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Helmut ★★★   Vienna, Austria, 2020-09-28 19:12 (2099 d 12:20 ago) Posting: # 21947 Views: 6,484 |
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Dear all, we know for a good while that under certain conditions the Type I Error (TIE) might be inflated. However, seemingly European assessors were either not aware of it or ignored it. Last week I saw a deficiency letter (don’t ask for the country): … in case of a value of 30% < CVRR <45%, it is recommended to check the control of the patient's risk type I error at the level of 5%. If an alpha adjustment is necessary, it is recommended that a BE estimate for the new CI of the T/R ratio be submitted to meet the extended bounds. Kudos! Almost correct. The area of inflated TIEs may reach below 30% and only rarely (say, for a 4-period full replicate in 24 subjects) to 45%. — 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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d_labes ★★★ Berlin, Germany, 2020-09-28 19:51 (2099 d 11:41 ago) @ Helmut Posting: # 21948 Views: 4,773 |
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Dear Helmut! ❝ we know for a good while that under certain conditions the Type I Error (TIE) might be inflated. However, seemingly European assessors were either not aware of it or ignored it. Last week I saw a deficiency letter (don’t ask for the country): … in case of a value of 30% < CVRR <45%, it is recommended to check the control of the patient's risk type I error at the level of 5%. If an alpha adjustment is necessary, it is recommended that a BE estimate for the new CI of the T/R ratio be submitted to meet the extended bounds. ❝ Kudos! Almost correct. The area of inflated TIEs may reach below 30% and only rarely (say, for a 4-period full replicate in 24 subjects) to 45%. Can say only: Wow!  — Regards, Detlew |
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ElMaestro ★★★ Denmark, 2020-09-29 12:41 (2098 d 18:51 ago) @ Helmut Posting: # 21949 Views: 4,786 |
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❝ … (don’t ask for the country): … in case of a value of 30% < CVRR <45%, it is recommended to check the control of the patient's risk type I error at the level of 5%. If an alpha adjustment is necessary, it is recommended that a BE estimate for the new CI of the T/R ratio be submitted to meet the extended bounds. That subjunction is correct but not part of the everyday linguistic toolbox of those who do not speak a lot of English. My guess is MHRA or the Irish Medicines Board or it comes from someone who spent a lot of time taking English language classes  — Pass or fail! ElMaestro |
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Helmut ★★★ Vienna, Austria, 2020-09-29 12:49 (2098 d 18:43 ago) @ ElMaestro Posting: # 21950 Views: 4,777 |
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Hi ElMastro, ❝ ❝ … it is recommended that a BE estimate for the new CI of the T/R ratio be submitted to meet the extended bounds. ❝ That subjunction is correct but not part of the everyday linguistic toolbox of those who do not speak a lot of English. My guess is MHRA or the Irish Medicines Board or it comes from someone who spent a lot of time taking English language classes Not quite.  Just before the mentioned text it read: … no confirmation is provided that variability in the reference drug exists and is not caused by emissions; please provide confirmation in the form of an emissions estimate. We guessed that outliers were meant by “emissions”.— 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 |
Ing. Helmut Schütz