…Of these, the double-blind trial is currently considered the most scientifically resistant. In a double-blind trial, the participating patients are stratified and randomly selected into two groups, and one group is given the test drug (the real drug) and the other group is given a completely ineffective placebo or the standard treatment activep lacebo according to an allocation table kept by the controller. The double-blind method was named because neither the patients nor the doctors in charge know who is receiving the real drug. Currently, the documents required for the manufacturing approval of pharmaceuticals are clinical cases from more than five sites, more than 150 cases, and more than 20 cases per site for each major efficacy. … *Some of the terminology explanations that mention "active placebo" are listed below. Source | Heibonsha World Encyclopedia 2nd Edition | Information |
…これらのうち,現在は二重盲検試験が最も科学的評価に耐えうる試験とされている。 二重盲検試験とは,参加した患者を,層別化し,無作為抽出によって2群に分け,コントローラーが保持した割付表に従って,一群には試験薬(真薬)を,他の群にはまったく有効性をもたない偽薬placeboあるいは標準治療薬activep laceboを与える方法で,患者も管理する医師も,だれに真薬が投与されているかわからない,ということから二重盲検法と命名された。現在,医薬品の製造承認書に必要な資料として,5ヵ所以上,150例以上,1主要効能あたり,1ヵ所20例以上の臨床例が必要とされている。… ※「active placebo」について言及している用語解説の一部を掲載しています。 出典|株式会社平凡社世界大百科事典 第2版について | 情報 |
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