PE restriction for HVDs/HVDPs; testing effects [Study Assessment]
Hi John,
If we are dealing with unscaled ABE, ElMaestro’s answer (and your doubt) is correct: No way.
VSL’s post is ambiguous:
If the study was reference-scaled, the (implied) BE limits may be much wider (my answer).
Example in FDA’s flavor: CVWR 60%, implied limits 60.96–164.04%, CI 97.00–162.00%; would pass (CI within limits), but fail due to the PE of 125.36 >125.00%.
❝ You guys are messing with me... If the T/R Ratio is <0.8 or >1.25, how can you generate a 90 CI that is within 80.00 – 125.00 since the 90% CI consists of (PE ± values)?
If we are dealing with unscaled ABE, ElMaestro’s answer (and your doubt) is correct: No way.
VSL’s post is ambiguous:
❝ Study is passed in CI but mean T/R ratio is not within the 0.80-1.25.
If the study was reference-scaled, the (implied) BE limits may be much wider (my answer).
Example in FDA’s flavor: CVWR 60%, implied limits 60.96–164.04%, CI 97.00–162.00%; would pass (CI within limits), but fail due to the PE of 125.36 >125.00%.
—
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Helmut Schütz
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Science Quotes
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
Complete thread:
- Study Results VSL 2015-04-20 21:46 [Study Assessment]
- Study Results ElMaestro 2015-04-20 23:47
- upper CL < PE Helmut 2015-04-21 00:39
- PE restriction for HVDs/HVDPs; testing effects Helmut 2015-04-21 00:24
- PE restriction for HVDs/HVDPs; testing effects jag009 2015-04-21 16:49
- PE restriction for HVDs/HVDPs; testing effectsHelmut 2015-04-21 17:12
- PE restriction for HVDs/HVDPs; testing effects jag009 2015-04-22 15:47
- PE restriction for HVDs/HVDPs Helmut 2015-04-22 16:41
- PE restriction for HVDs/HVDPs; testing effects jag009 2015-04-22 15:47
- PE restriction for HVDs/HVDPs; testing effectsHelmut 2015-04-21 17:12
- GMR outside the limits when using ABEL Averroes 2017-05-19 11:53
- Regulations ≠ Science Helmut 2017-05-19 14:07
- Regulations ≠ Science Averroes 2017-05-22 20:51
- Regulations ≠ Science Helmut 2017-05-19 14:07
- PE restriction for HVDs/HVDPs; testing effects jag009 2015-04-21 16:49
- Study Results ElMaestro 2015-04-20 23:47