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mittyri ★★ Russia, 2019-04-02 14:32 (2232 d 07:27 ago) Posting: # 20111 Views: 4,878 |
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Dear Colleagues! I'm looking into April Fools' Day joke by EMA. Could some of you shade more light regarding that? Are there any scientific papers where lack of bioequivalence was demonstrated due to absence of PK Solidarity? Eagerly waiting for 'modified Wagner-Nelson method, the details of which will be added to the Q&A on the website'. — Kind regards, Mittyri |
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nobody nothing 2019-04-02 14:39 (2232 d 07:20 ago) @ mittyri Posting: # 20112 Views: 4,081 |
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...don't invest too much time, from 01-OCT-2021 EMA will accept BE only based on portal vein concentrations of drugs. — Kindest regards, nobody |
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Helmut ★★★   Vienna, Austria, 2019-04-02 15:00 (2232 d 06:59 ago) @ nobody Posting: # 20113 Views: 4,031 |
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Furthermore, the EMA is considering the FDA’s definition as laid down in CFR21§320.23(a)(1) for locally acting drugs […] scientifically valid measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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nobody nothing 2019-04-02 15:37 (2232 d 06:22 ago) @ Helmut Posting: # 20114 Views: 4,103 |
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— Kindest regards, nobody |
Ing. Helmut Schütz