LEXICON

• Primary endpoint主要評価項目
  Secondary endpoint副次評価項目
  October 24, 2011

• Premiums for generics dispensing systems後発医薬品調剤体制加算
  Premiums for generics use systems後発医薬品使用体制加算
  October 17, 2011

• R&D tax credit system研究開発税制
  Preferential taxation system優遇税制
  Tax deduction; tax exemption税額控除
  October 10, 2011

• Hemoglobin A1c (HbA1c)ヘモグロビンA1c
  HbA1c determined by the NGSP (National Glycohemoglobin Standardization Program) methodNGSP値 (HbA1c (NGSP))
  HbA1c determined by the JDS (Japan Diabetes Society) methodJDS値 (HbA1c (JDS; 日本糖尿病学会))
  October 3, 2011

• GMP (Good Manufacturing Practice) (compliance) inspectionsGMP(適合性)調査
  GMP inspectorsGMP調査員
  Sampling (samples); collection of samples収去(品)
  September 26, 2011

• (New drug application (NDA)) Review report審査報告書
  Report on the deliberation results審議結果報告書
  Clinical trial (study) report治験総括報告書
  Summary technical documentation (STED)申請資料概要
  Application for marketing approval; new drug application (NDA)製造販売承認申請書
  Application dossier申請資料
  Summary basis of approval (SBA)新医薬品承認審査概要
  September 19, 2011

• Marketing authorization holder製造販売業者
  Manufacturing/manufacturer製造(元)
  Sales, distribution/distributor販売(元)
  Marketing/marketer (marketing authorization holder)発売(元)
  Promotion販促
  September 12, 2011

• Minimum statutory NHI drug price最低薬価
  September 5, 2011

• Bulk buying by sum value or bundling総価取引 or 総価山買い
  September 5, 2011

• No-fault compensation system無過失補償制度
  August 29, 2011

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