PreClinical Flashcards

1
Q

非临床研究主要包括哪三个方面

A

药理,药代,毒理

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2
Q

药代部分主要包括什么

A

ADME以及药物药物相互作用

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3
Q

药理学主要包括什么

A

主要药效学
次要药效学
安全药理
药效学药物相互作用

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4
Q

非临床试验的主要目的是

A

为临床实验的安全性进行评估

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5
Q

毒理包括哪些

A
单次给药毒性
重复给药毒性
遗传毒
致癌毒
生殖和发育毒性
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6
Q

毒代的作用是什么

A

用来解释毒理学的发现

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7
Q

重复给药毒性实验的周期由什么决定

A

临床实验的周期

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8
Q

ADA的研究包括哪三步

A

1 Screen Assay
2 Confirmation Assay
3 Characterization Assay

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9
Q

简单的PK Assay通常的设计是什么样的

A

Non-competitive Assay

  1. mAb铺板
  2. 加血浆孵育,洗板
  3. 加二抗anti-antibody labelled with enzyme,孵育洗板
  4. 加底物,孵育,测量可见光
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10
Q

ELISA实验中所谓的质控QC样品指的是什么?作用是干嘛

A

用拉标曲的标准品额外制备的高中低三个样品

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11
Q

ADA 和PK assay 主要区别在于

A

ADA assay 中样品的antibodies一头接着coated mAb,一头接着labelled mAb

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12
Q

ADA研究中的screening Assay 和 confirmation assay 在方法上有什么区别

A

Screening assay 用non-competitive ELISA

Confirmation assay 用 competitive ELISA

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13
Q

简单的PK Assay通常的设计是什么样的

A

Non-competitive Assay

  1. mAb铺板
  2. 加血浆孵育,洗板
  3. 加二抗anti-antibody labelled with enzyme,孵育洗板
  4. 加底物,孵育,测量可见光
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14
Q

ELISA实验中所谓的质控QC样品指的是什么?作用是干嘛

A

用拉标曲的标准品额外制备的高中低三个样品

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15
Q

ADA 和PK assay 主要区别在于

A

ADA assay 中样品的antibodies一头接着coated mAb,一头接着labelled mAb

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16
Q

ADA研究中的screening Assay 和 confirmation assay 在方法上有什么区别

A

Screening assay 用non-competitive ELISA

Confirmation assay 用 competitive ELISA

17
Q

IC50 EC50定义

A

EC50: Half maximal effective concentration

IC50: Half maximal inhibited concentration

18
Q

非临床安全性评价的工作包括

A
通常的毒理实验:急毒,长毒
生殖毒性
基因毒性
ADME
毒代