Helmut
★★★
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Vienna, Austria,
2019-12-04 01:21
(323 d 20:35 ago)

Posting: # 20911
Views: 3,592
 

 To Russia (with love?) [RSABE / ABEL]

Dear (Russian) friends,

any ideas how/where I can get this article? The title

"PATIENTS RISK" ПРИ ПРОВЕДЕНИИ ИССЛЕДОВАНИЙ БИОЭКВИВАЛЕНТНОСТИ
ВЫСОКОВАРИАБЕЛЬНЫХ ЛЕКАРСТВЕННЫХ ПРЕПАРАТОВ
(PATIENT'S RISK IN STUDIES OF BIOEQUIVALENCE OF HIGHLY VARIABLE DRUGS)

sounds promising. I’m esp. interested in the details mentioned in the last sentence of the abstract:

Даны рекомендации по практическому применению методов коррекции инфляции ошибки I рода. (Recommendations for the practical application of methods for correcting inflation of type I error are given.)


Dif-tor heh smusma 🖖
Helmut Schütz
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Astea
★★  

Russia,
2019-12-04 07:40
(323 d 14:16 ago)

@ Helmut
Posting: # 20912
Views: 3,073
 

 To Russia (with love?)

Dear Helmut!

I'll send you a mail.

"Being in minority, even a minority of one, did not make you mad"
Helmut
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Vienna, Austria,
2019-12-04 10:58
(323 d 10:58 ago)

@ Astea
Posting: # 20914
Views: 3,054
 

 From Russia (with love?)

Hi Nastia,

» I'll send you a mail.

THX! Here the link to the PDF. Google translate gives a fair idea what is meant…

Since three authors are members of the “Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation” (and the first one is the head of the department): Are the conclusions really a recommendation? If yes, I would change the question mark of this post’s subject line to an exclamation mark. Would be the first agency – at least semi-officially – acknowledge problems with the potentially inflated type I error in reference-scaling.

Dif-tor heh smusma 🖖
Helmut Schütz
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mittyri
★★  

Russia,
2019-12-04 11:29
(323 d 10:26 ago)

(edited by mittyri on 2019-12-04 11:55)
@ Helmut
Posting: # 20917
Views: 3,024
 

 From Russia with review

Hi Helmut,

» Since three authors are members of the “Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation” (and the first one is the head of the department): Are the conclusions really a recommendation?

I would translate the sentence in the last paragraph before conclusion as:
Currently the discussions related to reference scaling modification are going on.
Conclusion says that it is just a review, not a recommendation.

Kind regards,
Mittyri
PharmCat
★    

Russia,
2019-12-04 15:16
(323 d 06:40 ago)

@ Helmut
Posting: # 20924
Views: 3,011
 

 From Russia (with love?)

Hello Helmut!

IMHO, main points:

1. Basic words. Review article.
2. ABEL/RSABE - all have TIE inflation.
3. Biggest inflation when CVintra = 25—30%.
4. EMA aproach better than FDA.

Conclusion:

When you are planning bioequivalence trial better look at EMA guidelines, rather than FDA. We know that all approaches have TIE inflation.

I think this is primarily a message to regulatory experts.
Helmut
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Vienna, Austria,
2019-12-04 17:16
(323 d 04:40 ago)

@ PharmCat
Posting: # 20926
Views: 2,997
 

 Ignorance is not bliss

Hi PharmCat,

» We know that all approaches have TIE inflation.

… and decide to ignore it cause nothing is (still!) given in the guidelines? OK, I know 1 (one!) company adjusting α in its studies.

Dif-tor heh smusma 🖖
Helmut Schütz
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nobody
nothing

2019-12-04 18:12
(323 d 03:44 ago)

@ Helmut
Posting: # 20927
Views: 2,964
 

 Ignorance is not bliss

We all know for sure for decades:

War Is Peace, Freedom Is Slavery, Ignorance Is Strength

No way around that...

Kindest regards, nobody
PharmCat
★    

Russia,
2019-12-04 18:12
(323 d 03:43 ago)

@ Helmut
Posting: # 20928
Views: 2,975
 

 Ignorance is not bliss - but this is modus vivendi

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.
Astea
★★  

Russia,
2019-12-04 18:15
(323 d 03:41 ago)

@ Helmut
Posting: # 20929
Views: 2,964
 

 Ignorance is Strength?

Dear Helmut and friends!

The aim of that article was to give an idea to Russian-speaking people about what is going considering TIE in reference-scaled approaches. It is just a review article and not a regulatory document.

There is still a lot of misunderstanding right up to simplifing all as "don't use ABEL/RSABE". This article is an attempt to look deeper to the problem. The more profound reader should refer to the source articles.

I could be wrong but I think Russian experts would be afraid to claim any official position on dealing with TIE inflation before it would be stated in any European country.

"Being in minority, even a minority of one, did not make you mad"
Helmut
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Vienna, Austria,
2019-12-04 19:15
(323 d 02:41 ago)

@ Astea
Posting: # 20930
Views: 2,946
 

 So sad!

