-9 | ||
| Targeting essential growth drivers in cancer | Mano H | 90-96 | ||
| Development of the first antibody-drug against neoplasia originating from Japan | Ueda R | 97-105 | ||
| Discovery of a novel MEK inhibitor trametinib (trade name Mekinist) discovered by “RB-reactivator screening” | Sakai T | 106-13 | ||
| Cancer immunotherapy by antibody | Honjo T | 114-22 | ||
| Academia-initiated drug development in Japan | Noda T | 123-8 | ||
| Toward collaboration between Japan Cancer Research Project and Drug Discovery Support Network | Kurebayashi Y | 129-31 | ||
| Panel discussion Chaired by Nakanishi Y，Fukushima M | 132-44 | |||
| ●The 2nd Translational Research Center Workshop： Success and challenge of translational research centers in US and Japan | 145-88 | Abstract | ||
| Organized by：Ministry of Education, Culture, Sports, Science and Technology | ||||
| Opening remarks: Welcome to this workshop | Saruta T | 147-8 | ||
| Guest speech: AMED: Mission to empower a science of uncertainty and an art of probability | Suematsu M | 149-53 | ||
| Out of many: One Harvard Catalyst－Success and challenges of the Harvard TR Center－ | Weisel L | 154-9 | ||
| Successes and challenges of the Medical University South Carolina Clinical and Translational Research Institute | Halushka PV，Brady K， Davis R，Sampson R | 160-8 | ||
| Discussion | 169-70 | |||
| National infrastructure for promoting made-in-Japan medical innovation | Nagai Y | 171-4 | ||
| Success and challenge of Hokkaido University TR Center | Sato N | 175-7 | ||
| Development of medical devices through biomedical engineering collaboration at Tohoku University | Shimokawa H | 178-80 | ||
| Challenge and achievement of Institute for Advancement of Clinical and
Translational Science, Kyoto University Hospital | Shimizu A | 181-3 | ||
| Current approach for global expansion of innovative medicine in Osaka University | Sawa Y | 184-7 | ||
| Closing remarks | Fukushima M | 188 | ||
| ●Symposium in the 135th Annual Meeting of the Pharmaceutical Society of Japan The challenge of developing new treatments for NTDs originating from Japan | 189-233 | Abstract | ||
| Organizers：Kita K，Yamada H | ||||
| The challenge of developing new treatments for NTDs originating from Japan | Yamada H | 192-3 | Full text | |
| The global situation of Neglected Tropical Diseases | Ichimori K | 194-8 | Full text | |
| Current situation of drug development for Neglected Tropical Diseases (NTDs) | Kita K | 199-204 | Full text | |
| International partnership for therapeutic drug development of NTDs by DNDi | Yamada H，Hirabayashi F， Brunger C | 205-10 | Full text | |
| Development of and access to NTD medicines－Efforts as a pharmaceutical company－ | Asada M | 211-8 | Full text | |
| Activity of NTDs Drug-discovery Research Consortium | Namatame I | 219-24 | Full text | |
| Japan’s challenge for Neglected Tropical Diseases (NTDs) －With a point of view from Ministry of Health, Labour and Welfare－ | Hinoshita E | 225-8 | Full text | |
| Panel discussion | 229-31 | Full text | ||
| Closing remarks | Kita K | 232-3 | Full text | |
| ●Interview (translation) | ||||
| Interview with Dr. Louis B. Jacques on insurance coverage policy of CMS focusing PET imaging | Jacques LB （Int. and trans. by Kurihara C） | 235-46 | Abstract | |
| ●Translation | ||||
| Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception | FDA-CBER （trans. by Nishimura H，Kimura Y） | 247-51 | Full text | |
| ●Instructions for authors［Japanese］＆［English］ | 253-61 | Full text | ||
| ●Editor’s note | Nudeshima J | 263 | Full text | |
| ［Electronic publications only］ | ||||
| ●Articles | ||||
| Information usage of patients with muscular dystrophy about clinical trials and its challenge | Noguchi S，Sato H | 265-79 W91-W105 | Full text | |
| The role of suvorexant as shown by the findings of clinical trials | Oda H | 281-9 W1-W9 | Full text | |
| Considering the future of clinical research at the turning point of implementation of the new legislation in Japan－Proposal Part 1－ Relationship between the new legislation for clinical research and the existing regulatory system |
Ohshima H，Aoyagi M， Koike R，et al． |
291-305 W11-W25 |
Full text | |
| Considering the future of clinical research at the turning point of implementation of the new legislation in Japan－Proposal Part 2－ iSACRA: New regulation of Clinical Trial Applications |
Aoyagi M，Ohshima H， Koike R，et al． |
307-16 W27-W36 |
Full text | |
| ●Interview | ||||
| Interview with Dr. Louis B. Jacques on insurance coverage policy of CMS
focusing PET imaging －Scientific evidence and social, ethical implications concerning healthcare reimbursement－ | Jacques LB （Interview by Kurihara C） | 317-28 W73-W84 | Full text | |
| ●PET drug regulations in the U.S. | ||||
| Translation：The trend of U.S. regulations concerning PET examination | Kurihara C | 329-37 W37-W45 | Full text | |
| Translation：New regulations of PET drugs in the U.S. and the trends in FDA approvals －PET Drug American Dream World History: The 1st Report－ |
Kurihara C，Inoue T | 339-46 W47-W54 |
Full text | |
| Translation：PET drug clinical trials and networking strategy for development －PET Drug American Dream World History: The 2nd Report－ |
Kurihara C，Inoue T | 347-53 W55-W61 |
Full text | |
| Translation：Insurance coverage of PET drugs and imaging accreditation in the U.S. －PET Drug American Dream World History: The 3rd Report－ |
Kurihara C，Inoue T | 355-63 W63-W71 |
Full text | |