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RegisterPlateau Time in Kazakhstan? [Regulatives / Guidelines]
Hi Helmut,
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.
❝ 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
Kind regards,
Mittyri
Complete thread:
- Partial AUC Vaibhav Patil 2022-07-29 07:20
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- H[a]VD and MDT Helmut 2022-07-29 11:04
- Plateau Time in Kazakhstan?mittyri 2022-07-30 14:17
- Plateau Time in Kazakhstan? Helmut 2022-08-01 18:44
- EEU changes came into force 11.03.2021 mittyri 2022-08-01 21:24
- Plateau Time in Kazakhstan? Helmut 2022-08-01 18:44
- Plateau Time in Kazakhstan?mittyri 2022-07-30 14:17
- H[a]VD and MDT Helmut 2022-07-29 11:04
Ing. Helmut Schütz