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論文（共薬ジャーナル） - 慶應義塾大学 薬学部・薬学研究科
ේ⪺⺰ᢥ ᴦ㛎ࠦ࠺ࠖࡀ࠲߆ࠄߚᣣᧄߣࠝࠬ࠻ࠕߦ߅ߌࠆ ⮎‛⥃ᐥ⹜㛎ߩታᣉ⁁ᴫߩᲧセ 㧙⨶ේ∛㒮ߣ Q-Pharm ࠍਛᔃߦ㧙 A CRC’s View on Conduct of Clinical Drug Study in Australia and Japan 㧙 A Comparison between Ebara Hospital and Q-Pharm 㧙 ዊᨋ ᢥ 1,2㧘ጊፒᕡ⟵ 1㧘⺪⸰ବ↵ 1 Aya Kobayashi1,2, Tsuneyoshi Yamazaki1, Toshio Suwa1 1 ┙⮎⑼ᄢቇ⥃ᐥ⮎‛⹏ଔቇ⻠ᐳޔ2 ⽷࿅ᴺੱ᧲੩ㇺஜක≮␠⨶ේ∛㒮 1 Department of Drug Development Science and Clinical Evaluation, Kyoritsu University of Pharmacy 2 Clinical Research Center, Tokyo Metropolitan Health and Medical Treatment Ebara Hospital (Received August 1, 2007; Revised September 20, 2007, Accepted September 27, 2007) A comparison was made on the conduct of clinical trial at the Tokyo Metropolitan Health and Medical Treatment Ebara Hospital in Japan and Q-Pharm Pty Limited in Australia. The followings were pointed out as the differences of role and responsibility between CRC of Ebara Hospital and SC of Q-Pharm.. 1) The SC of Q-Pharm is actively involved in managing clinical study itself, such as organizing study team members. The attitude of CRCs of Ebara Hospital is inclined to assist investigator rather than manage. The CRCs also make considerable effort in coordinating functions in the hospital and are involved in the study. 2) The coverage of CRC at Ebara Hospital is wider than that of SC of Q-Pharm. The tasks of CRC extend from contacting to sponsor before the contract is signed, complementary explanation of the study to recruited study subjects, participation to study audit. The main tasks of SC start from initiation of a study. The SC does not get involved in obtaining the informed consent from study subjects. 3) The role and responsibility of SC of Q-Pharm is described in the job description, whereas, no job description is available for CRC of Ebara Hospital. 4) It is presumed that the clarification of the job of CRC in Japanese study sites will lead to the improvement of efficiency of clinical study conduct. ✜⸒ ㅢߥ᳓Ḱࠍ⛽ᜬߒߡታᣉߐࠇࠆߎߣߣߥߞߚޕ ICH-GCP એ㒠ޔ⇇⊛ߦߪ⮎‛ߩ⥃ᐥ⹏ଔ⹜㛎 ⦟ࠅࠃޟක⮎ຠࠍࠃࠅᣧߊᖚ⠪ߩర߳㧍ߣޠ ߪᄙ࿖㑆ᄙᣉ⸳ߦࠃࠆ⹜㛎࡞ࡃࡠࠣࠆࠁࠊޔ ߁⇇ㅢߩ㗿ࠍ㆐ᚑߐߖࠆߚߦ ICH ߇ࠬ ᴦ㛎߇Ⴧടߔࠆะߦࠆ৻ߩߘߒ߆ߒޕᣇޔᣣᧄ ࠲࠻ߒߡ߆ࠄᣢߦ 15 ᐕએ߇⚻ㆊߒߚ߇ࠊޕ࿖ ߩᴦ㛎ߪޠ࠻ࠬࠦޟ ޔ ᤨޟ㑆ޔޠ ߩޠ⾰ޟ㕙ߢߩ㗴ࠍ ߦ߅ߡߪ 1997 ᐕߦ ICH-GCP ߦၮߠߚޟක⮎ຠ ᜰ៰ߐࠇ࡞ࡃࡠࠣ߆ߥ߆ߥޔᴦ㛎ߩખ㑆ࠅ߇ߢ ߩ⥃ᐥ⹜㛎ߩታᣉၮḰ㧔ࠊࠁࠆ J-GCP㧕߇ޠᴺ ߈ߦߊߩ߇⁁ߢࠆޕ ൻߐࠇޔએᓟߩᣂ⮎ߩ⥃ᐥ⹏ଔ㧔ᴦ㛎㧕ߪ⇇⊛ߦ 1/12 ╩⠪㧔ዊᨋޔએᓟ╩⠪㧕ߪޔ⽷ޔ࿅ᴺੱ᧲੩ J Kyoritsu Univ Pharm 2007. 