Hi Nastia,

» […] I think Russian experts would be afraid to claim any official position on dealing with TIE inflation before it would be stated in any European country.

weltschmerz
(n.) lit. “world-pain”; the state of sadness and
depression felt when the world as it is doesn’t
reflect what you think it should be

GERMAN


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Helmut Schütz
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PharmCat
★    

Russia,
2019-12-05 11:09
(322 d 10:47 ago)

@ Astea
Posting: # 20931
Views: 2,876
 

 does existence exist?

» I could be wrong but I think Russian experts would be afraid to claim any official position on dealing with TIE inflation before it would be stated in any European country.

Hello Astea!

You see the root in this matter. But we can ask next question: why officials afraid to claim any point of view? And then next: is this point exist?
Helmut
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Vienna, Austria,
2019-12-06 10:37
(321 d 11:19 ago)

@ PharmCat
Posting: # 20936
Views: 2,777
 

 OT: Something and nothing

Hi PharmCat,

I like your subject line.
A rather philosophical question starting with Parmenides’ “Why is something and not nothing?”
If you want to get a headache I suggest Martin Heidegger’s [image] Being and Time. Even the German original is practically incomprehensible.

Dif-tor heh smusma 🖖
Helmut Schütz
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Astea
★★  

Russia,
2019-12-06 11:52
(321 d 10:04 ago)

@ Helmut
Posting: # 20938
Views: 2,777
 

 add OT: Everything and Nothing

Hello PharmCat and Helmut!

PharmCat, you adress too philosophic question, it's impossible to find a material answer on it.

» If you want to get a headache I suggest Martin Heidegger’s

Deutch philosophers are cool!
You may also turn to Pelevin's "Crystal World" for the subject of surreal world as well :cool:

"Being in minority, even a minority of one, did not make you mad"
mittyri
★★  

Russia,
2019-12-06 12:04
(321 d 09:52 ago)

@ Helmut
Posting: # 20939
Views: 2,764
 

 OT: Something and nothing Russian edition

Hi Helmut,

» If you want to get a headache I suggest Martin Heidegger’s [image] Being and Time. Even the German original is practically incomprehensible.

Well, for Russians I would recommend Bibikhin, he's a famous researcher and translator of Heidegger's papers.
Does not prevent headache, but not related to the language gap.
Don't know German traditions, but here in Russia it is well known that such papers should be studied after some :party::-D

Kind regards,
Mittyri
nobody
nothing

2019-12-06 21:33
(321 d 00:22 ago)

@ mittyri
Posting: # 20951
Views: 2,718
 

 OT: Something and nothing Russian edition

...only thing on Heidegger I would recommend:

https://www.youtube.com/watch?v=7dtawhoZv1w

Kindest regards, nobody
Helmut
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Vienna, Austria,
2019-12-07 20:11
(320 d 01:44 ago)

@ nobody
Posting: # 20956
Views: 2,677
 

 OT: “Deutscher Humor”

N’Abend!

Was wieder einmal zeigt: “Deutscher Humor” ist ein Widerspruch in sich selbst. :-|

Dif-tor heh smusma 🖖
Helmut Schütz
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nobody
nothing

2019-12-07 20:30
(320 d 01:25 ago)

@ Helmut
Posting: # 20957
Views: 2,688
 

 OT: “Deutscher Humor”

....jjjjjiiiiaaaaaaa, ... aber nein.

Kindest regards, nobody
Helmut
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Vienna, Austria,
2019-12-07 20:42
(320 d 01:14 ago)

@ nobody
Posting: # 20958
Views: 2,681
 

 OT: “Deutscher Humor”

N’Abend!

» ....jjjjjiiiiaaaaaaa, ... aber nein.

T’schuidig’n! Familiär vorbelastet (mit einer Gewinnerin des [image] Deutschen [sic] Klein­kunstpreises verheiratet). Kritisch und so.

Dif-tor heh smusma 🖖
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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nobody
nothing

2019-12-07 21:21
(320 d 00:35 ago)

@ Helmut
Posting: # 20960
Views: 2,684
 

 OT: “Deutscher Humor”

Lisa Eckhart? Glückwunsch! :-D

Ick korrigiere, ich denke, ich habe die richtige Dame gefunden. Das Hobby hat sie verraten...

Kindest regards, nobody
PharmCat
★    

Russia,
2019-12-06 23:26
(320 d 22:30 ago)

@ Helmut
Posting: # 20953
Views: 2,733
 

 OT: Something and nothing

» If you want to get a headache I suggest Martin Heidegger’s [image] Being and Time. Even the German original is practically incomprehensible.

Thank you, Helmut!

It would be great if the singularity has already been discovered by then. :lol:

Hi, Astea!

» You may also turn to Pelevin's "Crystal World" for the subject of surreal world as well :cool:

I saw the translation of "Empire V: The Prince of Hamlet" and "S.N.U.F.F." by Victor Pelevin. Unfortunately "Sacred view on Fuji" not already translated.
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