Plateau Time in Kazakhstan? [Regulatives / Guidelines]

posted by mittyri – Russia, 2022-07-30 16:17 (238 d 05:25 ago) – Posting: # 23193
Views: 981

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,

Complete thread:

UA Flag
 Admin contact
22,551 posts in 4,724 threads, 1,606 registered users;
10 visitors (0 registered, 10 guests [including 4 identified bots]).
Forum time: 20:42 CET (Europe/Vienna)

If there is an exception to any rule,
and if it can be proved by observation,
that rule is wrong.    Richard Feynman

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz