Scholar

Yisu Zhou

H-index: 17
Education 43%
Engineering 32%

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一致性评价是确保仿制药有效、安全的关键监管措施。然而,若仿制药在通过一致性评价后,生产环节发生变化,是否依旧符合与参比试剂的一致性?

实际上,一款仿制药在通过一致性评价后,可对原材料供应商、生产工艺、生产厂址等多项生产环节进行变更,而无需重新进行一致性评价,多数情况只需在省级药监部门进行备案。

我分析了国家药监局公布的2019年至今的16万余条药物补充备案,发现通过一致性评价的仿制药、进入集采的药品中,广泛存在过评后生产环节的变更。

并且,进入集采的药品,相对于同成分但未进入集采的药品,进行了更多此类变更。

这些变更并非一定会影响药效、安全性,但仍需解决如何对此进行有效监管的问题。

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"Nine Thoughts We've All Had in Burawoy's Class"
A classmate posted this in 2015, when we were taking Soc 101 with Michael Burawoy.
No. 9: "Theory is hard. Thank god we have Burawoy."
As a resident of Macau, Adelson’s move stunned the local community last year for brining Mavs to a preseason game in 2025. Now we only get AD.
Open to hearing about any conspiracy involving the Adelsons.

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Open to hearing about any conspiracy involving the Adelsons.

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Year of the snake welcomed in Shanghai in 1941. Certainly not the best year for British and Americans In the city.
To me, the New Year always mixes celebration with the living and remembrance of those who have passed. It’s a reminder that family dynamics are an enduring source of life experience for the Chinese.
mp.weixin.qq.com/s/jK7teXkBhp... An interesting interview with Wan Gang (China's Minister of S&T from 2007 to 2018, key figure in China's EV push) and Oliver Blume (Volkswagen CEO). They've known each other since the 90s; Blume was supervised by Wan for his PhD. Full of historical details.
《时代周刊》对话中国“新能源汽车之父”克大校友万钢与大众集团CEO Oliver Blume博士
mp.weixin.qq.com
笔耕不辍,退休前还在做研究。
Finally received the book over the weekend. It's a page-turner and a great read!

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Join us for Yingyao Wang’s book talk next Friday EST.
Zoom ID: 852 364 4345
Passcode: sociology

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Today's words of wisdom from Spurs practice
第一次来宁诺诺丁汉,中国第一所中外合作办学大学,今年正好20岁。

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INLAND EMPIRE - Why should we just leave and leave -- and the world get left behind?
和推特不一样,蓝天上大部分都是中文或者研究中国的学者
Looking for good Chinese feeds / communities
想知道Bluesky有啥有趣的中文社群

Reposted by Yisu Zhou

Looking for good Chinese feeds / communities
想知道Bluesky有啥有趣的中文社群
This morning, I’m reading Alice Amsden—every developing state seems to have gone through a similar process.
I recall a heated debate in Dushu after its release in 2005, focused mainly on labor abuses and class issues, with little attention to the developmental aspect. Could this stage of brutal manufacturing have been shortened? Were there real alternatives?
Factory workers being treated like consumables resonated deeply with her. The idea that reform amounted to class betrayal of rural families struck her hard. Twenty years later, this work still hits just as hard. But of course, the optics of the book have shifted dramatically over time.
In my reading group with grad students yesterday, the theme was “factory.” One student chose Pun Ngai’s Made in China. Unfamiliar with this scholarship before, she said reading it made her extremely sad, as she comes from a rural family herself.
Spent an afternoon with a realist historian of international relations. Lots of insights and chilling claims. We’re working on a similar project. One line left a strong impression on me: “We are back to the age of hard power competition. Head-to-head.”

References

Fields & subjects

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