学习CDER如何推进监管科学以保护公众健康

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Learn how CDER is advancing regulatory science to protect public health.
学习 CDER如何推进监管科学以保护公众健康

CDER Researchers – In Their Own Words
CDER研究者 – 用他们自己的话说

CDER的监管科学-来自Dr. Madabushi , Ph.D. 的播客

CDER的监管科学Madabushi博士
来自药品注册英语学习平台微信


Dr. Madabushi: I’ve been here close to around 11 years. I cannot think of another place to go and work. Given the variety of problems I get to see, the different types of solutions that people apply and different disciplines, how they come together, it’s just like a team sport.
我在这里将近11年了。我想不出另一个地方去工作。考虑到我所看到的各种问题，人们应用的不同类型的解决方案和不同的学科，它们是如何组合在一起的，就像团队运动一样。

Raj Madabushi, Ph.D.
Team Leader 组长
Guidance and Policy Team 指南和政策办公室
Office of Translational Sciences 转化科学办公室
Office of Clinical Pharmacology 临床药理学办公室

Dr. Madabushi: I see almost on a daily level the Office of Clinical Pharmacology routinely applying model-informed drug development approaches not only in trying to better understand the diseases and provide solutions for them, but also to help the drug development programs, as well as inform the drug labeling for getting the right dose for the right patient at the right time.
我几乎每天都能看到临床药理学办公室日常应用模式-知情的药物开发方法, 不仅是为了更好地了解疾病, 并为他们提供解决方案, 而且还帮助药物开发项目,以及告知药物标签, 以便合适的病人在恰当的时间使用正确的剂量。

Model-informed drug development is an approach, which uses mathematical modeling of data from drugs, especially the information on efficacy and safety from studies in animals as well as humans to improve the drug development and decision making.
模型知情药物开发是一种方法，它使用药物的数学模型，特别是从动物和人类的研究中获得的有效性和安全性信息，以改进药物的开发和决策。

We all know that while drugs are developed generally with one dose for all. So, the effect of the body on how it processes the drugs and thereby resulting in differential drug levels can be modeled and we can then provide dosing instructions for these different subpopulations.
我们都知道，虽然药物的开发一般是一剂全剂量。因此人体如何处理药物与由此导致的不同药物水平的影响可以被建模。然后我们可以为这些不同的亚群提供剂量指示。

One of the exciting areas in the Office of Clinical Pharmacology are pediatric drug development programs.
临床药理学办公室一个令人兴奋的领域是儿科药物开发项目。

Even in children as they’re growing, there is maturation and organs are developing. Mathematical models account for these to try to help inform what might be the right dose for children and different age groups of children.
即使在孩子成长的时候, 也存在成熟过程和器官发展。数学模型解释了这些, 试图帮助告知什么可能是儿童正确的剂量和不同年龄的儿童群体。

Information is in the form of numbers. That’s our understanding, and how can we leverage and add them as layers from one stage to another stage. So that we can provide contemporary guidances with the evolving knowledge that comes from the application of all this information so that we can have guidances that are most proximately related to all the learnings and applications that we are having, so that these become routine as we go forward and as we are encountering newer challenges and newer solutions.
信息以数字的形式存在。这就是我们的理解，我们怎样才能把它们作为层从一个阶段扩展到另一个阶段呢？我们可以提供当代指南与来自所有这些信息的应用而不断发展的知识。所以，我们所拥有的指南与我们所拥有的学问和应用有极其近似的联系。因此，这成为我们前行和遭遇更新的挑战和解决方案的日常。


日积月累

close to 离…近; 与…关系密切
types of 各种类型的
disciplines 学科
Clinical Pharmacology 临床药理学
routinely 例行公事地; 常规地
drug development 药物开发
labeling 标贴，标志
dose 剂量，药量
at the right time 在适当时候`
mathematical 数学的
efficacy 功效
decision making 决策，判定
differential 差别的; 特意的
modeled 模型化的
maturation 成熟
organs 器官;
Mathematical models 数学模型
account for 说明; 导致
inform 通知
leverage 杠杆作用; 影响力
evolving 演变，进化
proximately 近似地
go forward 前进; 发生; 被提出
encounter 遭遇; 遇到

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