Vol.46, No.3・4, Feb. 2019
Clinical trial data sharing; Clinical Trial Act in Japan / FDA・EMA Guidance on botanical/herbal product development/
From the symposium titled “Product development and research ethics: the past, present and future”
at the 16th annual meeting of the Japanese Society for Science and Technology Studies
 
Contents
 
EditorialKurihara M434 Full text
 
Clinical trial data sharing; Clinical Trial Act in Japan /
 FDA・EMA Guidance on botanical/herbal product development
 Research infrastructure for individual participant data sharing in clinical trialsKono K435-52Abstract
 Meaning to translate “FDA Guidance for Industry: Botanical Drug Development”Nishimura H453-4
 Botanical Drug Development Guidance for IndustryU.S. Department of Health and Human Services,
Food and Drug Administration,
Center for Drug Evaluation and Research (CDER)
(Trans. by Nishimura H,Taketsuna M)
455-79
 Guideline on Good Agricultural and Collection Practice (GACP) for
  Starting Materials of Herbal Origin
European Medicines Agency,
Committee on Herbal Medicinal Products (HMPC)
(Trans. by Nishimura H)
481-8
 Efforts to align with the Clinical Trials Act at Osaka University HospitalAsano K,Iwasaki K,Kobayashi M,et al. 489-95Abstract
 
Article
 Chronic pains and psychiatric diseases of Ehlers-Danlos syndrome: A literature reviewSaio T 497-503Abstract
 
From the symposium titled
 “Product development and research ethics: the past, present and future”
 at the 16th annual meeting of the Japanese Society for Science and Technology Studies
 Dual use issues in a transitional period of life sciences and bioethicsKawahara N 505-12Abstract
 The end of the DSM era and the rise of pluralism in psychiatryKuroki T 513-24Abstract
 Manipulative business: Janus-faced modern enterprises and dual usage of psychological techniquesSaio T 525-34Abstract
 Product development and research ethics: the past, present and future
  -At the crossroad of the “dual use” of technology
Kurihara C,Saio T 535-48Abstract
 
Material
 Compensation for clinical trial related injury-Commentary for clinical trial of medical device-The Japan Federation of
Medical Devices Associations
549-68
 
Instructions for authors [Japanese] & [English]569-77Full text
 
Editor's noteKageyama S579Full text


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