10 Vol. 3 39 Kobayashi A et al. ㇺஜක≮␠⨶ේ∛㒮㧔એᓟޔ ⨶ޟේ∛㒮ޠ㧕ߢᴦ CRC ߩታോࠍਛᔃߦ⺞ᩏߒߚⷰߡߒߘޕኤ⺞ᩏ 㛎ࠦ࠺ࠖࡀ࠲㧔એᓟޟCRCޠ㧕ᬺോߦᓥߒ ߩ⚿ᨐࠍ⨶ේ∛㒮ߦ߅ߌࠆᴦ㛎ታᣉ⁁ᴫߣᲧセߒ ߡࠆ⮎Ꮷߢࠆޕᴦ㛎ᬺോߦ៤ࠊࠆ CRC ߪో ߚ࠼ࡦ࠭ࡦࠗࠢޕᄢቇ߳ߩṛᦼ㑆ߪᐔᚑ 19 ຬ GCP ߩ♖ߣታോࠍࠃߊℂ⸃ߒߟߟᣂ⮎ߩ⥃ᐥ ᐕ 1 ߆ࠄ 3 ߹ߢߩ 3 ࡩ㑆ߢߞߚޔߦᦝޕṛ ⹜㛎㧔ᴦ㛎㧕ߦขࠅ⚵ߺߩ⾰ޔ㜞⥃ᐥ࠺࠲ࠍ ⚳ੌᓟߦਇ⿷ߔࠆᖱႎࠍ Q-Pharm ߆ࠄㅊടᚻ 㓸ߔߴߊᣣޘദജߒߡࠆޔߕࠄࠊ߆߆߽ߦޕᣣᧄ ߒߚޕ૬ߖߡޔᢥ₂ᬌ⚝ߦࠃࠅࠝࠬ࠻ࠕߩ ߩᴦ㛎ߪᶏᄖ߆ࠄߩᛕ್ࠍฃߌޔ࿖㓙ᴦ㛎ߦෳടߒ CRC ߩᢎ⢒߿ታോ⁁ᴫߦ㑐ߔࠆᖱႎࠍᚻߒߚޕ ߦߊߣ߁⁁ߦ㆑ᗵࠍᜬߞߡࠆޟޕᣣ ᧄߩᴦ㛎߇ᶏᄖ߆ࠄߘߩࠃ߁ߦૐ⹏ଔࠍฃߌࠆ ߩߛࠈ߁㧫⇼߁ߣޠߣหᤨߦߪߢࠇߘޟޔᶏᄖ ⚿ᨐ ߩᴦ㛎ߣᣣᧄߩᴦ㛎ߢߪ⠨߃ᣇ߿ታᣉ㕙ߢ৻ߤ ߩࠃ߁ߥ㆑߇ࠆߩߛࠈ߁߆㧫╩ߦߣߎ߁ߣޠ 1㧚ࠝࠬ࠻ࠕߩ⥃ᐥ⎇ⓥⅣႺߣ Q-Pharm ⠪ߪ⥝߽ᜬߟࠃ߁ߦߥߞߚ⑼⮎┙ߡߒߘޕᄢቇ ߩ┙⸳⁁ᴫ ߦ␠ળੱᄢቇ㒮↢ߣߒߡቇߒޔ࿁ޔ࿖㓙ᴦ㛎ߩ ࠝࠬ࠻ࠕߪੱญ⚂ 2000 ਁੱߩ࿖ߢࠆޕ ⚻㛎⼾߆ߥࠝࠬ࠻ࠕߩࡉࠬࡌࡦᏒߦ ߆ߟߡߪ⧷࿖ߩ⛔ᴦਅߦߞߚߚක≮ࠍᄙ ࠆࠢࠗࡦ࠭ࡦ࠼ᄢቇ㑐ㅪߩ⥃ᐥ⹜㛎ฃ⸤ᣉ⸳ ߊߩಽ㊁ߢ⧷࿖ߩᢥൻ߿ᘠ⠌ߩᓇ㗀ࠍᒝߊฃߌߡ Q-Pharm Pty Limited㧔એᓟޟQ-Pharmޠ㧕ߢ⮎‛⥃ᐥ ࠆޕߩਥⷐߥ↥ᬺߪ㋶ᬺߣㄘᬺߢࠆ߇ޔㄭ ⎇ⓥߩታോࠍⷰኤ⺞ᩏߔࠆᯏળࠍᓧߚޕ ᐕߎߩ࿖ߩ↥ᬺߩ 3 ⇟⋡ߩᩇߦߔߴߊࡃࠗࠝࠨࠗ ᧄⷰኤ⺞ᩏߩ⋡⊛ߪᰴߩ 3 ὐߢࠆޕ ࠛࡦࠬߦജࠍࠇߡࠆޕ࿖ౝߦഃ⮎߇น⢻ߥⷙᮨ Ԙ ࠝࠬ࠻ࠕߦ߅ߌࠆ⮎‛ߩ⥃ᐥ⹏ଔ⹜㛎 ߩ⮎ડᬺߪᧂߛሽߖߕޔᄙߊߩᣂ⮎ߪ᰷ߩᄢ ⮎ડᬺ߆ࠄଏ⛎ߐࠇߡࠆ৻ޕᣇࠛࠗࠨࠝࠗࡃޔ ߩታോࠍ⚻㛎ߔࠆߎߣ ԙ ᣣᧄߣࠝࠬ࠻ࠕߩ⥃ᐥ⹜㛎ߦ߅ߌࠆ ࡦࠬߩಽ㊁ߦߪᄢቇ⊒ߩࡌࡦ࠴ࡖડᬺߪᢙᄙߊ ሽߔࠆޕ CRC ߩᓎഀߣታോౝኈࠍᲧセߔࠆߎߣ Ԛ Ყセᬌ⸛ߩ⚿ᨐߦၮߠ߈ CRC ߩⷰὐ߆ࠄᣣᧄ ࠢࠗࡦ࠭ࡦ࠼ᄢቇߪࠝࠬ࠻ࠕߩ᧲ർ ߩᴦ㛎ߩല₸ൻߣࠣࡠࡃ࡞ᴦ㛎߳ߩෳߩ ㇱߦ⟎ߔࠆࠢࠗࡦ࠭ࡦ࠼ᎺߩᎺㇺࡉࠬ ᚻ┙ߡࠍᮨ⚝ߔࠆߎߣ ࡌࡦ㧔ੱญ⚂ 150 ਁੱ㧕ߦࠆቇ↢ᢙ⚂ 3 ਁ 5 ජ ੱߩᎺ┙✚วᄢቇߢࠆࡉߪࠬࡄࡦࡖࠠࡦࠗࡔޕ ࠬࡌࡦᏒߩ࠳࠙ࡦ࠲࠙ࡦ߆ࠄ߿߿ౝ㒽ߦ⟎ ᣇᴺ ߔࠆࡦ࠻࡞ࠪࠕ㧔St.Lucia㧕ߦࠆ߇ޔකቇㇱ ߩ৻ㇱߣ㑐ㅪ∛㒮ᣉ⸳ߪ࠳࠙ࡦ࠲࠙ࡦ߆ࠄࡃࠬߢ ┙⮎⑼ᄢቇߪᢥㇱ⑼ቇ⋭߇㓸ߒߚᄢቇᢎ⢒ 20 ಽ߶ߤߩᏒౝߦࠅࡦࡌࠬࡉ࡞ࡗࠗࡠޔ ᡷ㕟ᬺޟ㝯ജࠆᄢቇᢎ⢒㧔ࠊࠁࠆᄢቇ㒮 GP㧕 ޠ ߮↥⑼∛㒮⟲㧔The Royal Brisbane and 㨃omen’s ࠗ࠾ࠪࠕ࠴ࡉߦᔕߒޟޔ࿖㓙ᕈߣ⎇ⓥ⢻ജࠍ߃ Hospitalsޔએᓟ RBH ∛㒮⟲㧕ߣ߫ࠇࠆᄢ߈ߥ∛ ߚ⥃ᐥ⮎Ꮷߩ⢒ᚑ㧔ᐔᚑ 18~19 ᐕᐲ㧕ࠣࡠࡊޠ 㒮ᣉ⸳⟲ࠍᒻᚑߒߡࠆ∛ߩߎޕ㒮⟲ߩਛᩭߢࠆ ࡓ߇ណᛯߐࠇߚ╩ޕ⠪ߪߎߩᄢቇ㒮 GP ߩᡰេࠍฃ ࡠࠗࡗ࡞ࡉࠬࡌࡦ߮↥⑼∛㒮ߪࡌ࠶࠼ᢙ ߌߡࠢࠗࡦ࠭ࡦ࠼ᄢቇකቇㇱ⮎‛ઍ⻢⎇ⓥᚲ 948 ᐥࠍᜬߟ߇ޔ㓞ធߔࠆࡠࠗࡗ࡞ዊఽ∛㒮㧔The 㧔 Center for Studies in Drug Disposition ޔએ ਅ Royal Children Hospital࠼࠶ࡌޔᢙ 160㧕߽ߩ⁛┙ ޟCSDDޠ㧕ߦ☋ࠍ⟎߈ޔᄢቇߦ㑐ㅪߒޔ㓞ធߔࠆ ߒߚ∛㒮ߣߒߡㆇ༡ߐࠇߡࠆ╩ޔߚ߹ޕ⠪߇☋ࠍ ⥃ᐥ⹜㛎ฃ⸤ᯏ㑐 Q-Pharm ߢ⥃ᐥ⹜㛎ߩታᣉ⁁ᴫ ߅ߚࠢࠗࡦ࠭ࡦ࠼ᄢቇකቇㇱ CSDD ߅ࠃ߮ ࠍ⺞ᩏߒߚ⺞ޕᩏߪ⹜㛎ᣉ⸳ߩⷐ⹜ޔ㛎ታᣉߩ⁁ Q-Pharm ߽ߎߩ∛㒮⟲ౝߦࠆޕ ᴫ⹜ޔ㛎ታᣉߩߚߩ⻉ᢥᦠߥߤߦࠎߛ߇ߦ․ޔ 40 J Kyoritsu Univ Pharm 2007. 10 Vol. 3 2/12 ╩⠪߇ታോ⺞ᩏࠍⴕߞߚ Q-Pharm ߪ RBH ∛㒮⟲ 原著論文 ౮⌀ 3 Q㧙Pharm ࠬ࠲࠶ࡈߣ╩⠪ ౮⌀ 1 Q㧙Pharm㧔1.6 㓏㧕 ౮⌀ 4 ᴦ㛎࡞ࡓ ࠕࠞࠗࡉߥߤߢࠆ߽ࠇߕޕචಽߥࡈࡠࠕ㕙Ⓧ ࠍ߽ߜߚߒߣࠅߚߞࠁޔ㔓࿐᳇߇ࠆޕ ஜᏱⵍ㛎⠪ኻ⽎ߩࠢ࠾࠶ࠢߪਛᄩߦ⹜㛎࠴ ࡓ↪ߩࡉࠬ߇⟎߆ࠇⵍޔ㛎⠪↪ߩࡌ࠶࠼ߪߘߩ ౮⌀ 2 ࡉࠬࡌࡦߩⴝਗߺ ࡉࠬࠍ࿐ࠃ߁ߦࠦߩሼဳߦ㈩⟎ߐࠇߡࠆޕㇱ ደߩోߡߩᩇߦᄢ߈ߥᤨ⸘߇߆ߌࠄࠇߡ߅ࠅߩߤޔ ౝߦࠆࡏ࠻ߣࠢ࠾࠶ࠢࠍ૬ߖᜬߟ⥃ ⵍ㛎⠪߽ኈᤃߦ⥄ಽߢࠬࠤࠫࡘ࡞▤ℂ߇ߢ߈ࠆ ᐥ⮎ℂ⹜㛎ฃ⸤ળ␠ߢࠆޕฃ⸤น⢻ߥ⹜㛎ߪ╙Σ ࠃ߁㈩ᘦߐࠇߡࠆⵍޔߚ߹ޕ㛎⠪߇࠶ࠢࠬߢ ⋧⥃ᐥ⹜㛎‛↢ޔቇ⊛ห╬ᕈ⹜㛎․ޔ߮ࠃ߅ޔቯߩ ߈ࠆࠃ߁ߦ⹜㛎ቶߩ৻ⷺߦߪ࠰ࡈࠔࠍ߃ߚભ ∔ᖚᖚ⠪ߦࠃࠆ⥃ᐥ⮎ℂ⹜㛎ߢࠆ߇ޔታᣉߒߡ ᕷቶ߇ࠅ࠹ࡆ߿ᦠ‛߇߅߆ࠇߡࠆޕ ࠆᄙߊߩ⹜㛎ߪ↢‛ቇ⊛ห╬ᕈ⹜㛎ߢࠆޕ Q-Pharm ߦߪ✚ 100 ฬࠍ߃ࠆࠬ࠲࠶ࡈ߇ൕോ ࠝࠬ࠻ࠕߪ↥ᬺᝄ⥝ߦᾲᔃߢࠅޔ╷⊛ ߒߡߚޕ㓹↪ᒻᘒߪᱜ␠ຬޔ㕖Ᏹൕ␠ຬⷐᤨ⥃ޔ ߦᄢቇ⊒ࡌࡦ࠴ࡖડᬺߩ⢒ᚑࠍ࿑ߞߡࠆ߇ޔ ຬߩ 3 ⒳ߦಽ߆ࠇߡߚ࡞ࠞࠖ࠺ࡔߪߦ⊛❱⚵ޕㇱ Q-Pharm ߽ࠢࠗࡦ࠭ࡦ࠼ᄢቇකቇㇱ CSDD ߆ 㐷ࠢ࠶࠾ࠢޔㇱ㐷ޔಽᨆㇱ㐷✚ޔോㇱ㐷 ࠄࠬࡇࡦࠕ࠙࠻ߒߚࡌࡦ࠴ࡖડᬺߩ㧝ߟߢࠆޕ 㧔Administration㧕ޔ߮ຠ⾰⸽ㇱ㐷ߦಽ߆ࠇߡ߅ CSDD ߢߪએ೨߆ࠄડᬺ߆ࠄฃ⸤ߒߡ⮎‛േᘒ⹜ ࠅ࡞ࠞࠖ࠺ࡔޔㇱ㐷ߪ⹜㛎⽿છකᏧ 4 ฬ㧔ߕࠇ߽ 㛎߿⥃ᐥ⮎ℂ⹜㛎ࠍታᣉߒߡ߈ߚ߇ޔ2002 ᐕߦฃ 㕖Ᏹൕ㧕ߣ⮎Ꮷ 2 ฬ㧔1 ฬߪᱜ␠ຬ ઁޔ1 ฬߪ㕖 ⸤⹜㛎ߩㇱಽࠍಾࠅ㔌ߒޔቇౝߦ Q-Pharm ࠍ⸳┙ Ᏹൕߩઍⷐຬ㧕ߢ᭴ᚑߐࠇߡߚޕᣣᧄߩ CRC ߒߚޕQ-Pharm ߪ㧝ߟߩ∛㒮ࡆ࡞ߩ 2 ࡈࡠࠕࠍභ ߦ⋧ᒰߔࠆࠬ࠲࠺ࠖࠦ࠺ࠖࡀ࠲㧔study ߡ߅ࠅ✚ߩߘޔᐥ㕙Ⓧߪ⚂ 3,000 ᐔᣇࡔ࠻࡞ߢ coordinatorޔએᓟޟSCޠ㧕ߪࠢ࠾࠶ࠢㇱ㐷ߦᚲዻ ߞߚޕਥⷐߥ⸳ߪஜᏱⵍ㛎⠪ኻ⽎ߩ 36 ࡌ࠶࠼ ߒߩߘޔᢙߪ 15 ฬߩߎޕㇱ㐷ߦߪઁߦࡑࡀࠫࡖ5 ߩᄢ߈ߥ⥃ᐥ⹜㛎ቶ⥃ޔᐥ⮎ℂ⎇ⓥ↪ߦฦ⒳ߩ᷹ቯ ฬ࠻࡞ࠢޔᜂᒰ 5 ฬ ࠻ࡦࡔࠫࡀࡑ࠲࠺ޔ5 ࡕ࠾࠲ᯏེࠍ߃ߚቶޔಽᨆࡏ⺞ޔࡏޔ ฬ߅ࠃ߮⚂ 50 ฬߩ⥃ᤨⷐຬ߇ᚲዻߒߡ߅ࠅ⹜ޔ㛎 3/12 J Kyoritsu Univ Pharm 2007. 