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RegisterIgnorance is not bliss - but this is modus vivendi [RSABE / ABEL]
Hi Helmut,
» … and decide to ignore it cause nothing is (still!) given in the guidelines? OK, I know 1 (one!) company adjusting α in its studies.
This is the rhetorical question. 😺 So... Throughout the existence of the “Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation” I don't remember any "inhouse" guidline for bioequivalence. Just retelling EMA/FDA guidlines. From other side, officials don't like to include experts for guideline development and don't have any discussions - this does not apply to meetings of the Euro-Asian Economic Union, the situation is reversed there, but the tasks of developing EEU guidlines are completely different at this moment. So, we don't have any actors at this time who could manage any new guideline development.
And this article and similar we can be seen as "guideline" for understanding - as expert-officials think.
» … and decide to ignore it cause nothing is (still!) given in the guidelines? OK, I know 1 (one!) company adjusting α in its studies.
This is the rhetorical question. 😺 So... Throughout the existence of the “Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation” I don't remember any "inhouse" guidline for bioequivalence. Just retelling EMA/FDA guidlines. From other side, officials don't like to include experts for guideline development and don't have any discussions - this does not apply to meetings of the Euro-Asian Economic Union, the situation is reversed there, but the tasks of developing EEU guidlines are completely different at this moment. So, we don't have any actors at this time who could manage any new guideline development.
And this article and similar we can be seen as "guideline" for understanding - as expert-officials think.
Complete thread:
- To Russia (with love?) Helmut 2019-12-04 01:21 [RSABE / ABEL]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- To Russia (with love?) Astea 2019-12-04 07:40
- From Russia (with love?) Helmut 2019-12-04 10:58
- From Russia with review mittyri 2019-12-04 11:29
- From Russia (with love?) PharmCat 2019-12-04 15:16
- Ignorance is not bliss Helmut 2019-12-04 17:16
- Ignorance is not bliss nobody 2019-12-04 18:12
- Ignorance is not bliss - but this is modus vivendiPharmCat 2019-12-04 18:12
- IGNORANCE IS STRENGTH? Astea 2019-12-04 18:15
- So sad! Helmut 2019-12-04 19:15
- does existence exist? PharmCat 2019-12-05 11:09
- Ignorance is not bliss Helmut 2019-12-04 17:16
- From Russia (with love?) Helmut 2019-12-04 10:58
- To Russia (with love?) Astea 2019-12-04 07:40
Ing. Helmut Schütz