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小木虫论坛-学术科研互动平台 » 生物医药区 » 新药研发 » 临床研究 » 【求助】药物临床Ia期是什么意思?求详解
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smy05106111

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[交流] 【求助】药物临床Ia期是什么意思?求详解

临床试验中的Ia，Ib，Ic表示什么意思呢？是不是每期临床都有这样的划分吗？
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1楼 2010-12-01 15:09:11
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wx825061

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4楼: Originally posted by 鸭绿江畔 at 2010-12-08 13:58:30
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, ...

原文是来源于哪里的呢？什么文件？想仔细学习一下。谢谢。
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9楼2019-03-04 10:56:50
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ronalbeck

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warlen(金币+1):谢谢参与 2010-12-02 09:17:05
smy05106111(金币+2): 2010-12-08 15:48:35
I期临床试验方案应包括依次进行的三部分，即单次给药耐受性试验方案、单次给药药代动力学试验方案、连续给药药代动力学试验方案。
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2楼2010-12-02 09:08:32
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smy05106111

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那二期呢

引用回帖:
Originally posted by ronalbeck at 2010-12-02 09:08:32:
I期临床试验方案应包括依次进行的三部分，即单次给药耐受性试验方案、单次给药药代动力学试验方案、连续给药药代动力学试验方案。

那么二期临床的a，b，c又代表什么意思呢
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3楼2010-12-02 20:21:52
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鸭绿江畔

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smy05106111(金币+3): 2010-12-08 15:48:43
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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4楼2010-12-08 13:58:30
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