10 Vol. 3 41 Kobayashi A et al. ߩታᣉ߇ਥോߢߞߚޕಽᨆࡏߩⷐຬߪࡑࡀ ߿ GCP ࠍක⮎ຠߩ⎇ⓥ㐿⊒ߦ㑐ߔࠆᢎ⢒߇ ࠫࡖ2 ฬߣᛛⴚ⠪ 13 ฬߢߞߚࠖ࠺ࡔޔߚ߹ޕ ߹ࠇߡࠆ߇࠼ࡦ࠭ࡦࠗࠢޔᄢቇ⮎ቇㇱߩᢎ⢒ ࠞ࡞ࠗ࠲2 ฬߪ✚ോㇱ㐷ߦᚲዻߒޔຠ⾰⸽ㇱ ࠞࠠࡘࡓߪ᰷☨⻉࿖ߣห᭽ߦ⮎Ꮷ㙃ᚑࠍਛ 㐷ߪࡑࡀࠫࡖ1 ฬߣࠕࠪࠬ࠲ࡦ࠻ 1 ฬߢߞߚޕ ᔃߣߒߚᢎ⢒ߢࠅޔක⮎ຠ㐿⊒߿ᣂ⮎ߩ⥃ᐥ⎇ⓥ ␠㐳ߩ Professor Wayne Hooper ߪࠢࠗࡦ࠭ࡦ ߪᱴߤ߹ࠇߥߩߎߪߣߎߩߎޕ࿖ߢ⮎ቇりߩ ࠼ᄢቇᢎߩ⢋ᦠ߈߽ᜬߟޕએ೨ߪหᄢቇකቇㇱ CRC ߇⊝ήߦ╬ߒߎߣߩ㧝ߟߩℂ↱ߢࠆߣᕁ CSDD ߦᚲዻߒߚ⎇ⓥ⠪ߢߞߚߩࡦࠗ࠻࠾ࠚࡈޕ ࠊࠇࠆ⮎ߪߢࡦࡌࠬࡉޕቇ↢߿⮎Ꮷ߆ࠄ SC ᶖൻ▤ๆ߇ߩᷝട‛ࠍ♧߆ࠄ⎫㉄ࠞ࡞ࠪ ࠍ߿ࠅߚߣ߁Ꮧᦸߪ⡞߆ࠇߥޕ ࠙ࡓߦᄌ߃ࠆߎߣߦࠃࠅ⪺ߒߊᷫዋߔࠆߣ߁ᓐ ╩⠪߇ൕࠆ⨶ේ∛㒮ߩ CRC ߣ Q-Pharm ߩ SC ߩ⊒ߪ↢‛⮎ቇߩಽ㊁ߢߪࠃߊ⍮ࠄࠇߚᬺ❣ ߩ․ᕈࠍ㧝ߦᲧセߒߡ␜ߒߚޕCRC ᢎ⢒ߦ㑐ߒ 1㧕 ߡߪᣣᧄ⮎ߦࠕ࠻ࠬࠝޔᏧ߿⋴⼔Ꮷᢎ⢒ ߢࠆ ޕ ߩਛߦขࠅࠇࠄࠇߡߪߥޕਔ࿖ߣ߽ CRC ߣ 2. ࠬ࠲࠺ࠖࠦ࠺ࠖࡀ࠲㧔SC㧕ߣߘߩ ߒߡߩኾ㐷ᢎ⢒ࠍතᓟߦฃߌߡࠆޕCRC ᢎ⢒ߩ ᬺോ ႐ߣߒߡᣣᧄߢߪᣣᧄ⮎Ꮷ⎇ୃࡦ࠲ޔᣣᧄ⥃ ᣣᧄߢߪࠢ࠾ࠞ࡞ࠨ࠴ࠦ࠺ࠖࡀ ᐥ⮎ℂቇળޔᣣᧄ∛㒮⮎ᏧળޔSoCRAޔᣣᧄ⋴ ࠲㧔CRC㧕ߣ߫ࠇࠆ⡯⒳ࠍ Q-Pharm ߢߪࠬ࠲ ⼔දળޔᣣᧄකᏧળߥߤ߇⎇ୃࠦࠬࠍ⸳ߌߡ߅ ࠺ࠖࠦ࠺ࠖࡀ࠲㧔SC㧕ߣࠎߢߚޕ ࠅޔฃ⻠⚳ੌ⠪ߦߪቯ⸽ࠍ⊒ⴕߒߡࠆ߹ޕ ࿃ߺߦޟޔCRCߡߟߦޠߨߡߺߚ߇߁߁ߘޔ ߚޔਥⷐߥ SMO ߪ⥄␠ౝߦ CRC ᢎ⢒ࠦࠬࠍ⸳ ⒓ߪ⍮ࠄߥߣ߁߇ߞߡ߈ߚޕ ߌߡࠆߢࡦࡌࠬࡉޕᓧߚᖱႎߦࠃࠇ߫☨ޔ࿖ Q-Pharm ߩ SC ߪోຬ⋴⼔Ꮷߢࠆޕᣣᧄߩ CRC ߣ᰷Ꮊߦᧄࠍ⟎ߊ Association of Clinical Research ߪ⋴⼔Ꮷ⮎ޔᏧ⥃ޔᐥᬌᩏᛛᏧߩߕࠇ߆ߩ⾗ᩰ Professionals㧔ACRP㧕ߦࠃࠆ CRC ⎇ୃࠦࠬ߇㐿 ⠪ߢࠆߩߣߪᄢ߈ߥ㆑ߢࠆޕQ-Pharm ߩ SC ⻠ߐࠇߡ߅ࠅࠍࠬࠦߩߎޔฃߌߡߩߜ SC ᬺോߦ ߦ⮎ޟᏧߩ⾗ᩰࠍᜬߟ SC ߪߥߩ߆㧫ߣޠ ᓥߔࠆ⠪߇ࠆޕ 2 ߦ Q-Pharm ߩ SC ߩ⡯ോ⸥ㅀᦠࠍ␜ߒߚ⨶ޕ ߨߚߣߎࠈޔ ㅒߦޔ ޟ⮎Ꮷ߇ SC ࠍ߿ࠆߩ߆㧫ޠ ߣ߁⾰߇ߞߡ߈ߚ⮎ߢࠕ࠻ࠬࠝޕᏧ ේ∛㒮ߦߪ CRC ߦኻߔࠆߎߩࠃ߁ߥ⡯ോ⸥ㅀᦠߪ ߇ SC ᬺോߦዞ߆ߥߎߣߩℂ↱ߪߊߟ߆ࠆߛ ߥޕ⡯ോ⸥ㅀᦠߩౝኈߪ SC ߩޟPosition Purposeޠ ࠈ߁ޕᣣᧄߩ⮎♽ᄢቇߩᢎ⢒ࠞࠠࡘࡓߦߪᴦ㛎 ߣޟMajor Responsibility Areas ߩߣޠ2 ߟߦಽ߆ࠇߡ 1㧦⨶ේ∛㒮ߩ CRC ߣ Q-Pharm ߩ SC ߩ․ᕈᲧセ 㗄⋡ ⾗ᩰ㧔ᢎ⢒㧕 CRC ߩᢎ⢒ ⨶ේ∛㒮 Q-Pharm ⋴⼔Ꮷ⮎ޔᏧ ⋴⼔Ꮷ ⻉࿅ߦࠃࠆᢎ⢒ࠦࠬ Association of Clinical Research Professionals ᵈ 2 㧔ᣣᧄ⥃ᐥ⮎ℂቇળޔᣣᧄ∛㒮⮎Ꮷળޔ (ACRP)߇㐿⻠ߒߡࠆᢎ⢒ࠦࠬ SoCRA ᵈ 1ޔᣣᧄ⋴⼔දળޔᣣᧄකᏧળ߇㐿⻠㧕 CRC ߩ⾗ᩰᐲ ฦ࿅߇ฃ⻠⚳ੌ⠪ߦޟቯ⸽ⴕ⊒ࠍޠ ACRP ߇ Certificate ࠍ⊒ⴕ ╙ IIޔIII ⋧⹜㛎 ╙ IޔII ⋧⹜㛎 ᬺോߩ▸࿐ ㅧ⽼ᄁᓟ⥃ᐥ⹜㛎 ↢‛ቇ⊛ห╬ᕈ⹜㛎 㧔⥃ᐥ⹜㛎ߩ⒳㘃㧕 Ꮢ⽼ᓟ↪ᚑ❣⺞ᩏޔᏒ⽼ᓟ↪ో⺞ᩏ ⮎‛േᘒ⹜㛎 කᏧਥዉߩ⥃ᐥ⹜㛎 ⥃ᐥ⮎ℂ⹜㛎 ᧲੩ㇺਥዉߩ⥃ᐥ⎇ⓥ ᵈ 1㧦SoCRA㧦The Society of Clinical Research Associate, Inc.)ᧄߦࠞࡔࠕޕࠍ⟎ߊ⥃ᐥ⹜㛎ኾ㐷⡯㧔ࠢ࠾ࠞ࡞ࠨ࠴ࠦ࠺ࠖࡀ࠲࡞ࠞ࠾ࠢޔ ࠨ࠴ࠕ࠰ࠪࠛ࠻ߤߥࡖࠫࡀࡑ࠲࠺ޔ㧕ࠍ㙃ᚑߔࠆ㕖༡࿅ޕᣣᧄᡰㇱߪ 2002 ᐕߦ⸳┙ߐࠇߚޕ⇇ߦ 48 ᡰㇱ߇ࠆޕ ᵈ 2㧦ACRP ߪ Association of Clinical Research Professionals ߩ⇛ޕක⮎ຠ‛↢ޔቇ⊛ޔක≮ᯏེߥߤߩ⥃ᐥ⎇ⓥߦᓥߔࠆᛛⴚ⠪ࠍ㙃ᚑߔࠆ࿅ߣߒߡ 1976 ᐕ☨࿖ߦ⸳┙ߐࠇߚ☨ޕ࿖ߣ᰷Ꮊߦᧄࠍᜬߟ߇߽ߦࠕ࠻ࠬࠝޔᡰᚲࠍ⟎ߡࠆޕ 42 J Kyoritsu Univ Pharm 2007. 10 Vol. 3 4/12 原著論文 2㧦Q-Pharm ߩ SC ߩ⡯ോ⸥ㅀᦠ Position Purpose: a. To carry out clinical trial research contributing to better clinical management. b. To aid/assist supervisors to perform correct clinical trial practice and monitoring Major Responsibility Areas: a. To co-ordinate and assist in the execution of trials b. Maintain accurate patient data and ensure completion of CRF c. Collection of specimen specific for clinical trials d. Demonstrate knowledge of aseptic technique and universal precautions when dealing with blood and body products. e. To aid in the smooth running of the research unit. f. Demonstrate the ability to follow written and verbal guidelines and instructions essential for experimental drug trials and clinical research projects g. Demonstrate proficiency in collection of patient data and the ability to work with understanding and co-operation within a team of health care workers h. To actively be involved in research unit meeting i. Responsibility for operation of trial centre on clinical study days j. Maintenance