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quann
@quan1010.bsky.social
男人至死是高中生
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March 10, 2025 at 7:12 AM
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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。
February 16, 2025 at 12:53 AM
Shouts from Everton fans for a handball on Ibrahima Konate — the referee waved it away.

#EVELIV | #EFC | #LFC
February 12, 2025 at 9:09 PM
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Yes
February 10, 2025 at 4:33 AM
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Guess what he was trying to say? 🥹🤩

#cat #catlover #pet
December 13, 2024 at 1:16 PM
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I wish I could adopt every stray cat ❤️

#cat #catlover #pet
December 12, 2024 at 6:49 PM
December 13, 2024 at 12:03 PM
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風景イラスト
「時の駅」
December 10, 2024 at 11:27 AM
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kanto starters 👾
#art #pokemon #pokemonfanart
December 10, 2024 at 5:05 AM
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sakura mako 🦈
🌸 #art #sharks
December 7, 2024 at 3:01 AM
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November 29, 2024 at 12:30 PM
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shark vending machine
🦈 #art #sharks
November 26, 2024 at 1:45 AM
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November 22, 2024 at 12:28 PM
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That cant be right
🦈 #art #sharks #comics
November 19, 2024 at 11:57 PM
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November 16, 2024 at 8:23 AM
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bulbasaur 🌱 #art #pokefanart
November 16, 2024 at 2:53 AM
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Oh to be a shark
November 11, 2024 at 11:27 PM
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Good morning lovely people! How are ya :0
November 5, 2024 at 1:52 PM
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smoll shark
November 4, 2024 at 1:42 AM
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トレーサー
November 3, 2024 at 7:53 AM
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good night
November 2, 2024 at 7:25 AM
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November 2, 2024 at 9:06 PM
good day
November 2, 2024 at 4:57 PM
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supportive sharks 🦈💙
November 1, 2024 at 2:31 AM
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October 30, 2024 at 4:49 AM