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Helmut ★★★   Vienna, Austria, 2019-12-04 02:21 (1827 d 23:17 ago) Posting: # 20911 Views: 10,675 |
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Dear (Russian) friends, any ideas how/where I can get this article? The title "PATIENTS RISK" ПРИ ПРОВЕДЕНИИ ИССЛЕДОВАНИЙ БИОЭКВИВАЛЕНТНОСТИ 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 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Astea ★★ Russia, 2019-12-04 08:40 (1827 d 16:58 ago) @ Helmut Posting: # 20912 Views: 9,584 |
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Dear Helmut! I'll send you a mail. — "Being in minority, even a minority of one, did not make you mad" |
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Helmut ★★★ Vienna, Austria, 2019-12-04 11:58 (1827 d 13:40 ago) @ Astea Posting: # 20914 Views: 9,578 |
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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 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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mittyri ★★ Russia, 2019-12-04 12:29 (1827 d 13:08 ago) @ Helmut Posting: # 20917 Views: 9,546 |
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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 |
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PharmCat ★ Russia, 2019-12-04 16:16 (1827 d 09:22 ago) @ Helmut Posting: # 20924 Views: 9,494 |
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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. |
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Helmut ★★★ Vienna, Austria, 2019-12-04 18:16 (1827 d 07:22 ago) @ PharmCat Posting: # 20926 Views: 9,484 |
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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 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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nobody nothing 2019-12-04 19:12 (1827 d 06:26 ago) @ Helmut Posting: # 20927 Views: 9,464 |
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We all know for sure for decades: War Is Peace, Freedom Is Slavery, Ignorance Is Strength No way around that... — Kindest regards, nobody |
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PharmCat ★ Russia, 2019-12-04 19:12 (1827 d 06:25 ago) @ Helmut Posting: # 20928 Views: 9,467 |
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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. |
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Astea ★★ Russia, 2019-12-04 19:15 (1827 d 06:23 ago) @ Helmut Posting: # 20929 Views: 9,452 |
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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" |
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Helmut ★★★ Vienna, Austria, 2019-12-04 20:15 (1827 d 05:23 ago) @ Astea Posting: # 20930 Views: 9,417 |
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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 — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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PharmCat ★ Russia, 2019-12-05 12:09 (1826 d 13:29 ago) @ Astea Posting: # 20931 Views: 9,361 |
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❝ 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? |
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Helmut ★★★ Vienna, Austria, 2019-12-06 11:37 (1825 d 14:01 ago) @ PharmCat Posting: # 20936 Views: 9,273 |
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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 Being and Time. Even the German original is practically incomprehensible. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Astea ★★ Russia, 2019-12-06 12:52 (1825 d 12:46 ago) @ Helmut Posting: # 20938 Views: 9,254 |
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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  — "Being in minority, even a minority of one, did not make you mad" |
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mittyri ★★ Russia, 2019-12-06 13:04 (1825 d 12:34 ago) @ Helmut Posting: # 20939 Views: 9,328 |
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Hi Helmut, ❝ If you want to get a headache I suggest Martin Heidegger’s 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   — Kind regards, Mittyri |
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nobody nothing 2019-12-06 22:33 (1825 d 03:04 ago) @ mittyri Posting: # 20951 Views: 9,213 |
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— Kindest regards, nobody |
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Helmut ★★★ Vienna, Austria, 2019-12-07 21:11 (1824 d 04:26 ago) @ nobody Posting: # 20956 Views: 9,159 |
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N’Abend! Was wieder einmal zeigt: “Deutscher Humor” ist ein Widerspruch in sich selbst.  — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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nobody nothing 2019-12-07 21:30 (1824 d 04:07 ago) @ Helmut Posting: # 20957 Views: 9,175 |
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....jjjjjiiiiaaaaaaa, ... aber nein. — Kindest regards, nobody |
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Helmut ★★★ Vienna, Austria, 2019-12-07 21:42 (1824 d 03:56 ago) @ nobody Posting: # 20958 Views: 9,155 |
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N’Abend! ❝ ....jjjjjiiiiaaaaaaa, ... aber nein. T’schuidig’n! Familiär vorbelastet (mit einer Gewinnerin des ![[image]](https://static.bebac.at/img/Favicon_wikipedia_de.gif) Deutschen [sic] Kleinkunstpreises verheiratet). Kritisch und so.— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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nobody nothing 2019-12-07 22:21 (1824 d 03:17 ago) @ Helmut Posting: # 20960 Views: 9,172 |
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Lisa Eckhart? Glückwunsch! Ick korrigiere, ich denke, ich habe die richtige Dame gefunden. Das Hobby hat sie verraten... — Kindest regards, nobody |
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PharmCat ★ Russia, 2019-12-07 00:26 (1825 d 01:12 ago) @ Helmut Posting: # 20953 Views: 9,290 |
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❝ If you want to get a headache I suggest Martin Heidegger’s 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.  Hi, Astea! ❝ You may also turn to Pelevin's "Crystal World" for the subject of surreal world as well 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. |
Ing. Helmut Schütz