of clinical records k. Maintenance of compliance with study protocol l. Assisting in the management of the clinical trials centre m. Preparation of clinic for trial days n. Taking and recording of clinical observations o. Collection of blood samples by venipuncture p. Assist with the planning and implementation of work instructions for use in the clinical setting. q. Liaise with clinical research associate conducting monitoring activities on behalf of sponsors of clinical trials r. Have sound knowledge on ICH/GCP guidelines ࠆޕPosition Purpose ߩᰣߦߪ⥃ޟޔᐥ⹜㛎⎇ⓥߦ ⨶ේ∛㒮ߦ߅ߌࠆ CRC ᬺോߩਛߦߪ Q-Pharm ߢ 㑐ߔࠆ⍮⼂ࠍᜬߜޔม㧔⹜㛎⽿છකᏧ㧕ࠍߒ ߪ SC ߩᬺോߣߪߐࠇߡߥ߽ߩ߇ߞߚ߃ޕ ߡ⾰ߩ㜞⥃ᐥ⹜㛎ታᣉߩࡑࡀࠫࡔࡦ࠻ࠍⴕ߁ߎ ߫⨶ේ∛㒮ߩ CRC ߪ⹜ޔ㛎ଐ㗬⠪ߦࠃࠆᣉ⸳ㆬቯ ߣޕࠆߡࠇࠊ⻭߇ޠ ߩߚߩ⺞ᩏ⸰߳ߩኻᔕޔIRB ߩߚߩ⾗ᢱߩᢛ ᰴߦ⨶ޔේ∛㒮ߦ߅ߌࠆ╩⠪ߩ CRC ߣߒߡߩᬺ ޔᣣ⒟⺞ᢛߣ㐿᩺ౝ߿⼏㍳ᚑߥߤߩോዪ ോౝኈࠍ 3 ߦ␜ߒޔQ-Pharm ߩ SC ߩޟMajor ᬺോࠍࠣࡦ࠾ࠢࠬޔⵍ㛎⠪ߩࠢ࡞࠻߿ Responsibility AreasߣޠᲧセߒߚ⨶ޕේ∛㒮ߢߪᣣ ⋧⺣ߩኻᔕ⮎ޔ▤ℂ߿⺞ޔCRA ߦࠃࠆࡕ࠾࠲ Ᏹ⸻≮ߩߚߩ⚵❱ߣߩਛߢᴦ㛎ᬺോ㧔╙Τ㨪 ࡦࠣ߳ߩኻᔕ▤ޔᢥᦠ▤ℂߥߤ߇ᐢߊ▸࿐ Φ⋧⹜㛎㧕߇ⴕࠊࠇߡࠆ৻ޕᣇ⥃ޔᐥ⹜㛎ฃ⸤ᯏ ߣߐࠇߡࠆ߇ޔQ-Pharm ߢߪฦᬺോ߇⚦ಽൻߐࠇ 㑐ߢࠆ Q-Pharm ߢߪᣣᏱ⸻≮ߪߥߊ⥃ޔᐥ⹜㛎 ߡ߅ࠅߎࠇࠄߩᬺോߪઁㇱ㐷߇ⴕߞߡߚޕ 㧔ஜᏱੱߪᖚ⠪ߦࠃࠆ╙ IޔΤ⋧⥃ᐥ⹜㛎‛↢ޔ Q-Pharm ߦ߅ߌࠆ SC ߩਥⷐߥᬺോߪ⥃ᐥ⹜㛎㐿ᆎ ቇ⊛ห╬ᕈ⹜㛎‛⮎ޔേᘒ⹜㛎㧕ߦ⋧ᔕߒ⚵❱ߣ ᓟߦ↢ߓࠆࠃ߁ߢࠆޔߚ߹ޕQ-Pharm ߢߪ╙Σ⋧ ࠍᜬߜ⹜ޔ㛎߇ⴕࠊࠇߡࠆ⊛⋡ߦ߁ࠃߩߎޕ ⥃ᐥ⹜㛎߿↢‛ቇ⊛ห╬ᕈ⹜㛎߇߶ߣࠎߤߩߚ ߿⚵❱ⅣႺ߇⇣ߥࠆਔᣉ⸳ߦ߅ߌࠆᴦ㛎ታᣉߩታ ⵍ㛎⠪߆ࠄߩណⴊߪࡌ࠶࠼ࠨࠗ࠼ߢࠨ࠴࠽ 㓙ࠍᲧセߔࠆߎߣߦߪ⥄ߕߣ㒢⇇ߪࠆ߇⑼ޔቇᕈ ࠬ㧔ᣣᧄߢ߁⋴⼔Ꮷ㧕߇ⴕߞߡࠆ⨶ޕේ∛㒮ߢ ߿୶ℂᕈࠍ㊀ⷞߒߟߟวℂൻࠍ࿑ࠆߣ߁ὐߢߪ ߪ╙Τ⋧⥃ᐥ⹜㛎એ㒠ࠍⴕ߁ߚޔᄖ᧪ߢߩᴦ㛎ߩ หߓߥߩߢޔ ᧄ⺰ᢥߢߪᢓ߃ߡਔᣉ⸳ߦ߅ߌࠆ CRC ႐ว CRC ߪᬌᩏㇱ߳ⵍ㛎⠪ࠍ᩺ౝߒ⥃ޔᐥᬌᩏᛛ 㧔SC㧕ߩᬺോౝኈߩᲧセࠍ⹜ߺߚޕ Ꮷ߇ណⴊࠍߔࠆߩ߇᥉ㅢߢࠆޕ 5/12 J Kyoritsu Univ Pharm 2007. 10 Vol. 3 43 Kobayashi A et al. 3㧦 ⨶ේ∛㒮ߩ CRC ߣ Q-Pharm ߩ SC ߩᬺോ Events ⹜㛎ߩḰ ⨶ේ∛㒮ߩ CRC z ⹜㛎කᏧᴦ㛎ଐ㗬⠪ߦࠃࠆᣉ⸳ㆬቯ⺞ᩏ߳ߩኻᔕ z ᴦ㛎ଐ㗬⠪ߣߩ㧝ᰴ 2 ᰴࡅࠕࡦࠣᵈ 1 ߳ߩᔕኻޔ㒮ౝ ߩᴦ㛎දജㇱ⟑߳ߩ೨ㅪ⛊ߣᴦ㛎ታᣉߦะߌߚ⺞ᢛ z IRB ↪ክ⼏↳⺧ᦠ㘃ߩᚑߣ IRB ᆔຬ߳ߩ㈩Ꮣᵈ 2 IRB 㑐ㅪᬺോ z IRB ߩോዪᬺോᵈ㧟 Q-Pharm ߩ SC z ⹜㛎ଐ㗬⠪ߦࠃࠆᣉ⸳⺞ᩏ߿⹜㛎ଐ㗬⠪ߣߩࡅࠕࡦ ࠣኻᔕߪઁㇱ⟑߇ᜂᒰ z SC ߪ Q-Pharm ౝ߅ࠃ߮⹜㛎ߦදജߔࠆ Brisbane ∛㒮ౝ ߩઁㇱ⟑ߣߩㅪ⛊⺞ᢛߪⴕࠊߥ㧔ઁㇱ⟑߇ᜂᒰ㧕 z Project Manager(PM)߇ IRB ↪ክ⼏↳⺧ߩᚑߣὐᬌޕ z Q-Pharm ౝߦ IRB ߪߥߩߢ SC ߦോዪᬺോߪ⊒↢ߒ ߥޕPM ߇㓞ធߔࠆ QMRl ߩ IRB ߳ክ⼏ࠍଐ㗬ߔࠆ z IRB ክ⼏⚿ᨐㅢ⍮ᦠߩ⊒ⴕ ⹜㛎㐿ᆎḰ ⹜㛎㐿ᆎ ⹜㛎ߩታᣉ z ⵍ㛎⠪ࡈࠔࠗ࡞ߩᚑᵈ㧠 z ⮎▤ℂߣᱛ㒢ߔࠆ૬↪⮎ߩࠬ࠻ߩᚑ z ᣉ⸳ౝᬌᩏㇱ㐷ߣߩᬌ࿁ಣℂߣ࠺ࡃߥߤߩ ᛂߜวࠊߖ z ⹜㛎⽿છකᏧߦࠃࠆࠬ࠲࠻ࠕ࠶ࡊࡒ࠹ࠖࡦࠣߩ㐿 ࠍ z ⹜㛎⮎ߩฃ㗔⮎ޔ⑼߳ߩ⺑ z ⵍ㛎⠪ࠬࠢ࠾ࡦࠣ㧔ᴦ㛎⽿છකᏧߩᜰ␜ߦࠃࠆ㧕 z ⵍ㛎⠪߳ߩ⺑ߣหᗧขᓧ߳ߩ┙ળޕขᓧᓟߩᦠ㘃ࠍ ▤▤ℂ z ⹜㛎ታᣉࠬࠤࠫࡘ࡞ߩ▤ℂߣⵍ㛎⠪ߩࠤࠕᵈ 5-1 z CRF ߳ߩ⸥㧔කቇ⊛್ᢿߩࠊߥㇱಽߩߺ㧕 z ⹜㛎ታᣉߦᔅⷐߣߐࠇࠆෳടઁㇱ㐷ߣߩㅪ⛊⺞ᢛ z ේ⾗ᢱߩ㓸ߣ▤ℂ z 㧔㊀◊ߥ㧕ኂ⽎߳ߩኻᔕᵈ 6 z ᧪㒮ߒߥⵍ㛎⠪ߩㅊ〔⺞ᩏޔᖱႎ㓸᧪ޔ㒮ߩᚻ㈩ޔ ⸥㍳▤ z ⹜㛎ଐ㗬⠪㧔CRA㧕ߦࠃࠆࡕ࠾࠲ࡦࠣ߳ߩኻᔕᵈ 7 z IRB ߳ߩႎ๔ᦠ㘃ᚑ㧔⹜㛎⽿છ⠪ࠍ㧕ᵈ 8 z ⴊᶧ↢ࠨࡦࡊ࡞ណขߩߚߩⵍ㛎⠪߳ߩࠟࠗ࠳ࡦࠬ 㧔ណⴊ╬ߪઁߩᜂᒰㇱ㐷ߩᬺോ㧕 z CRF ቢᚑߩߚߩ⹜㛎ଐ㗬⠪(CRA)߳ߩኻᔕ ᴦ㛎ߩ⚳ੌ ⋙ᩏኻᔕ z IRB ክ⼏⚿ᨐㅢ⍮ࠍฃ㗔 z ⵍ㛎⠪ࡈࠔࠗ࡞ߩᚑ z ᱛ㒢ߔࠆ૬↪⮎ࠬ࠻ᚑߩᔅⷐߪߥ z Q-Pharm એᄖߩᬌᩏㇱ㐷ߣߩᬌ࿁ಣℂߣ࠺ࡃ ߥߤߩᛂߜวࠊߖ z ࠬ࠲࠻ࠕ࠶ࡊࡒ࠹ࠖࡦࠣߦ࠴ࡓࡔࡦࡃߣߒߡ ෳട z ⹜㛎⮎ߩฃ㗔▤▤ℂߪ⮎Ꮷߩᬺോ z ࠬࠢ࠾ࡦࠣߪࠢ࡞࠻ࠝࡈࠖࠨ߇ⴕ߁ z ⹜㛎⽿છකᏧ߇ⵍ㛎⠪ߦ⹜㛎ࠍ⺑ߒหᗧࠍขᓧ z ⹜㛎ታᣉࠬࠤࠫࡘ࡞ߩ▤ℂߣⵍ㛎⠪ߩࠤࠕᵈ 5-2 z CRF ߳ߩ⸥ߣౝኈ⏕ z ⹜㛎ታᣉߩࡑࡀࠫࡔࡦ࠻㧔⹜㛎⽿છ⠪ࠍ㧕 z ේ⾗ᢱߩ▤▤ℂߪઁㇱ⟑߇ᜂᒰ z ኂᔕ߳ߩኻᔕߣ⸥㍳ᵈ 6 z ᧪㒮ߒߥⵍ㛎⠪ߩㅊ〔⺞ᩏޔᖱႎ㓸᧪ޔ㒮ߩᚻ㈩ޔ ⸥㍳▤ z ࡕ࠾࠲ࡦࠣ߳ߩኻᔕᵈ 7 z IRB ߳ߩႎ๔ᦠ㘃ᚑ㧔⹜㛎⽿છ⠪ࠍ㧕ᵈ 8 z ⴊᶧ↢ࠨࡦࡊ࡞ߩណข z PM ߇ CRF ቢᚑߩߚߩ⹜㛎ଐ㗬⠪(CRA)߳ߩኻᔕޔ CRC ߪ PM