Vol.39, No.2, Oct. 2011
Public Debriefing Session 2010 /
International symposium of early stage clinical trial in Beppu
   
Contents
 
EditorialFukushima M214-5
 
Public Debriefing Session 2010
 Clinical trials of academia original seeds that began to move

        Organized by:Foundation for Biomedical Research and Innovation
 217-324
 Annual Reports of Translational Research 2010Saruta T220
 Current status and networking of Translational Research Support OrganizationsNagai Y221-6
 Clinical trial of a novel artificial wrist joint (NM002)Inage F,Iwasaki N,Minami A227-32
 Evaluation of efficacy and safety of a new hip arthroplasty implant (AMU001)
   for patients with functional disturbance of the hip joint
Hayashi H,Ito H,Tanino H,et al.233-7
 Investigation of safety and pharmacokinetics of N-acetylneuraminic acid in patients
   with Distal myopathy with rimmed vaculoles (DMRV)
   – hereditary inclusion body myopathy (hIBM)
Asada R,Aoki M238-43
 Clinical trial of novel bioabsorbable pericardial substituteKikuchi K,Tabayashi K,Saiki Y244-8
 The translational research of fetal electrocardiogram
   with non-connected wide range electrodes
   and the establishment of its clinical applications
Kikuchi K,Kimura Y,Satou N,Ito T249-54
 Trials in chronic skin ulcers using new collagen substitutes
   incorporating basic fibroblast growth factor (TR11)
Shimizu A,Suzuki S255-60
 Leptin-replacement therapy on lipodystrophy (TR06)Shimizu A,Nakao K261-5
 Development of new strategy for severe heart failure using autologous myoblast sheetsSaito A,Miyagawa S,Yoshikawa Y,et al.266-71
 Cancer immunotherapy targeting Wilms’ tumor gene WT1 productEzaki H,Sugiyama H272-4
 An academia-sponsored Phase Ⅰ trial of BK-UM,
   a targeted-therapy drug candidate for ovarian cancer
Umegaki M,Miyamoto S,Mekata E275-80
 Clinical trial of the malaria vaccine for travellersOkada K,Horii T,Ishii K,Tetsutani K281-6
 Intramuscular transplantation of autologous peripheral blood CD34 cells into patients
   with critical limb ischemia
Wada J,Kawamoto A287-9
 Regenerative therapy for osteoarthritis by cultured autologous chondrocytesGo M,Kuroda R290-2
 Clinical trial of a novel RNA drug based on recombinant Sendai virus for the treatment
   of peripheral arterial disease
Uchiyama M,Yonemitsu Y,Matsumoto T,et al.293-9
 The development of vascular endothelial cell selective nanotechnology based drug delivery system
   for less invasive nanotherapy
Nakano K,Egashira K300-4
 Development of a novel therapy for malignant mesothelioma by humanized anti-CD26 antibodyMorimoto C,Hosono O305-8
 Clinical development of oncolytic virus therapyTodo T309-14
 Coordination, Support and Training Program for Translational Research –
   Another awareness gap regarding funding
Koga T315-6
 Summation and direction to the next step – Network management for innovationFukushima M317-22
 
International symposium of early stage clinical trial in Beppu
 Why do we focus on early stage clinical trials now?

  Organized by:Clinical Pharmacology Center, Oita University Hospital
  The Head of the Executive Committee:Ohashi K
 325-84
 Why do we focus on early stage clinical trials now?Ohashi K327-30
 PET and microdose study for early clinical trials in JapanMorimoto T331-5
 Biomarkers and surrogate endpoints in clinical trialsWatanabe H336-9
 Regulatory view point for a use of biomarkers in drug developmentUyama Y340-4
 Exploratory clinical trials in early drug developmentUemura N345-8
 How to manage to include Japan in global clinical studiesKunitada S349-56
 Experience of early clinical trials in Oita University HospitalSuzaki Y357-61
 Experience in a multi-center Phase Ⅰ study in Japanese patientsUchida E362-6
 The current status and policy of early stage clinical trials in KoreaShin SG367-75
 Japanese policy for innovative drug developmentMiyata T376-81
 Plenary discussion 382-4
 
Interview  
 The nursing scientist as a principal investigator (PI) of clinical trials on dementia
   –Interview with Associate Professor Ruth A. Mulnard –
  ・Full text version in English is here !
Mulnard RA
(Interview and trans. by Kurihara C,Saio T)
385-94
 
Articles  
 Current status in the regulation of research that involves human subjects in South Korea and ChinaMotojima M,Ichikawa I395-406
 Factors associated with the continued participation of physicians in the study extension;
   From the experience of the CASE-J Extension
Kobayashi J,Ueshima K,Oe Y,et al.407-12
 
Forum  
 New strategies for drug development using the exploratory early clinical trials approachYano T413-9
 
Instructions for authors [Japanese] & [English] 421-9
 
Editor's noteHirotsu C431


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