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【求助】藥物臨床Ia期是什么意思?求詳解
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| 臨床試驗中的Ia,Ib,Ic表示什么意思呢?是不是每期臨床都有這樣的劃分嗎? |
藥物臨床試驗精華帖 |
» 搶金幣啦!回帖就可以得到:
+5/300
+1/98
+1/96
+1/90
+1/86
+1/84
+1/62
+1/53
+1/47
+1/38
+1/19
+1/16
+1/7
+2/6
+1/4
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+1/3
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+1/1
+1/1
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Phase II Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups (20-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects. Phase II studies are sometimes divided into Phase IIA and Phase IIB. * Phase IIA is specifically designed to assess dosing requirements (how much drug should be given). * Phase IIB is specifically designed to study efficacy (how well the drug works at the prescribed dose(s)). Some trials combine Phase I and Phase II, and test both efficacy and toxicity. Trial design Some Phase II trials are designed as case series, demonstrating a drug's safety and activity in a selected group of patients. Other Phase II trials are designed as randomized clinical trials, where some patients receive the drug/device and others receive placebo/standard treatment. Randomized Phase II trials have far fewer patients than randomized Phase III trials. |
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翻譯成了中文版,你可以借鑒一下,不一定準確,參考吧。 二期臨床 一旦研究藥物的初期安全性在第一階段被證實了,二期臨床需要對更大的數量(20-300)進行驗證,評估藥物如何發(fā)揮作用,更多的志愿者和病人參與以進一步評估一期臨床的安全性。一種新藥的研發(fā)過程失敗往往發(fā)生在二期臨床,此時發(fā)現藥物沒有按照計劃起作用,或者具有毒性。 二期臨床研究通常分為a和b兩個階段 a用于評估劑量要求(應該用藥多少) b用于評估藥效(特定劑量時藥物如何發(fā)揮作用) 一些試驗有一期和二期組成,檢驗有效性和毒性 試驗設計: 部分二期臨床的目的是證明藥物的安全性和對選定的病人的活性。其他的是隨機臨床試驗,一部分病人接受藥物/醫(yī)療器械和另一部分對照品/標準品治療。隨機二期臨床試驗比隨機三期臨床病人少很多。 |
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