ࠍ z ઁㇱ⟑㧔Archive㧕߇ᔅ㗇ᢥᦠ߅ࠃ߮ߔߴߡߩᴦ㛎㑐ㅪᢥ ᦠࠍ▤▤ℂ z ᔅ㗇ᢥᦠ߅ࠃ߮ߔߴߡߩ⹜㛎㑐ㅪ⸥㍳ᢥᦠߩ▤▤ℂ z ᣉ⸳߇▤▤ℂߔࠆએᄖߩᴦ㛎㑐ㅪᢥᦠ⹜ޔ㛎⮎ઁߩ ࡑ࠹ࠕ࡞ࠍᴦ㛎ଐ㗬⠪߳ළ z ᣉ⸳߇▤▤ℂߔࠆએᄖߩ⹜㛎㑐ㅪᢥᦠ⹜ޔ㛎⮎ઁߩ z ⹜㛎⽿છකᏧ߇⹜㛎✚ႎ๔ᦠࠍᚑޔSC ߪᚑࠍ ࡑ࠹ࠕ࡞ߩὐᬌ⹜ޔ㛎ଐ㗬⠪߳ළ z ઁᣉ⸳⥃ᐥ⹜㛎߇ᄙߊ⹜ޔ㛎✚ႎ๔ᦠߪᚑߒߥޕ z ߘߩઁߩႎ๔ᦠ㘃ߩᚑߣ IRB ߳ߩឭ㧔⹜㛎⽿છක z ႎ๔ᦠ㘃ߩᚑߣ IRB ߳ߩឭ㧔⹜㛎⽿છකᏧ߳ߩ ߣߒߡ㧕 Ꮷ߳ߩߣߒߡ㧕 z ⋙ᩏᩏኤ╬ᵈ 9-1 ߳ߩኻᔕ z QAU ߇⋙ᩏᩏኤ╬ᵈ 9-2 ߳ߩኻᔕޔSC ߪ QAU ࠍ ᵈ 1㧦㧝ᰴࡅࠕࡦࠣߢߪ⹜㛎ଐ㗬⠪߇ CRC ߳ߩᴦ㛎ౝኈࠍ⺑⺑ޕࠍฃߌߚ CRC ߪ⹜㛎ߦ㑐ㅪߔࠆㇱ⟑㧔⋴⼔ㇱ⮎ޔ⑼ޔᬌᩏ⑼ޔ✢⑼ޔ⑼ࡆࡂޔක≮ㅪ៤ㇱޔ ක⑼ޔᐼോ⺖ߥߤ㧕ߦ⹜㛎ߩ⇛ࠍ⺑ߒޔታᣉߩน⢻ᕈࠍᛠីߔࠆޕ㧞ᰴࡅࠕࡦࠣߢߪ⹜㛎ଐ㗬⠪߇කᏧ⼔⋴ޔᏧ⮎ޔᏧ⥃ޔᐥᬌᩏᛛᏧޔᐼോ⺖߳ߩ⹜㛎ౝኈࠍ ⺑ޕ ᵈ 2㧦↳⺧ᦠ㘃ߩ࠴ࠚ࠶ࠢ▚࠻ࠬࠦޔ⺑ޔᢥᦠߣหᗧᦠᚑදജޔකᏧߩጁᱧᦠᴦ㛎දജ⠪ߩࠬ࠻ᚑޔᐢ๔߿ෳടࠞ࠼ᚑߥߤ ᵈ㧟㧦ᴦ㛎⽿છ⠪߳ߩ㐿ㅢ⍮ޔክ⼏↳⺧ᦠ㘃ߩ㈩Ꮣ⼏ޔ㍳ߩᚑߥߤ㧕 ᵈ㧠㧦ฦᬌᩏߩ⺧᳞વ߿ಣᣇ▐ߥߤࠬࠤࠫࡘ࡞ߦᴪߞߚ࠶࠻ߩ↪ᗧ㧕 ᵈ 5-1㧦ⵍ㛎⠪ߩ⺞⏕┙ߩ߳≮⸻ޔળߦ࡞ࡘࠫࠤࠬޔᴪߞߚⷰኤᬌᩏߩ⺑ߣᬌᩏቶ߳ߩࠟࠗ࠼ޔᰴ࿁ฃ⸻ࠬࠤࠫࡘ࡞ߩ⺞ᢛ▤ℂߥߤޕ ᵈ 5-2㧦ⵍ㛎⠪ߩ⺞⏕┙ߩ߳≮⸻ޔળߦ࡞ࡘࠫࠤࠬޔᴪߞߚⷰኤᬌᩏណⴊ↢ࠨࡦࡊ࡞ߩណขޔᰴ࿁ฃ⸻ࠬࠤࠫࡘ࡞ߩ⺞ᢛ▤ℂᤨ⥃ޔ⡯ຬ߳ߩᜰ␜ߥߤ ᵈ 6㧦ⵍ㛎⠪ኻᔕޔකᏧ߳ߩㅪ⛊ޔᖱႎ㓸ޔᴦ㛎ଐ㗬⠪߳ߩႎ๔ߩޔ㒮ౝ߳ߩㅪ⛊⸥ޔ㍳ߣߘߩ▤ߥߤ ᵈ 7㧦ࡕ࠾࠲ࡦࠣࠬࠤࠫࡘ࡞ߩ▤ℂޔේ⾗ᢱߩ↪ᗧߩ߳ࠛࠢޔኻᔕޔᴦ㛎⽿છ㧔ಽᜂ㧕කᏧ߳ߩㅪ⛊ ᵈ 8㧦ోᕈᖱႎ⛯⛮ޔክ⼏ޔᴦ㛎ታᣉ⸘↹ᦠߩ৻ㇱᄌᦝޔᴦ㛎ಽᜂකᏧߩㅊടߣ㒰ࠣࡦ࠲࠾ࡕޔႎ๔ߩઁߩߘޔシᓸߥ㗄ߥߤ ᵈ 9-1㧦⹜㛎ଐ㗬⠪ޔ㒮ౝߩ⋙ᩏㇱ㐷ⷙޔᒰዪߦࠃࠆ⋙ᩏᩏኤ߳ߩኻᔕ 3. ⹜㛎⽿છකᏧߣࠦ࠺ࠖࡀ࠲ߣߩ㑐ଥ ⽿છකᏧࠍൕߡ߅ࠅ Q-Pharm ߦߪᏱൕߒߡߥ Q-Pharm ߩ⹜㛎⽿છකᏧߪᣣᧄߩ⹜㛎⽿છ㧔ಽ ⹜ޕ㛎ታᣉᒰᣣ㧔ᄢㅳ 3 ᣣ㧕ߩᦺ Q-Pharm ߦ ᜂ㧕කᏧߦᲧߴߡ⹜㛎ታᣉ⸘↹ᦠ㧔ࡊࡠ࠻ࠦ࡞㧕 ൕߒޔ1 ᣣਛᣉ⸳ౝߢ⹜㛎ߦ៤ࠊߞߡࠆ╩ޕ⠪ ߳ߩℂ⸃ᐲ߇ᷓߊޔᴦ㛎ߩਛᔃੱ‛ߣߒߡߩሽᗵ ߇⎇ୃߒߡߚ 3 ࡨߩ㑆ߦ 18 ߩࡊࡠ࠻ࠦ࡞ 㧔╙ ߇㜞ޕQ-Pharm ߢߪࡄ࠻࠲ࠗࡓකᏧ 4 ฬ߇⹜㛎 Σ⋧⥃ᐥ⹜㛎ߣ BE ⹜㛎㧕ߩ⹜㛎߇ㅴࠄࠇߡߚ 44 J Kyoritsu Univ Pharm 2007. 10 Vol. 3 6/12 原著論文 ߇ߩߘޔᄙߊࠍ৻ੱߩᅚᕈකᏧ߇⹜㛎⽿છකᏧࠍോ ߆ࠄߢࠆࠊ߆ߥ߈ߢ߇ࠢ࠶ࠚ࠴࡞ࡉ࠳ߒ߆ߒޕ ߡߚޕQ-Pharm ߢߪⵍ㛎⠪ߦኻߔࠆ⹜㛎ߩ⺑ ࠅߦ⮎ߦ߁ࠃߥ߈߇ࠬࡒޔ࠴ࡘࡉߦࠪ࡞ ߣหᗧขᓧߪߎߩකᏧߣⵍ㛎⠪ߩ㑆ߢⴕࠊࠇߡ߅ ࠍߪࠅᐲ߽࠴ࠚ࠶ࠢࠍߒߚࠅ࠴ࡘࡉࠍ⦡ಽߌ ࠅޔSC ߪ․ߦ㑐ਈߒߡߥ⨶ޕේ∛㒮ߢߪ⹜㛎 ߒߚࠅࠢ࠶ࠚ࠴ޔᣇᑼߩࠬ࠻ࠍߞߚࠅߣࡒࠬ㒐 ⽿છ㧔ಽᜂ㧕කᏧ߇ⵍ㛎⠪ߦ⹜㛎ߩ⇛ࠍ⺑ࠍߒ ᱛ╷߇ᚲߢޘฃߌࠄࠇޔ1 ੱ⮎Ꮷߢ߽චಽ ߚᓟޔㅢᏱ CRC ߇⿷⺑ࠍߔࠆߩߢ╩⠪ߦߣߞ ࡒࠬߥߊ⺞ࠍߒߡࠆᆫ߇ශ⽎⊛ߢߞߚ㧔߹ ߡߎࠇߪએᄖߢߞߚ⸒ޕ឵߃ࠇ߫ޔQ-Pharm ߩ ߢ 1 ᐲ߽ࡒࠬߪߥߣߎߣߢߞߚ㧕ߡߒ↪ޕ කᏧߪ⥄ಽߩ∛㒮ߢߩ⸻≮ᬺോߣ Q-Pharm ߢߩᴦ ࠆ⮎▤ℂ߽ಣᣇ▐߽ᒻᑼ߇߹ߞߡࠆ߽ߩ 㛎ᬺോᣇࠍᛴ߃ߡࠆ߽ߩߩࠍࠄࠇߎޔหᤨਗⴕ ߢߥߚ⥄ಽ߇߿ߔࠃ߁ߦᚑߒ⹜ޔ㛎⽿ ⊛ߦߎߥߔߩߢߪߥߊޔᣣᲤߦ⏕ߦಽߌߡߘࠇߙ છකᏧߩࠨࠗࡦࠍ߽ࠄ߃߫ේ⾗ᢱߣߒߡࠄࠇ ࠇߦᓥߒߡࠆޕ ࠆߣ߁ࠪࠬ࠹ࡓߥߩߢᴦ㛎Ḱߪߟ߽ᚻᣧ ⹜㛎ߪㅢᏱᦺ 6 ᤨ೨߆ࠄࠬ࠲࠻ߒߡߚ⹜ޕ㛎 ߆ߞߚޕᴦ㛎⮎⺞ᓟߩᱷ⮎ޔⓨࠪ࠻ළߪᣣᧄ ታᣉਛߪᐲߣߥߊ SC ߇⹜㛎ቶਛᄩߩࡉࠬߦ⹜ ߩࠃ߁ߦ෩ߒߊߥߊޔ㧑↪ߩ⸥㍳ߩߺߢ 1 ㍤න 㛎࠴ࡓࡔࡦࡃࠍถ㓸ߒޔฦಽᜂᬺോࠍ⏕ߒޔ ߢߩ⸥㍳ߪขߞߡߥ߆ߞߚߥߪߢߡో߽߆ߒޕ ᜰ␜ࠍߔߥߤ⹜ޔ㛎ߩࠬࡓ࠭ߥㅴⴕߩߚߦ߆ ߇ࡊࡠ࠻ࠦ࡞ߦࠃߞߡߪ⮎Ꮷ߇⸥㍳ࠍᱷߖ ߥࠅߩ᳇㈩ࠅࠍߒߡߚ ࠼࠶ࡌߪߦᤨޕ1 ߟ 1 ߟࠍ ߫ⵍ㛎⠪߆ࠄߩළ⮎ߪ⎕᫈ߢ߈ࠆ߽ߩ߽ࠅᄢ ࠅࠬ࠲࠶ࡈ߿ⵍ㛎⠪ߦჿࠍ߆ߌߟߟ㧔ߎߩᤨ∝ޔ ᄌᗧᄖߢߞߚޕQ-Pharm ߢߪ 1 ࡨߦ 1 ࿁ฦࡈࡠ ႎ๔ᦠߦᔅⷐߥᖱႎࠍࠗࡦ࠲ࡆࡘߒߡࠆ㧕ޔ ࠕߦ⸳⟎ߐࠇߡࠆ✕ᕆࠞ࠻ߩὐᬌࠍߒߡࠆޕ ోߩㅴⴕࠍ▤ℂ⛔ߒߡߚߦ⊛⚳ᦨߒ߆ߒޕක ṛᦼ㑆ਛ╩⠪ߪὐᬌߦᔅߕหⴕߐߖߡ߽ࠄޔ Ꮷ߇್ᢿߔߴ߈ߣߎࠈߢߪᔅߕ⹜㛎⽿છකᏧ߇ⷐ ኂ⽎⊒↢ߦ߃ߚ⮎▤ℂ߽㛎ߢ߈ߚࠬࠖ࠺ޕ ᚲߦᜰ␜ࠍߒߦ࠭ࡓࠬޔᴦ㛎ߩࠬࠤࠫࡘ࡞߇ ࡐ࠲ࠗࡊߩ㎛ࠍ↪ߒ⮎ߩ⋑㔍߿ੂ↪߇ߥࠃ ታⴕߐࠇߡߚޕ ߁ߦ㎛ߦ․ߩ࠽ࡦࡃ߇߰ߞߡࠅ߇⺕ޔ㐿ߌ㐽 ⨶ේ∛㒮ߢ CRC ࠍൕߡࠆ╩⠪ߦߪ⹜ޔ㛎 ࠍߒߚ߆߽⸥㍳ߔࠆࠃ߁▤ℂ߇߈ߜࠎߣߥߐࠇ ࠴ࡓࡔࡦࡃ߇ᣉ⸳ౝߩห৻ࡈࡠࠕߢ৻ߣߥ ߡߚߒ߆ߒޕᐘ߹ߢෂ㒾ࠍߊ⽎߇߶ߣࠎ ࠅㅪ៤ߒߡޔᄙߊߩⵍ㛎⠪ߦࠃࠆ⹜㛎ࠍല₸⊛ߦㅴ ߤߥ߆ߞߚߎߣޔQ-Pharm ߪ RBH ∛㒮⟲ౝߦࠅ ߡࠆ⁁ᴫߦធߒߚߩߪೋߡߢߞߚߩߢᭂ ਁ߇৻㊀◊ߥኂ⽎߇߈ߚᤨߦߪ∛㒮߆ࠄ ߡශ⽎⊛ߢߞߚ⹜ߥ߁ࠃߩߎޕ㛎ታᣉߢߪߘߩ ࠬࠠࡘ࠴ࡓ߇߿ߞߡ᧪ߡㄦㅦߥಣ⟎ࠍߔࠆ ႐ߩ⁁ᴫߦᔕߓߚ್ᢿߦၮߠߚᜰ␜߇น⢻ߢ ߦߥߞߡࠆߎߣߦࠃࠅ✕ᕆࠞ࠻ౝߩ⮎ߪ ࠅ੍ޔ᷹ࠍ߃ߚ⓭ὼߩᘒߦኻߔࠆහᐳߩℂ⸃ޔ ↪ߐࠇߕᦼ㒢ಾࠇߦߥࠆ߽ߩ߇ᄙߣߩߎߣߢ ㄦㅦߥ್ᢿߣⴕേ߇น⢻ߢࠈ߁ߚߒ߁ߎޕኻᔕߪ ߞߚޕ ߤߩᲑ㓏ߩᴦ㛎ߢ߽࿑ࠆߎߣ߇ᔅⷐߢࠆߣᕁࠊ ࠇࠆޕ ⠨ኤ 4. ⮎Ꮷߩᬺോ ⨶ේ∛㒮ߩ⮎ㇱ߇ᴦ㛎⮎ࠍขᛒ߁ߩߣߪ⇣ ࠊ߇࿖ߢޟක⮎ຠߩ⥃ᐥ⹜㛎ߩታᣉၮḰ߇ޠᴺ ߥࠅޔQ-Pharm ߢߪᣣᏱ⸻≮ߪߥߚᴦ㛎⮎ߛ ൻߐࠇߡ߆ࠄᣢߦ 10 ᐕ߇⚻ㆊߒߚޕICH-GCP ߩዉ ߌࠍᛒߞߡࠆޕ1 ੱߩ⮎Ꮷ߇ోߡߩᴦ㛎⮎ߩ⺞ એ㒠ޔ⇇⊛ߦߪᴦ㛎ߩࠣࡠࡃ࡞ൻߣฦ࿖ߢߩ ߣ▤ℂߩᬺോࠍછߐࠇߡࠆޕ㧝ੱ⮎Ꮷߩ ⹜㛎࠺࠲ߩᣂ⮎⸵นᛚߩߚߩ↪ൻߩะ ߚ⺞ߩ࠳ࡉ࡞࠴ࠚ࠶ࠢߪߢ߈ߥߩߢೋ╩ ߇߹ߔ߹ߔჇടߒߡࠆޔߡߒߘޕㄭᐕߢߪ᰷☨⻉ ⠪ߪ㆑ᗵࠍⷡ߃ߚ⨶ޕේ∛㒮ߩ⮎ㇱߢߪᴦ㛎⮎ ࿖ධࠕࡔࠞ᧲᰷⻉࿖߫߆ࠅߢߥߊ᧲ޔධࠕࠫ ⺞ߢߪੱ߽ߩ࠴ࠚ࠶ࠢ߇ࠅ⺞ࠍߒߡࠆ ࠕ⻉࿖߽ࠣࡠࡃ࡞ᴦ㛎ߦෳ↹ߒᆎߡࠆ৻ޕᣇޔ 7/12 J Kyoritsu Univ Pharm 2007. 10 Vol. 3 45 Kobayashi A et al. ࠊ߇࿖ߪߥ߆ߥ߆ࠣࡠࡃ࡞ᴦ㛎ߩખ㑆ࠅ߇ߢ ࠨ࠴㧕ߢࠆޕ㐿⊒Ბ㓏ߢഃࠄࠇߚฦ⒳ߩᖱႎ߇ ߈ߦߊߩ߇⁁ߢࠆߡߒߘޕᶏᄖߩ⮎ડᬺߩ ᭂߡ⍴ߊⷐ⚂ߐࠇޔឝタߐࠇߡࠆߩ߇ක⮎ຠߩ ᄙߊߪߢߪᣣᧄࠍ㒰ߚ⻉࿖ߢᴦ㛎ࠍታᣉߒ ᷝઃᢥᦠߢࠅߪߦߎߘޔㆡᱜ↪ߩߚߩၮᧄ⊛ ߡࠆޔߚ߹ޕᣣᧄߩᄢᚻ⮎ડᬺ߽ᶏᄖఝవߢᴦ ᜰ㊎߇␜ߐࠇߡࠆ⮎ޕᏧࠍ⮎ቇᛛⴚ⠪߇න 㛎ࠍㅴࠆะ߇Ⴧ߃ߟߟࠆߚߒ߁ߎޕᣣᧄ߆ࠄ ߦᷝઃᢥᦠߩ⸥タߩℂ⸃ߩߺߦ⇐߹ࠄߕ⸥ޔタᖱ ߩᴦ㛎㔌ࠇޔᴦ㛎ߩⓨᵢൻ߇ㅴߎߣߪߪߡ߭ޔ ႎ߇ߤߩࠃ߁ߥ߆ߚߜߢߦ߁ࠃߩߤޔഃߐࠇࠆ߆ ᣣᧄߩᖚ⠪߇⇇ᦨవ┵ߩ⮎‛ᴦ≮ࠍฃߌࠄࠇߥ ࠍℂ⸃ߒߡ߅ߊߎߣߪޔᓐࠄߩᵢኤജߩᩰᲑߩะ ߎߣߦ❬߇ࠅ߆ߨߥޕෘ↢ഭ⋭߅ࠃ߮ᢥㇱ⑼ ࠍଦߒޔⓥᭂ⊛ߦߪ⾰ߩ㜞ක≮ߩଏ⛎ߦ❬߇ࠆߣ ቇ⋭ߪߎߩኻ╷ߣߒߡᐔᚑ 15 ᐕߦ ޟᴦ㛎ᵴᕈൻ 3 ࡨ ⠨߃ࠄࠇࠆޕᓟ␠ળ߆ࠄ㜞⹏ଔࠍฃߌࡠࠣޔ ᐕ⸘↹ޔߡ┙ࠍޠᣣᧄߩᴦ㛎ⅣႺߩᢛࠍ࿑ߞߡ߈ ࡃ࡞ᴦ㛎߽ⴕᓧࠆੱ᧚ߩ⢒ᚑߩߚߦ♽⮎ޔᄢቇ ߚޔߚ߹ޕᐔᚑ 19 ᐕ 4 ߆ࠄߪᦝߦޟᣂߒᴦ㛎 ߦ߅ߌࠆ⥃ᐥ⹏ଔ㑐ㅪߩ⎇ⓥᢎ⢒ᵴേߩ㊀ⷐᕈߪ ᵴᕈൻ 5 ࡨᐕ⸘↹ࠍޠឭ᩺ߒޔᣣᧄߦ߅ߌࠆක⮎ຠ ৻ጀ㜞߹ࠆߣᕁࠊࠇࠆޕ એߩ⠨߃ߦ┙ߜ┙⮎⑼ᄢቇߪᐔᚑ 16 ᐕ㧠ޔ ߩ⥃ᐥ⹏ଔᵴേߩല₸ൻߣ࿖㓙⊛⺞ߦߌߚฦ ઁᄢቇߦవ㚟ߌߡ⥃ޟᐥ⮎‛⹏ଔቇ⻠ᐳࠍޠഃ⸳ߒ ⒳ߩᣉ╷ࠍ⻠ߓߟߟࠆޕ ක⮎ຠߪᧄ⾰⊛ߦߪੱ⒳߿ၞᕈࠍࠊߥੱ ߚޕᒁ߈⛯߈ޔ࿖㓙⊛ⷞ㊁߆ࠄ⥃ᐥ⮎‛⹏ଔߩቇⴚ 㘃ㅢߩ⽷↥ߢࠆߩߢߥ߁ࠃߩߎޔක⮎ຠ㐿⊒ߩ ⎇ⓥߣੱ᧚⢒ᚑࠍ࿑ࠆ⋡⊛ߢᐔᚑ 17 ᐕ 6 ࠝࠬ ࠣࡠࡃ࡞ൻ߿⥃ᐥㆡ↪ߩㅢൻߪ․ቯߩⷐ࿃ߦ ࠻ࠕߩࠢࠗࡦ࠭ࡦ࠼ᄢቇߣቇⴚឭ៤ᄾ⚂ ၮߠߊ߽ߩߢߥߌࠇ߫ᤚߐࠇߡὼࠆߴ߈߽ߩߢ ࠍ✦⚿ߒߚޕ ․ߦࠝࠬ࠻ࠕߦ⌕⋡ߒߚߩߪᰴߩℂ↱ߦ ࠅߩߎޔะߪᓟ߽৻ጀㅴߣ⠨߃ࠄࠇࠆޕᴦ 㛎ߩⓨᵢൻࠍ㒐߉ޔᴦ㛎ߩࠣࡠࡃ࡞ൻߩᵹࠇߦਸ਼ ࠃࠆޕ ࠆߎߣߪᣣᧄߩක≮ߦߣߞߡߪᄢ߈ߥ⺖㗴ߢࠆ 1㧕ࠝࠬ࠻ࠕߩකቇࡃࠗࠝࠨࠗࠛࡦࠬߩ ࡌ࡞ߪ㜞ߎߣޕ ߇ࠍࠇߎޔน⢻ߦߔࠆߚߦߪޔᣣᧄએᄖߩᴦ㛎Ⅳ Ⴚ߿ක≮ᢥൻࠍℂ⸃ߒߡᣣᧄߩක≮ߣߩ⺞ࠍ ഃ⮎⎇ⓥߢߪߎࠇ߹ߢߦᐞߟ߽ߩᚑᨐࠍߍ ࿑ߞߚࠅ࡞ࡃࡠࠣޔᴦ㛎ࠍផㅴߢ߈ࠆੱ᧚ࠍᣣᧄ ߡ߈ߡࠆޕば∛ᴦ≮⮎ߣߒߡߩ࠴࠙ࡓߩ⊒ޔ ߢ⢒ᚑߔࠆߎߣ߇ᔅⷐߢࠆޕ ࠗࡦࡈ࡞ࠛࡦࠩᗵᨴᴦ≮ߩߚߩࡁࠗࡒ࠾ ޟක⮎ຠ㐿⊒ߪߣޠၮ␆⎇ⓥ߆ࠄ↢߹ࠇࠆᣂⷙ↢ ࠳ 㒖 ኂ ⮎ ߩ ഃ ⮎ ⎇ ⓥ ޔB.J.Marshall ߣ ‛ᵴᕈ‛⾰ߩක≮߳ߩᔕ↪․ᕈࠍᭂޔක⮎ຠߩ J.R.Warren ਔඳ჻ߦࠃࠆࡋࠦࡃࠢ࠲ࡇࡠ ㆡᱜ↪ߩߚߩᖱႎࠍഃߔࠆߎߣߢࠆޕหᤨ ߩ⊒ߣᶖൻᕈẩ≌ߦኻߔࠆᣂߚߥᴦ≮ᴺߩ㐿 ߦޔක⮎ຠߣߒߡߩຠ⾰⏕ߣቯଏ⛎߇น⢻ߥᛛ ⊒ߥߤߪߘߩ৻ߢࠆޕ ⴚࠍ㐿⊒ߔࠆߎߣߢ߽ࠆޕ 2㧕ࠝࠬ࠻ࠕߪ࿖㓙ᴦ㛎ߩ⚻㛎߇⼾ንߢࠆ ක⮎ຠߩ⎇ⓥ㐿⊒ࡊࡠࠬߩਛߢᴦ㛎ߪක⮎ຠ ㆡᱜ↪ߦᔅⷐߥᖱႎࠍഃߔࠆࠬ࠹࠶ࡊߢࠅޔ ߎߣޕ ࠝࠬ࠻ࠕߩකቇක≮ᢥൻߪ⧷࿖ߩᒝ ᣂ⮎㐿⊒ᵴേߩਛᩭߣ⟎ߠߌࠄࠇࠆޕᣣᧄߩ⮎♽ ᓇ㗀ࠍฃߌߡ߅ࠅ⥃ޔᐥ⎇ⓥߩ⑼ቇᕈߣ୶ℂᕈߦ ᄢቇߢߪഃ⸳એ᧪⮎ޔᏧ㙃ᚑߦട߃ߡᣂ⮎ߩ⎇ⓥ 㑐ߒߡߪ ICH ߩᕁᗐߣታ〣ࠍขࠅࠇߡࠆޕᣂ 㐿⊒ߦ㑐ࠊࠆቇⴚ⎇ⓥࠍዷ㐿ߒߡ߈ߚߪࠇߎޕ⇇ ⮎㐿⊒߇น⢻ߥⷙᮨߩ⮎ડᬺߪߥ߽ߩߩޔ ߦߪ㘃ࠍߥ․⦡ߢࠆ‛⮎ޔࠄ߇ߥ⸒ߪߣޕ ࠝࠬ࠻ࠕߪߎࠇ߹ߢߦ߽࿖㓙ᴦ㛎ߦⓍᭂ ߩ⥃ᐥ⹏ଔߦ㑐ࠊࠆ⎇ⓥ߿ᢎ⢒ᵴേ߇⋓ࠎߦㅴ ⊛ߦෳടߒߡ߈ߡࠆ☨ޕ࿖ NIH ߦ⊓㍳ߐࠇߡ ࠄࠇߡ߈ߚߣߪ⸒߇ߚߩ߽⁁ߢࠆޕ ࠆ࿖㓙⊛⥃ᐥ⹜㛎ᢙߢߺࠆߣࠝࠬ࠻ࠕ ᴦ㛎ࠍ⮎‛ߩ⥃ᐥ⹏ଔߪ⥄ὼ⑼ቇߣੱᢥ⚻ ߪ 87 ࠞ࿖ਛ 10 ⇟⋡ߦࡦࠢߐࠇߡࠆޕ࿃ߺߦޔ ᷣ୶ℂߩࠃ߁ߥ␠ળ⑼ቇߣߩ⛔วߩߦᚑࠅ┙ߟ ᣣᧄߪ╙ 60 ߢࠅ㖧࿖ޔบḧޔࠕࠪࡑޔ ᅏߩᷓቇⴚ⎇ⓥᵴേ㧔ࡅࡘࡑࡦࠨࠗࠛࡦࠬ 㚅᷼ޔਛ࿖߽ࠅࠃࠕࠪࡀ࠼ࡦࠗޔਅߦࠆ 2㧕ޕ 46 J Kyoritsu Univ Pharm 2007. 10 Vol. 3 8/12 原著論文 ᴫߣ߁ශ⽎߇ࠆޕ 3㧕ࠝࠬ࠻ࠕߪ⧷⺆ࠍᲣ࿖⺆ߣߒ᧲߽߆ߒޔ 2㧕Q-Pharm ߩ SC ߩᬺോߩ▸࿐ߪਥߣߒߡ⥃ᐥ⹜ ධࠕࠫࠕߩ৻ⷺߦ⟎ߒߡࠆߎߣޕ 㛎㐿ᆎએᓟߦ㒢ቯߐࠇߡࠆߩߦኻߒ⨶ޔේ∛ ࠝࠬ࠻ࠕߪ⧷⺆ߩ৻࿖ߢࠅߥ߇ࠄ ࠕࠫࠕ⻉࿖ߩㄭ㓞ߢࠅޔᄙߊߩࠕࠫࠕੱ߇ 㒮ߩ CRC ߪᴦ㛎ᄾ⚂એ೨ߩᲑ㓏߆ࠄᴦ㛎⚳ੌޔ ߒߡࠆ☨ޔߚ߹ޕ࿖ߩࡂࡢࠗᎺࠍ㒰ߌ߫ᣣᧄߦ ⋙ᩏ߹ߢࠎߢ߅ࠅޔᬺോ▸࿐߇ᐢޕ ᦨ߽ㄭ⧷⺆ࠍᲣ࿖⺆ߣߔࠆᎿᬺ࿖ߢࠆࠣޕ 3㧕Q-Pharm ߩ SC ߦߪ⡯ോ⸥ㅀᦠ߇↪ᗧߐࠇߡ ࡠࡃ࡞ᴦ㛎ߢ↪ࠄࠇࠆၮᧄ↪⺆ߪ⧷⺆ߢ ࠆ߇⨶ޔේ∛㒮ࠍߡᣣᧄߩᴦ㛎ᣉ⸳ߩ CRC ࠆޕ ߦߪ⡯ോ⸥ㅀᦠ߇↪ᗧߐࠇߡࠆߣߎࠈࠍߥ ޕ ࠝࠬ࠻ࠕߩਛߢឭ៤వߣߒߡ․ߦࠢࠗ 4㧕Q-Pharm ߢߪ㧝ߟߩࡈࡠࠕౝߢ࠴ࡓࡔࡦࡃ ࡦ࠭ࡦ࠼ᄢቇࠍㆬࠎߛߩߪޔਥⷐ 3 ㇺᏒߦࠆක ߇ല₸⊛ߦㅪ៤ߒߡ⹜㛎ᬺോࠍㆀⴕߢ߈ࠆല₸ ⮎⑼ቇ㑐ㅪᣉ⸳ߩ೨⺞ᩏࠍⴕߞߚ⚿ᨐߩߎޔᄢቇ ⊛ߥ⚵❱ㆇ༡߇ߣࠄࠇߡࠆ৻ޕᣇ⨶ޔේ ߅ࠃ߮㑐ㅪᣉ⸳ߦ߅ߌࠆක⮎ߩ⎇ⓥᢎ⢒ޔᄢ ∛㒮ߪޔᣣᏱ⸻≮ࠍ⋡⊛ߦࠄࠇߚ⚵❱ㆇ༡ ቇ㑐ㅪ∛㒮ߣ⥃ᐥ⹜㛎ᣉ⸳߇ᦨ߽⦟ߊᢛߞߡ߅ࠅޔ ߩਛߢᴦ㛎ᬺോࠍⴕߞߡࠆߚޔCRC ߦ⺖ ┙⮎⑼ᄢቇߣߩࡄ࠻࠽ߣߒߡ⋧ᔕߒߣ್ ߖࠄࠇߡࠆ㒮ౝߢߩㅪ⛊⺞ᢛ⊛ߥᬺോߪ߆ߥ ᢿߐࠇߚ߆ࠄߢࠆޕ ࠅᄙޕ 5㧕Q-Pharm ߩ⹜㛎⽿છකᏧߪ⹜㛎ࡊࡠ࠻ࠦ࡞ߩ ᧄႎᢥߩౝኈߪᣣᧄߩ⨶ේ∛㒮ߣࠝࠬ࠻ ౝኈࠍࠃߊℂ⸃ᛠីߒߡ߅ࠅ⥄ޔಽߩ⸻≮ᬺ ࠕߩ Q-Pharm ߢߩ⮎‛⥃ᐥ⹏ଔ⹜㛎ߦ߅ߌࠆ CRC ോߣ Q-Pharm ߢߩ⥃ᐥ⹜㛎ᬺോߣࠍ⏕ߦಽ㔌 ߩᬺോࠍᲧセߒߚ߽ߩߢࠅߩߎޔᬌ⸛⚿ᨐߪᔅߕ ߐࠇߡࠆ⥃ޕᐥ⹜㛎ߩ႐ߢߪ⹜㛎ታᣉߦᔀ ߒ߽ᣣᧄߣࠝࠬ࠻ࠕߩ CRC ߩᬺോ৻⥸ߦᄖ ߒ⊒ࠍࡊ࠶ࠪ࠳ޔើߒߡ߅ࠅޔCRC ߣߩ ᝌߢ߈ࠆߣߪ⸒߃ߥ৻ޔߚ߹ޕᣇߪ╙Τ, Υ⋧⥃ ㅪ៤߽ࠃޕᣣᧄߢߪ⸻≮ߣᴦ㛎ࠍหᤨ૬ⴕߐ ᐥ⹜㛎ࠍਛᔃߣߒߚᴦ㛎ታᣉߩᣉ⸳ߢࠅઁޔᣇߪ ߖߡࠆ⹜㛎⽿છකᏧ߇ᄙޕ ╙Σ⋧⥃ᐥ⹜㛎߿↢‛ቇ⊛ห╬ᕈ⹜㛎⥃ޔᐥ⮎ℂ⹜ 6㧕⮎ㇱߦ߅ߡߪ⮎ޔߩ▤ឭଏ▤ℂᠲ 㛎ࠍฃ⸤ߒߡታᣉߔࠆᯏ㑐ߥߩߢ⥃ޔᐥ⹜㛎ታᣉߩ ߪ⨶ේ∛㒮ߩᴦ㛎ߦ߅ߌࠆࠃࠅ◲⇛ൻߐࠇߡ ⅣႺߦߪ⇣ߥࠆ㕙߇ࠆ⹜ޔߒ߆ߒޕ㛎ߩ⒳㘃߇ ࠆޕ ⇣ߥߞߡߡ߽ GCP ߦᴪߞߚ⑼ቇᕈ߿୶ℂᕈ⹜ޔ 㛎ߦ߅ߌࠆ CRC ߩᓎഀ߿⽿છߥߤߦߪㅢὐ߇ᭂ Q-Pharm ߩ SC ߣ⨶ේ∛㒮ߩ CRC ߩᬺോᲧセߦ ߡᄙߩߢޔᢓ߃ߡߘߩታോ⁁ᴫࠍᲧセᬌ⸛ߒޔ 㑐ㅪߒߡޔవߕᶏᄖߣᣣᧄߩ CRC ߩᚑ┙ߦ⥋ࠆᱧ ᣣᧄߦ߅ߌࠆᴦ㛎ߩല₸ൻ߿ࠣࡠࡃ࡞ൻߦ CRC ผࠍㄡߞߡߺߚޕCRC ߪ 1970 ᐕᓟඨߦ☨࿖ߢ↢߹ ߣ߁㕙߆ࠄߤߩࠃ߁ߦ⽸₂ߢ߈ࠆ߆ࠍᬌ⸛ߔ ࠇޔએᓟ᰷⻉࿖ߦ߽᥉ߒޔቯ⌕ߔࠆߦ⥋ߞߚᣂ ࠆߎߣߣߒߚޕ ߒ⡯⒳ߢࠆޕCRC ዉએ೨ߩ⥃ᐥ⎇ⓥߢߪޔ ࿁ߩᣣᧄࠕ࠻ࠬࠝޔฦ 1 ᣉ⸳ߩ⥃ᐥ⹜㛎 ⎇ⓥߦଥࠆᬺോߩᱴߤࠍ⥃ᐥ⎇ⓥ⠪⥄り߇ⴕߞߡ ߩታᣉ⁁ᴫߩᲧセᬌ⸛ߩ⚿ᨐ߆ࠄߪᰴߩὐ߇ᜰ៰ ߚ⎇ߒ߆ߒޕⓥߩౝኈ߿ᚻ㗅߇ⶄ㔀ൻߒޔ㒮ౝ ߐࠇߚޕ ᄖߩઁㇱ⟑ߩදജ߇ᔅⷐߣߐࠇࠆߦᓥޔකᏧߦ 1㧕Q-Pharm ߦ߅ߌࠆ SC ߩ⽿ോߪ⹜㛎⽿છකᏧߩ ߣߞߡりㄭߥሽߢࠆ⋴⼔Ꮷ╬߇කᏧߩ⥃ᐥ⎇ ᓎߣߒߡ⹜㛎ߩࠦ࠺ࠖࡀ࠻߿ࡑࡀࠫࡦ ⓥࠍߔࠆࠃ߁ߦߥߞߡ߈ߚ⥄ߦ߁ࠃߩߎޕὼ⊒ ࠣࠍⴕ߁ߎߣߢࠅࠍࠇߘޔਥ⊛⢻േ⊛ߦ⥃ ↢⊛ߦ⋴⼔ᏧߦࠃࠆකᏧߩ⥃ᐥ⎇ⓥߩഥᬺോ߇ ᐥ⹜㛎ࠍⴕߞߡࠆߦࠇߘޕኻߒ⨶ޔේ∛㒮ߦ ৻⥸ൻߒߚ߇ޔߦᦝޔකቇ⊛ߥᬺോߣකቇએᄖߩᬺ ߅ߌࠆ CRC ߪ⹜㛎⽿છකᏧߩᜰ␜ਅߦᴦ㛎ߦ ോ߇ಽᜂߐࠇߚߎߣ߇ CRC ߣ߁⡯⒳ߩ↢┙ߜ දജߔࠆߣ߁ฃേ⊛ߥ┙႐ߦ⇐߹ߞߡࠆ⁁ ߣࠊࠇߡࠆ 3㧕ޕ 9/12 J Kyoritsu Univ Pharm 2007. 10 Vol. 3 47 Kobayashi A et al. ᓥߞߡ᰷⻉࿖ߢߪ CRC ࠍᴦ㛎ߦ㒢ቯߔࠆ ࡀࠫࡔࡦ࠻ߒࠦ࠺ࠖࡀ࠻ߔࠆߎߣߦࠃࠅ⹜㛎 ߎߣߥߊޔᐢߊ⥃ᐥ⎇ⓥ߿⥃ᐥ⹜㛎ߦขࠇߡࠆ ࠍṖߦㅴࠆ⡯⒳ߣℂ⸃ߐࠇࠆࠃ߁ߥ⺑ࠍߒ ࠃ߁ߢࠆޕQ-Pharm ߦ߅ߌࠆฃ⸤⹜㛎߽ᴦ㛎ߢ ߡࠆޕ࿁ߩ⺞ᩏߩ⚿ᨐߦࠃࠇ߫ޔCRC ߩᓎഀ ࠆ߆⥃ᐥ⮎ℂ⊛⎇ⓥߢࠆ߆ࠍࠊߕ CRC ߇㑐ਈ ߦ㑐ࠊࠆଏㅀߩ⻉⸥ㅀߩਛߢޔਛ㊁ࠄߩ CRC ߦ㑐 ߒߡࠆޕᣣᧄߢߪㆊߦᴦ㛎ߩߺࠍኻ⽎ߣߒߡ ߔࠆቯ⟵ߠߌ߇ Q-Pharm ߩ SC ߩ⡯ോ⸥ㅀᦠߩ⸥タ GCP ࠍዉߒߚߣ߁⚻✲߇ࠅޔᴦ㛎ࠍ⥃ᐥ⎇ ౝኈ߿ታߦᦨ߽ㄭ⨶ޕේ∛㒮ߦ߅ߌࠆ CRC ߪޔ ⓥߩ৻ㇱߢࠆߣ߁ᣇࠍߣࠄߕߦ․ᛒߒ ߘߩታᣉᬺോߩౝኈߪߎߩ⸥ㅀߦㄭ߽ߩߩޔ⡯⽿ ߡࠆᣉ⸳߇ᄙ⨶ޕේ∛㒮ߢ߽ᣂ⮎ߩᴦ㛎ߣ⥃ᐥ 㕙ߢߪਥ⊛⢻േ⊛ߦᴦ㛎ࠍࡑࡀࠫࡔࡦ࠻ߒࠦޔ ⎇ⓥ⊛ߥ⹜㛎ߣࠍߒߡขᛒߞߡ߅ࠅ⥃ޔᐥ⎇ⓥ ࠺ࠖࡀ࠻ߔࠆ┙႐ߣߒߡ⼂ߐࠇߡࠆ߆ߤ߁ ⊛ߥ⹜㛎ߦߪ CRC ߪ㑐ਈߒߡߥޕ ߆ߦߪ⇼߇ࠆޕ ᣣᧄߩᴦ㛎ߦ CRC ߇⊓႐ߒߚߩߪ 1997 ᐕߦ GCP ߎ߁ߒߚ CRC ߦ㑐ࠊࠆᓸᅱߥ⋧㆑ߪ CRC ߣ߁ ߇ቯߐࠇߡ߆ࠄߢࠆ ߒ߆ߒޕGCP ߦ㑐ࠊࠆ⻉ ⡯⒳߇ᒻᚑߐࠇࠆㆊ⒟ߩ㆑ߦ৻࿃ߒߡࠆࠃ߁ ᢥᦠߦߪᴦ㛎ࠦ࠺ࠖࡀ࠲㧔CRC㧕ߣ߁⸒⪲ ߦᕁࠊࠇࠆޔࠅ߹ߟޕ᰷ߢߪ CRC ߪකቇ⊛ౝኈ ߪߥޕGCP ⋭╙ 2 ╙ 14 㗄ߦࠃࠇ߫ CRC ߪޟᴦ એᄖߩᬺോࠍਛᔃߦข⚵ߺޔਥ⊛⢻േ⊛ߦ⹜㛎 㛎දജ⠪ߩޠ㧝ߟߣ⟎ߠߌߐࠇߩߘޔᓎഀߪ㨬ታ ታᣉࠍㆇ༡ߒޔᔅⷐߥ⺞ᢛࠍⴕ߁ߣ߁⡯⒳ߣߒߡ ᣉක≮ᯏ㑐ߦ߅ߡᴦ㛎⽿છකᏧ߹ߚߪᴦ㛎ಽᜂ ⥄ὼ⊒↢⊛ߦ⏕┙ߒߡߞߚߩߦኻߒޔᣣᧄߢߪ߹ කᏧߩᜰዉߩਅߦߎࠇࠄߩ⠪ߩᴦ㛎ߦଥࠊࠆᬺോ ߛᴦ㛎ߦ߅ߡߘ߁ߒߚ⡯⒳ࠍฃߌࠇࠆფⅣ ߦදജߔࠆ⮎Ꮷ⋴⼔Ꮷߘߩઁߩක≮㑐ଥ⠪ࠍ Ⴚ߇㉯ᚑߐࠇߥ߹߹ߦ GCP ࠍᴺൻߒߚߎߣޔ ߁㨭ߣቯ⟵ߐࠇߡࠆ⺖ߦᦝޕ㐳ㅢ⍮㧔ᐔᚑ 9 ᐕ㧕 ߘߒߡޟᴦ㛎දജ⠪ᦌ߁ߣޠᤒߥฬ⒓ߢ⹜㛎⽿છ ߢߪޟታᣉක≮ᯏ㑐ߦ߅ߡᴦ㛎ࠍታᣉߔࠆ࠴ࡓ කᏧߩᜰዉߩၮߦᴦ㛎ߦදജߔࠆࠬ࠲࠶ࡈߣ߁ ߩࡔࡦࡃߢᴦ㛎⽿છකᏧߦࠃߞߡᜰዉ⋙〈ߐࠇ ޔ⟎ߠߌߢᣣᧄߩක≮႐ߦዉߖߑࠆࠍᓧߥ ኾ㐷⊛┙႐߆ࠄᴦ㛎⽿છකᏧ߮ᴦ㛎ಽᜂකᏧߩ ߆ߞߚߡߒߘޕ⡯⢻ࠍ⋥ߔᯏળ߇ߥ߹߹ߦ ᬺോߦදജߔࠆ⠪ߢࠆޔߦᦝޕࠆߡߞߥߣޠޕ ߦ⥋ߞߡࠆ߽ߩߣ⠨߃ࠄࠇߚޕ ෘ↢⑼ቇ⎇ⓥޟᣂ GCP ᥉ቯ⌕✚ว⎇ⓥޠႎ๔ᦠ ⨶ේ∛㒮ߦ߅ߌࠆ CRC ߦ㗫ᐲ㜞ߊ↢ߓࠆᬺോߦ 㧔ᐔᚑ 9 ᐕᐲ㧕ߦߪ CRC ߪᬺോߣߒߡ⋥ޟធ⊛ߦ ߪᣉ⸳ౝߢߩㅪ⛊⺞ᢛߩ߇ࠆߚߒ߁ߎޕᬺോ ߪᴦ㛎⽿છකᏧࠍᡰេߔࠆᬺോࠍⴕ߁ޔࠅ߹ߟޕක ߇ᄙߊ⊒↢ߔࠆℂ↱ߩ㧝ߟߣߒߡޔᣣᏱ⸻≮ߩߚ ⮎ຠߩ⥃ᐥ⹜㛎ታᣉㆊ⒟ߦ߅ߡⵍߌࠊࠅߣޔ㛎⠪ ߩ⚵❱ㆇ༡ߩਛߦᴦ㛎߇⚵ࠇࠄࠇߡࠆߎ ߣᴦ㛎ߣߩ⺞ᢛࠍⴕޔᴦ㛎ߩ୶ℂᕈ⑼ޔቇᕈࠍ ߣ߇ߍࠄࠇࠃ߁ޕQ-Pharm ߢߪ⹜㛎ታᣉ↪ߦࠄ ⸽ߔࠆߚߦᵴേࠍⴕ߁⺑ߣޠߐࠇߡࠆ৻ޕᣇޔ ࠇߚ⚵❱ߩਛߢㆇ༡ߐࠇࠆߎߣ߇ߚߒ߁ߎޔㅪ⛊⺞ ਛ㊁ࠄߪ CRC ࠍޟᴦ㛎ᜂᒰකᏧᴦ㛎ଐ㗬⠪ⵍ ᢛᬺോࠍᄢߦᷫࠄߒߡࠆ㧝ߟߩᄢ߈ߥℂ↱ߣ 㛎⠪ߩ㑆ߦߞߡߡߒ࠻ࡀࠖ࠺ࠦޔᴦ㛎㧔⥃ᐥ ᕁࠊࠇࠆޕᣣᧄߩᴦ㛎ߦ߅ߡ CRC ߪᴦ㛎㐿ᆎએ ⹜㛎ߦ߹ࠇࠆ㧕߇Ṗߦㅴࠃ߁ߦᡰេߔࠆᓎഀ ೨߆ࠄ㑐ࠊࠅੌ⚳ޔႎ๔ᦠߩᚑߦ⥋ࠆ߹ߢߣ߶ޔ ࠍᜂߞߡ߅ࠅߩߘޔਥߥᡰេᬺോߪޔԘోߩ⺞ᢛ ࠎߤߩᬺോߦ㑐ߞߡࠆ৻ߩߘޕᣇޔᣣᧄߦ߅ߌࠆ ᓎޔԙⵍ㛎⠪ߩࠤࠕޔԚᴦ㛎ᜂᒰකᏧߩᡰេࠃ߅ޔ ᴦ㛎ߩᮡḰᬺോᚻ㗅ᦠ (SOP) ߦߪ㒮㐳ߣ⹜㛎⽿છ ߮ޔԛᴦ㛎ଐ㗬⠪߳ߩኻᔕߢࠆౕߣޠ⊛ߦߘߩ කᏧߩᬺോߪ⸥ߐࠇߡࠆ߽ߩߩޔSOP ߦ␜ߐࠇ ᓎഀߣᬺോౝኈࠍߍߡࠆ 4㧕5㧕 ߡࠆᬺോߩᄢඨߦ㑐ࠊࠆ CRC ߩᬺോߪ␜ߐࠇ ޕ ⸒឵߃ࠇ߫⋭ޔ GCP ߢߪ CRC ࠍޟᴦ㛎ࠍਥ ߚᢥᦠ߇ߥߩ߇⁁ߢࠆ৻ޕᣇޔQ-Pharm ߦ߅ ⊛ߦㅴࠆ⹜㛎⽿છ㧔ᜂᒰ㧕කᏧߩᜰ␜ߦᓥޔ ߡ߽ SOP ߦ SC ߩᬺോߩ⸥タߪߥ߇ޔ⡯ോ⸥ㅀ කᏧࠍᡰេߔࠆ߁ߣޠഥ⊛߆ߟฃりߩ┙႐ߣߒ ᦠߦࠃࠅᬺോߣ⽿છ߇␜ߐࠇߡࠆ߇ࠊޕ࿖ߦ߅ ߡߩ⦡ว߇ᒝ߇ޔਛ㊁ࠄߪ CRC ࠍߒࠈਥ ߡߪ Q-Pharm ߽ߡ᰷⻉࿖ߣߪ⇣ߥࠅ⋴ޔ ⊛⢻േ⊛ߥ┙႐ߢ⹜ޔ㛎⽿છ⠪ࠍߒߡ⹜㛎ࠍࡑ ⼔Ꮷ⮎ޔᏧ⥃ޔᐥᬌᩏᛛᏧߣ߁⇣ߥࠆ⍮⼂ߣᛛ 48 J Kyoritsu Univ Pharm 2007. 