Vol.47, No.1, Jun. 2019
Product development and innovation in the era of Digital Health /
Academia-initiated product development and the Clinical Trials Act
EditorialKurihara C4-5Full text
Product development and innovation in the era of Digital Health
 Round table discussion:Digital Health and longevity:
  Current status and prospects of innovation through
   the utilization of big data and medical-engineering collaboration
Ishii T,Takaku F,Kurihara M
(Organized by Kurihara C,
 Cooperated by Fukunaga A, Nakayama R)
7-25Full text
 The application of artificial intelligence (AI) to drug discovery and
  development from the perspective towards “Precision Medicine”:
   A view from an integrative basis with statistics, genetics,
    and informatics-Interview with Dr. Naoyuki Kamatani-
Kamatani N
(Interviewed by Kurihara C,Saio T)
 Transforming clinical trials with Digital Health technology
  in the pharmaceutical industry
Sugiura K49-58Abstract
 Convergence of the pharmaceutical and non-pharmaceutical industries
  -The era without borders-
Masui K 59-68Abstract
 The future of the pharmaceutical industry in utilizing Real-World Data
  and Digital Health: Current progress in the field of pharmacovigilance
Aoki K 69-76Abstract
 Future perspective of the pharmaceutical industry utilizing
  Real World Data and Digital Health:“What do we need
   to understand and prepare for this transformation ?”
Nabeoka Y,Niikawa Y,
Suzuki C,et al.
77-86Full text
Academia-initiated product development and the Clinical Trials Act
 Current FDA or EMA approval status of biopharmaceuticals
  developed in Japan: focus on hormones, cytokines, and enzymes
Morimoto K,Kobayashi T,
Shibata H,Ishii-Watabe A
87-97Full text
 Availability of the outcomes of clinical studies conducted under
  the Clinical Trials Act for pharmaceutical application
Araki Y,Sugita H,
Sasaki T
 Considering the future of clinical research at the turning point
  of implementation of the new legislation in Japan
   -Impact of the Clinical Trials Act on Pharmaceutical Industries;
    Based on the results from the internal survey in JPMA-
Ohshima H,Aoyagi M,
Tajima M,et al.
115-25Full text
 A proposal to improve the implementation of the Clinical Trials Act,
  based on the comparison of the three research regulations in Japan
   -Report 1: the quality and safety assurance
    of investigational medicinal products-
Kurihara C,Suzuki C,
Koike R,et al.
127-52Full text
 Is a no-suicide contract valid ?Saio T,Kurihara M 153-62Full text
 Use of Real-World Evidence to Support Regulatory
  Decision-Making for Medical Devices
   Guidance for Industry and Food and Drug Administration Staff
U.S. Department of Health and Human Services
Food and Drug Administration,
Center for Devices and Radiological Health (CDRH);
Center for Biologics Evaluation and Research (CBER)
(Trans. by Kurihara C,Saio T)
163-83Full text
 Chapter 6 Ethics, Regulations, and Clinical Development
  of Precision Medicine: Activating with Molecular Imaging
Kurihara C,Inoue T
(Trans. by Kurihara C)
Instructions for authors[Japanese]&[English] 361-9Full text
Editor's noteKurihara M 215Full text

Back to Rinsho Hyoka(Clinical Evaluation) home page
Back to Contents