Plateau Time in Kazakhstan? [Regulatives / Guidelines]

posted by mittyri – Russia, 2022-07-30 16:17 (570 d 11:09 ago) – Posting: # 23193
Views: 1,536

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,

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