10 Vol. 3 10/12 原著論文 ⢻ࠍ߽ߟᛛⴚ⠪߇ CRC ࠍൕࠆ⁁ᴫߥߩߢࠇߘޔ 1㧕Q-Pharm ߢߪ SC ߪ⹜㛎⽿છකᏧߩᓎߣߒ ߙࠇߩᛛ⢻ߦᔕߓߡ⡯ോߣ⽿છࠍ⡯ോ⸥ㅀᦠߥߤ ߡਥ⊛⢻േ⊛ߦ⥃ᐥ⹜㛎ࠍࡑࡀࠫࡔࡦ࠻ߒ⹜ޔ ߢ⏕ൻߒޔ⢻േ⊛ߦ⥃ᐥ⹜㛎ࠍㅴࠆࠃ߁ߦ࿑ࠆ 㛎ߩṖߥታᣉߦദߡߚ৻ޕᣇ⨶ޔේ∛㒮ߦ ߎߣߪ߇⾰ޔ㜞ߊޔṖ߆ߟല₸⊛ߥ⥃ᐥ⹜㛎ߩታ ߅ߌࠆ CRC ߪ⹜㛎⽿છකᏧᜰ␜ਅߦᴦ㛎ߦදജ ᣉߦ❬߇ࠆߣᕁࠊࠇࠆޕ ߔࠆߣ߁ฃേ⊛ߥ┙႐ߦㄭߣᕁࠊࠇߚޕ ⹜㛎⮎ߩ⺞ߣ▤ℂ߇߭ߣࠅߩ⮎Ꮷߦછߐ 2㧕Q-Pharm ߩ SC ߣ⨶ේ∛㒮ߩ CRC ߩᬺോ߳ߩข ࠇߡࠆߣ߁ታߪ੍ᦼߖߧߎߣߢߞߚ⨶ޕේ ⚵ߺߩ㆑ߪޔ᰷☨ߢߪ⥃ᐥ⹜㛎ߦ߅ߡ⋴⼔Ꮷ ∛㒮ߢߪ⺋ᛩਈࠍ㒐ߋߚߦ⮎Ꮷߦࠃࠆ⺞ߩ ߇⹜㛎ታᣉ⠪ߩߩᓎഀࠍᜂ⥄ޔὼ⊒↢⊛ߦ ࠳ࡉ࡞࠴ࠚ࠶ࠢߪᰳ߆ߖߥޔߒ߆ߒޕQ-Pharm ߢ ⻉ᬺࠍಽᜂߔࠆߦ⥋ߞߚߩߦኻߒޔᣣᧄߢߪᴦ ߪ⺋ᛩਈࠍ㒐ߋߚߦ⮎Ꮷ߇ࠈࠈߥᎿᄦࠍ 㛎ߩⅣႺ߿߇ᢛ߁ߦవ┙ߜ GCP ߦࠃࠅ CRC ߒߡࠆ⁁ᴫ߇ⷰኤߢ߈ߚ⺋ޕᛩਈࠍߒߥߎߣ߇ ࠍޟᴦ㛎දജ⠪ߡߒߣޠ⟎ߠߌߚߣ߁ᱧผ⊛ ᒰὼߩߢࠆ⮎Ꮷߣ߁⾗ᩰ߇⍮ߐࠇߡ ⢛᥊ߦ⽶߁ߣߎࠈᄢ߈ߣ⠨߃ࠄࠇߚ࠻ࠬࠝޕ ࠆߎߣ߽ߎ߁ߒߚ◲⇛ൻࠍኈߒߡࠆ⢛᥊ߦ ࠕߢߪᱴߤߔߴߡߩ SC ߪ⋴⼔Ꮷߢߞߚ߇ޔ ࠆߩߢߪߥ߆ߣᕁࠊࠇߚޕ ᣣᧄߢߪ⋴⼔Ꮷ⮎ޔᏧ⥃ޔᐥᬌᩏᛛᏧߥߤߢ ࠆޕ ߥ߅ᧄޔႎᢥߪ⹜㛎ࠍฃ⸤ߒߡታᣉߔࠆࠝࠬ࠻ ࠕߩ 1 ᣉ⸳ߣᣣᧄߩ⨶ේ∛㒮ߣߩ⥃ᐥ⹜㛎ታ 3㧕Q-Pharm ߩ SC ߪਥߣߒߡ⹜㛎㐿ᆎએᓟߩᬺോ ᣉ⁁ᴫࠍᲧセߒߚ߽ߩߢࠆޕᓥߞߡ⺞ᧄޔᩏߩ⚿ ߦ៤ࠊߞߡࠆߦኻߒ⨶ޔේ∛㒮ߩ CRC ߩᬺോ ᨐࠍએߞߡࠝࠬ࠻ࠕోߩᴦ㛎ࠍ⺰ߕࠆߎ ߪᴦ㛎ᄾ⚂✦⚿એ೨߆ࠄᴦ㛎⚳ੌᓟߩ⋙ᩏߦ߹ ߣߦߪήℂ߇ࠆޕૉߒޔ࿁Ყセᬌ⸛ߒߚ 2 ᣉ⸳ ߢࠎߢ߅ࠅ▸ޔ࿐ߪᐢ߆ߞߚޕ ߩ⹜㛎ታᣉߩ⢛᥊߿ⅣႺߪ⇣ߥࠆߣߪ⸒߃⑼ޔቇᕈ 4㧕Q-Pharm ߢߪ SC ߦኻߔࠆ⡯ോ⸥ㅀᦠ߇↪ᗧߐ ߣ୶ℂᕈࠍᜂߒߟߟ⹜ޔ㛎ࠍല₸⊛ߦㅴࠆߣ ࠇߡ߅ࠅߩߘޔછോߣߒߡ⹜㛎⽿છකᏧࠍߒ ߁ὐߢߪෳ⠨ߣߔߴ߈ὐߪᄙߣᕁࠊࠇߚޕ ߡ⹜㛎ࠍ⥄ਥ⊛ߦࡑࡀࠫࡔࡦ࠻ߒࡦࡔࡓ࠴ޔ Q-Pharm ߪ RBH ∛㒮⟲ౝߩ 1 ⥃ᐥ⹜㛎ฃ⸤ᯏ㑐ߢ ࡃߣߩࠦ࠺ࠖࡀ࠻ߔࠆߎߣ߇⸥ߐࠇߡ ࠆ߇∛ߩߎޔ㒮⟲ߩਛߢߪᢙᄙߊߩ╙Τ㨪Φ⋧⥃ ߚޕᣣᧄߦ߅ߡ߽ CRC ߦኻߔࠆ⡯ോ⸥ㅀᦠ ᐥ⹜㛎߇ታᣉߐࠇߡ߅ࠅ࡞ࡃࡠࠣޔᴦ㛎߽ᄙߊ ࠍᚑߔࠆߎߣߪᴦ㛎ߩല₸ะߦ❬߇ࠆน⢻ ߹ࠇࠆߣᕁࠊࠇࠆޕᓥߞߡޔRBH ∛㒮⟲ౝߩࠢ ᕈ߇ࠆߣ⠨߃ࠄࠇߚޕ ࠾࠶ࠢߢ࿁ߣห᭽ߦ╙ΤޔΥ⋧⥃ᐥ⹜㛎ߩታᣉ⁁ 3. ᴦ㛎ߩࠣࡠࡃ࡞ൻߪ߹ߔ߹ߔㅴࠎߢ߅ࠅޔᣣ ᴫࠍ⺞ᩏߒޔᣣᧄߩᴦ㛎ߩታᣉ⁁ᴫߣᲧセᬌ⸛ߔࠇ ᧄߪߘߩᵹࠇߦขࠅᱷߐࠇߟߟࠆ♽⮎ޕᄢቇߦ ߫ߦᦝޔᓟߩᣣᧄߩᴦ㛎ߩല₸ൻߣࠣࡠࡃ࡞ൻ ߅ߡ⥃ᐥ⹏ଔߩቇⴚߣᢎ⢒ᵴേࠍዷ㐿ߔࠆߎ ߳ߩ␜ໂ߇ᓧࠄࠇࠆߣ⠨߃ࠆޕ ⚿⺆ 1. ࠢࠗࡦ࠭ࡦ࠼ᄢቇ㑐ㅪߩ⥃ᐥ⮎ℂ⹜㛎ฃ⸤ ᯏ㑐 Q-Pharm ߦṛߒߌ߅ߦࠕ࠻ࠬࠝޔ ࠆ⥃ᐥ⹜㛎ߩታᣉ⁁ᴫࠍⷰኤ⺞ᩏߒߚޔߚ߹ޕ ߘߩ⚿ᨐߦၮߠ߈⨶ේ∛㒮ߣ Q-Pharm ߦ߅ߌࠆ ⹜㛎ታᣉࠍ CRC 㧔ࠝࠬ࠻ࠕߢߩ⒓ߪ SC㧕 ߩⷰὐ߆ࠄᲧセߒߚޕ ౮⌀ 5 Q㧙Pharm ࠃࠅਈ߃ࠄࠇߚୃੌ⸽ 㧔╙㧝ภ㧕 2. Ყセᬌ⸛ߩ⚿ᨐ߆ࠄߪᰴߩ⻉ὐ߇ᜰ៰ߐࠇߚ㧦 11/12 J Kyoritsu Univ Pharm 2007. 10 Vol. 3 49 Kobayashi A et al. ᦨᓟߦߎߩ⎇ୃࠍᄢቇ㒮 GP ߩ৻Ⅳߣߒߡታߒ ߣߪޔᴦ㛎ߩࠣࡠࡃ࡞ൻߦᔕ߃ࠄࠇࠆੱ᧚ߩ⢒ ߡߚߛߚᦸᱜ㓉ቇ㐳ߦ߮ࠄߥޔ࿖㓙ᵹࡦ ᚑߦነਈߔࠆޕ 4. ᧄ⺞ᩏߢߪᣣᧄߩ╙Τ㨪Φ⋧⥃ᐥ⹜㛎ታᣉᣉ⸳ ࠲㐳⩲ኅ↭ሶᢎ╩ޔ߮ࠃ߅ޔ⠪ࠍฃߌࠇߡ ߣࠝࠬ࠻ࠕߩ⥃ᐥ⮎ℂ⹜㛎ታᣉᣉ⸳ߣߩ ߚߛߚ Q-Pharm ߩ Hooper ␠㐳ޔਗ߮ߦ CSDD ⹜㛎ታᣉߩ⁁ᴫࠍᲧセߒߚ߇ޔᓟޔਔ࿖ߩ╙Τ ߩ Dickinson ᚲ㐳ߦᗵ⻢ߚߒ߹ߔޕ 㨪Υ⋧⥃ᐥ⹜㛎ߩታᣉ⁁ᴫࠍᲧセߔࠆߎߣߪޔᣣ ᧄߩᴦ㛎ߩല₸ะߣࠣࡠࡃ࡞ൻߩߚߩ ᒁ↪ᢥ₂ ⋉ߥᖱႎߩឭଏߦ❬߇ࠆ߽ߩߣ⠨߃ࠄࠇࠆޕ 1㧕Tyer, J.H., Eadie, M.J., Sutherland, J.M., Hooper, ⻢ㄉ W.D., Outbreak of anticonvalsant intoxication in an Australian city. Brit. Med. J. 4, 271-273 (1970) ࿁ߩታോ⎇ୃߪ╩⠪ߦߣߞߡߪࠄࠁࠆ߽ߩ 2㧕⍹ᯅᘮᄥޔ ޟᣣᧄࠍ࿖㓙หᴦ㛎ታᣉ⁁ᴫޔޠ ╷⎇࠾ࡘࠬ No.21, 18-21 (2006) ߇ೋߡߩ㛎ߢߞߚ߇ࠍࠇߎޔᴛጊߩੱߚߜ߇ ᡰ߃ߡߊࠇߚޕQ-Pharm ߩࠬ࠲࠶ࡈߩᣇ⾰ߩ⑳ߪޘ 3㧕M-R Mueller, From delegation to specialization: ߦᔟߊ╵߃ߡߊࠇߚߒࠗ࠹ࠬࡓࡎޔవߩ nurse and clinical trial co-ordination. Nursing Monique ߣ Yoland ߥߤޔળ߁ੱߚߜߪ⊝ⷫಾߛߞ Inquiry 8: 182 – 190 (2001) ߚޕᣣᧄ⺆ࠍ⠌ᆎߡߊࠇߚࠬ࠲࠶ࡈ߽ߚޕᡷ 4㧕ޟක⮎ຠߩ⥃ᐥ⹜㛎ߣ CRCୃ⋙ޔޠ㧦㧔⽷㧕ᣣᧄ ߡᓮ␞ࠍ↳ߒߍߚޕ൩⺰ೋߡߩᵷ㆜ߛߞߚ ⮎Ꮷ⎇ୃࡦ࠲✬ޔ㓸㧦ਛ㊁㊀ⴕޔᄢᴰ੩ ߚߦᄢᄌߥߎߣߪጊߩࠃ߁ߦߞߚ߇ޔ㧝ߟ㧝ߟ ሶޔᤩ ⼱ޔ㊁ญ㓉ᔒ⮎ޔᣣႎ␠㧔2001 ᐕ㧕 ⸃ߒߡߞߚᩮᕈߣήᚒᄞਛߢㆊߏߒߚᣣߪޘ 5㧕ක≮∛㒮▤ℂ↪⺆ౖ㧔ᡷቯ╙ 3 㧕 ޔᣣᧄ∛ ᣣᧄߦዬߚࠄߒߡ⚻㛎ߔࠆߎߣߩߢ߈ߥలታ 㒮▤ℂቇળቇⴚᖱႎᆔຬળ✬ࡖࠫࠕࡆ࡞ࠛޕ ᗵߢߞߚߣ⏕ାߒߡࠆޕ ࡄࡦ㧔2006 ᐕ㧕ޕ 50 J Kyoritsu Univ Pharm 2007. 10 Vol. 3 12/12