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Thanks, Helmut for your reply
but I am quite confused, some products show high intrasubject variability more than anticipated or published in the literature and I think this variability affect the reliability of results, for example, I have a BE study for (lansoprazole), partially replicate design, the published intrasubject variability ~ 40% but the practical intrasubject variability we had was near 85%
study protocol also stated using ema guidelines for scaling but the study failed, when I used FDA method it passes does this high variability have a role in this confusing results? also in the future protocol can I specify that if the intrasubject variability is more than 50% can I switch to the FDA method for calculation, as many authorities we submit our studies to follow ema guidelines?
Thanks in advance
but I am quite confused, some products show high intrasubject variability more than anticipated or published in the literature and I think this variability affect the reliability of results, for example, I have a BE study for (lansoprazole), partially replicate design, the published intrasubject variability ~ 40% but the practical intrasubject variability we had was near 85%
study protocol also stated using ema guidelines for scaling but the study failed, when I used FDA method it passes does this high variability have a role in this confusing results? also in the future protocol can I specify that if the intrasubject variability is more than 50% can I switch to the FDA method for calculation, as many authorities we submit our studies to follow ema guidelines?Thanks in advance
Complete thread:
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![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Outlier in fully replicate BE study drgunasakaran1 2021-06-16 08:59
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- Widening for clopidogrel BE study mittyri 2021-06-16 16:04
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- Widening for clopidogrel BE study - cherry-picking? mittyri 2021-06-16 17:27
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- Hypotheses Helmut 2021-06-19 12:32
- HypothesesLoky do 2021-07-06 11:51
- ABEL ≠ RSABE Helmut 2021-07-06 16:17
- ABEL ≠ RSABE BEQool 2023-10-09 14:47
- power.TOST.sim and uncertainty mittyri 2023-10-11 12:42
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- power.TOST.sim code BEQool 2023-11-02 11:22
- power.TOST.sim code mittyri 2023-10-31 15:40
- Distribution of PEs BEQool 2023-10-23 19:55
- Distribution of PEs Helmut 2023-10-23 10:48
- power.TOST.sim and uncertainty mittyri 2023-10-20 21:47
- power.TOST.sim and uncertainty BEQool 2023-10-15 11:29
- power.TOST.sim and uncertainty mittyri 2023-10-11 12:42
- ABEL ≠ RSABE BEQool 2023-10-09 14:47
- ABEL ≠ RSABE Helmut 2021-07-06 16:17
- HypothesesLoky do 2021-07-06 11:51
- Widening for clopidogrel BE study Loky do 2021-06-16 17:08
- Widening for clopidogrel BE study mittyri 2021-06-16 16:04
- Widening for clopidogrel BE study Loky do 2021-06-16 15:38
- Outlier in fully replicate BE study drgunasakaran1 2021-06-16 08:59
Ing. Helmut Schütz