国際共同治験の現状と海外データの評価 - Pmda
2012 9 Pharmaceuticals & Medical Devices Agency (PMDA) 2012 9 Pharmaceuticals & Medical Devices Agency versionEnglish version 2 2012 9 Pharmaceuticals & Medical Devices Agency 3 ICH E5 2012 9 Pharmaceuticals & Medical Devices AgencyTrends of GCTs including Japan40 5 10 15 20 25 30 0 50 100 150 200 250 300 350 400 % of MRCTsNumbers of All CTNFY2007(Apr-Sep)FY2008(Oct-Mar)FY2009F Y2010FY2011(Apr-Sep)(Oct-Mar)(Apr-Sep)(O ct-Mar)(Apr-Sep)(Oct-Mar)(Apr-Sep)(Oct-M ar) 2012 9 Pharmaceuticals & Medical Devices AgencyGCTs or Bridging-based Drug Approval5FY2007FY2008FY2009FY2010FY20110 255075100125 Total Bridging GCTNumber of Approved DrugsYear0246810 % of GCT % of Bridging% 2012 9 Pharmaceuticals & Medical Devices AgencyGCT-based Drug Approval (1)6Name of DrugIndicationApprovalTolterodineOveract ive bladder with symptoms of urge urinary incontinence, urgency, and frequencyApr.
Chronic myeloid leukemia (CML) Jun. 2011. Indacaterol: Chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Jul. 2011: Linagliptin. Type 2 diabetes mellitus (adjunctive to diet and exercise) Jul. 2011
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