Vaibhav Patil ☆ India, 2022-07-29 09:20 (864 d 08:59 ago) Posting: # 23187 Views: 3,326 |
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For modifed release formulation (Bioequivalence of partial AUC), refer the article link https://link.springer.com/article/10.1208/s12248-012-9396-8 This elaborates: Which part of the curve bioequivalence needs to be established, upper or lower? Is it acceptable approach for EU submission. |
Helmut ★★★ Vienna, Austria, 2022-07-29 13:04 (864 d 05:15 ago) @ Vaibhav Patil Posting: # 23188 Views: 2,771 |
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Hi Vaibhav, ❝ For modifed release formulation (Bioequivalence of partial AUC) […] ❝ Comparisons of HaVD and MDT can be evaluated by nonparametric calculations ❝ Which part of the curve bioequivalence needs to be established, upper or lower? ❝ Is it acceptable approach for EU submission. Since you posted in the category Regulatives / Guidelines and asked specifically for a European submission:
The calculation of MDT is trivial. However, if there are multiple peaks, MDT is undefined. Only formerly in Russia and currently in Kazakhstan yet another metric, the ‘Plateau Time’2 t75% (aka Peak Occupancy Time 75 ‘POT-75’) was/is required.3 PS: Why did you upload the figure seven times in the lousy JPG-format (see there)? I removed them and uploaded an 8 bit PNG including the legend instead. PPS: A salutation in posts is polite and never hurts.
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
mittyri ★★ Russia, 2022-07-30 16:17 (863 d 02:03 ago) @ Helmut Posting: # 23193 Views: 2,676 |
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Hi Helmut, ❝ Only formerly in Russia and currently in Kazakhstan yet another metric, the ‘Plateau Time’2 t75% (aka Peak Occupancy Time 75 ‘POT-75’) was/is required.3 ❝ <...> ❝ 3. Shohin IE, Roshdestvenskij DA, Medvedev VYu, Komarow TN, Grebenkin DYu. Russia, Belarus & Kasakhstan. In: Kanfer I. (ed). Bioequivalence Requirements in Various Global Jurisdictions. Cham: Springer; 2017. pp. 199–227. Sorry, I don't have that book to prove my opinion, but I strongly doubt that it is still applicable in Kasakhstan as a member of EEU. Appendix X for Regulations conducting BE studies within the framework of the EEU approved 2 years ago is related to modified release forms and it mimics (what a surprise!) EMA MR Guide. I see that related to Kazakhstan links provided on the book site are pretty old. — Kind regards, Mittyri |
Helmut ★★★ Vienna, Austria, 2022-08-01 20:44 (860 d 21:35 ago) @ mittyri Posting: # 23199 Views: 2,620 |
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Hi mittyri, ❝ […] I strongly doubt that it is still applicable in Kasakhstan as a member of EEU. I trust you, of course. ❝ Appendix X for Regulations conducting BE studies within the framework of the EEU… Do you have a copy? The site times out, regardless which browser I tried. Not even the TOR-browser with the Snowflake-plugin via a VPN worked. Is the site really down or access blocked? The webarchive didn’t work either. The last capture is poo. ❝ approved 2 years ago is related to modified release forms and it mimics (what a surprise!) EMA MR Guide. ❝ I see that related to Kazakhstan links provided on the book site are pretty old. Right. I had to work with what I have. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
mittyri ★★ Russia, 2022-08-01 23:24 (860 d 18:55 ago) @ Helmut Posting: # 23200 Views: 2,683 |
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Hi Helmut, ❝ ❝ Appendix X for Regulations conducting BE studies within the framework of the EEU… ❝ ❝ Do you have a copy? The site times out, regardless which browser I tried. Not even the TOR-browser with the Snowflake-plugin via a VPN worked. Is the site really down or access blocked? ❝ The webarchive didn’t work either. The last capture is poo. sorry, that link was a real nightmare, seems like it is not a simple html. On EEU site there is a pdf on Russian with the list of changes. Since Appendix 10 was introduced primarily, it could be treated as is. I've found it here, where also a zip archive could be found with a Word version of the document. — Kind regards, Mittyri |