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Helmut ★★★   Vienna, Austria, 2015-06-08 14:35 (3608 d 22:41 ago) Posting: # 14925 Views: 10,001 |
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Dear all, just found an interesting statement in an EPAR of 2013: The CHMP raised questions about the appropriateness of calculations using below limit of quantitation (BLQ) and exclusion of data. The applicant provided re-evaluated PK parameters and statistical analysis not replacing BLQ with the half value of lower limit of quantitation (LLOQ). (my emphasis)— 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, 2015-06-08 15:31 (3608 d 21:45 ago) @ Helmut Posting: # 14926 Views: 8,237 |
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Dear Helmut! Using 0 (zero) instead for that BLOQ? Or exclude (the text names exclusion of data)? — Regards, Detlew |
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Helmut ★★★ Vienna, Austria, 2015-06-08 16:02 (3608 d 21:15 ago) @ d_labes Posting: # 14927 Views: 8,449 |
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Dear Detlew! ❝ Using 0 (zero) instead for that BLOQ? Do you remember this thread? ❝ Or exclude (the text names exclusion of data)? I’m not sure which data were originally presented. From the wording in the EPAR I guess that the applicant set BQLs between two measurable samples to LLOQ/2. Duno what they have done with the first BLQ in the elimination. Some people set this value to LLOQ/2 as well.
— 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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ElMaestro ★★★ Denmark, 2015-06-08 16:37 (3608 d 20:39 ago) @ Helmut Posting: # 14928 Views: 8,192 |
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Haha, strictly speaking this one still applies, no? But they forgot that BE trials are confirmatory as well, and that the conservative population in BE is the PP population and not the ITT populaton. Go ahead, try and claim you are compliant with LOCF  — Pass or fail! ElMaestro |
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d_labes ★★★ Berlin, Germany, 2015-06-08 16:51 (3608 d 20:25 ago) @ Helmut Posting: # 14929 Views: 8,254 |
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Dear Helmut! ❝ Do you remember this thread? Yesss Sir. Oh! That nasty "triangular points" again! My habit up to now was to take a value of zero for them. Contrary to what ANVISA expects (exclude = identical with interpolate) and what you do (interpolate) if I remember it right from the above mentioned post. Of course only until tlast. — Regards, Detlew |
Ing. Helmut Schütz