Human Pharmacology Studies

Timing of human pharmacology studies

씤泥댁빟由ъ떆뿕 떊빟 媛쒕컻 以 쓽빟뭹怨 씤泥 媛꾩쓽 긽샇옉슜뿉 븳 湲곗큹쟻씤 젙蹂대 뼸뒗 엫긽떆뿕엯땲떎.
쐞 洹몃┝뿉 젣떆븳 寃껋쿂읆 떎뼇븳 醫낅쪟쓽 엫긽떆뿕씠 뿬湲곗뿉 룷븿릺硫, 꽌슱꽦紐⑤퀝썝 엫긽빟由ш낵뒗 씠윭븳 紐⑤뱺 醫낅쪟쓽 씤泥댁빟由ъ떆뿕쓣 닔뻾븷 닔 엳뒗 뒫젰쓣 솗蹂댄븯怨 엳뒿땲떎. 씠 以 씤泥댁뿉꽌쓽 媛쒕뀗 利앸챸(Proof-of-Concept, PoC)쓣 쐞븳 2긽 엫긽떆뿕(Therapeutic exploratory studies)쓣 꽕怨꾪븯湲 쐞빐 븘닔쟻쑝濡 슂援щ릺뒗 떒쉶 삉뒗 諛섎났 닾뿬 엫긽떆뿕, 嫄닿컯씤/솚옄 긽 빟룞빟젰븰 떆뿕 벑쓣 1긽 엫긽떆뿕씠씪怨 遺꾨━븯뿬 吏移븯뒗 寃쎌슦媛 留롮쑝硫, 씠윭븳 떆뿕뱾 留ㅼ슦 떊냽븯寃 닔뻾릺뼱빞 븯誘濡 씗 遺꽌뿉꽌뒗 씠瑜 쐞빐 긽옄 紐⑥쭛, 엫긽 쟾臾멸 怨듬룞 뿰援, DSMB 援ъ꽦 諛 怨듬룞 IRB 떖궗 벑怨 愿젴븳 泥닿퀎瑜 援ъ텞븯뒿땲떎.

씠윭븳 떊빟 媛쒕컻 봽濡쒖꽭뒪 씠쇅뿉룄 깮臾쇳븰쟻룞벑꽦떆뿕, 媛쒕웾떊빟쓽 鍮꾧탳빟룞븰떆뿕 벑 떎뼇븳 뿀媛슜 떆뿕쓣 닔뻾븷 닔 엳뒿땲떎.
듅엳, 理쒓렐 쟾엫긽~2긽쓽 吏꾪뻾 냽룄瑜 넂뿬 떊빟 媛쒕컻쓽 슚쑉꽦怨 깮궛꽦쓣 젣怨좏븯怨좎옄 븯뒗 듃젋뱶뿉 뵲씪 泥⑤떒 怨좊궃씠룄 엫긽떆뿕 꽕怨 諛 닔뻾씠 媛뒫빀땲떎.

씤泥댁빟由ъ떆뿕 닔뻾怨 愿젴븳 꽌鍮꾩뒪 빆紐⑸뱾 븘옒 媛숈뒿땲떎.

쨌 슜웾援 꽕젙, 梨꾪삁 룷씤듃 꽕젙, 긽옄 닔 궛異 벑 엫긽떆뿕 꽕怨
쨌 엫긽떆뿕怨꾪쉷꽌, 利앸湲곕줉꽌, 긽옄 꽕紐낅Ц 諛 룞쓽꽌 벑 湲곕낯 臾몄꽌 옉꽦
쨌 IRB 떖궗 젒닔 諛 듅씤 궗빆 愿由 벑 뾽臾
쨌 쟻쓳利 蹂 빐떦 吏꾨즺怨 怨듬룞뿰援ъ옄 留ㅼ묶 諛 옄臾 솗蹂
쨌 엫긽떆뿕 떎臾 - 긽옄 諛⑸Ц, 닾빟 諛 寃泥 솗蹂, 븞쟾꽦 룊媛, 寃泥 愿由 諛 蹂닿
쨌 엫긽떆뿕 寃泥 遺꾩꽍 - LC/MS/MS瑜 씠슜븳 빟룞븰 寃泥 遺꾩꽍 諛 뿰援ъ냼 뿰怨 빟젰븰 寃泥 遺꾩꽍
쨌 빟룞빟젰븰 寃곌낵 遺꾩꽍 諛 옄臾
쨌 엫긽떆뿕 넻怨 遺꾩꽍 諛 寃곌낵蹂닿퀬꽌 옉꽦
쨌 솚옄 긽 씤泥댁빟由ъ떆뿕 寃泥 愿젴 꽌鍮꾩뒪 諛 빟룞빟젰븰 옄臾 뾽臾