●Editorial | Tsubaki H | 260 |
●Review | ||
Statistical principles for clinical evaluation | Tsubaki H | 261-8 |
●The use of Bayesian statistics in clinical trials | ||
Introduction to Bayesian statistics | Matsuyama Y | 269-79 |
Applications of Bayesian statistics to early phase cancer clinical trials | Morita S | 281-90 |
Guidance for Industry and FDA Staff Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH),et al. |
(trans. by Teramukai S,Daimon T) | 291-326 |
On the FDA guidance for the use of Bayesian statistics in medical device clinical trials | Teramukai S,Daimon T | 327-34 |
●Interview | ||
Interview with Prof. David Yang PET molecular imaging, drug development, and FDA guidance | Yang D (Interview and supervising trans. by Inoue T,Kurihara C) | 335-52 |
Commentary on the interview with Prof. David Yang PET molecular imaging in the RDRC system and drug development in United States | Kurihara C,Inoue T | 353-8 |
●Lecture | ||
Lecture by Dr. Cate Howell Keeping the blues away: The ten-step guide to reducing the relapse of depression | Howell C | 359-73 |
Relapse-recurrence prevention of depressive disorders: Review of the literature with an impression on the lecture of Dr. Cate Howell in Tokyo 2010 | Saio T | 375-8 |
●Articles | ||
Unveiling Japanese pricing of biosimilar drugs: To clarify muddied regulatory rules of pricing | Kamada I,Yokoya S | 379-84 |
On extrapolation of animal experimentations to humans: An overview | Saio T,Kurihara C | 385-92 |
●Translation and article | ||
Toward More Uniform Conflict Disclosures: The Updated ICMJE Conflict of Interest Reporting Form |
Drazen JM,de Leeuw PW,Laine C,et al. (trans. by Saio T,Fukushima Y) |
393-403 |
Commentary on the revision of “Uniform Disclosure Form for Potential Conflicts of Interest” by ICMJE | Kurihara C,Saio T | 405-9 |
●Instructions for authors [Japanese] & [English] | 411-6 | |
●Editor's note | Tsuchiya F | 417 |