Playing around with α (not exactly brilliant) [Regulatives / Guidelines]
Hi ElMaestro,
Yep, but (big but): Your α will necessarily be (much) larger than 0.05. Let’s not warm-up the dispute RA Fisher had with Jerzy Neyman. At least I don’t want to go there.
THX, I do understand what you mean.
Sure. Would you prefer to say “The risk for the patient to have a BA outside 80–125% of the reference is 31.42%”?
❝ – For any CV measured I can define a revised alpha that keeps the original acceptance range in place (80.00%-125.00%), and which achieves exactly the same (it rejects and accepts exactly the same products as your approach).
Yep, but (big but): Your α will necessarily be (much) larger than 0.05. Let’s not warm-up the dispute RA Fisher had with Jerzy Neyman. At least I don’t want to go there.

❝ I can probably work out an example if you need one?
THX, I do understand what you mean.
❝ My point was/is that changing the acceptance range for the CI in mathematical terms does exactly the same as keeping the acceptance range while changing the applied alpha.
Sure. Would you prefer to say “The risk for the patient to have a BA outside 80–125% of the reference is 31.42%”?
—
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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Complete thread:
- HC Proposed Policy on Bioequivalence Standards for HVDS balakotu 2015-07-02 09:05 [Regulatives / Guidelines]
- HC Proposed Policy on Bioequivalence Standards for HVDS d_labes 2015-07-02 09:19
- Bloody partial replicate again Helmut 2015-07-02 13:20
- Bloody partial replicate again Lucas 2015-07-02 13:35
- Which model? Helmut 2015-07-02 16:41
- Which model? Lucas 2015-07-02 18:06
- Which model? Helmut 2015-07-02 16:41
- Bloody partial replicate again Lucas 2015-07-02 13:35
- HC Proposed Policy on Bioequivalence Standards for HVDS drgunasakaran1 2015-07-02 17:08
- AUC and Cmax Helmut 2015-07-02 17:37
- HC for HVDs d_labes 2015-07-03 08:21
- HC for HVDs Helmut 2015-07-03 11:55
- Rounding d_labes 2015-07-03 12:53
- Acceptable difference (BE history) Helmut 2015-07-03 14:49
- Off topic ElMaestro 2015-07-03 13:02
- Playing around with α (not exactly brilliant) Helmut 2015-07-03 15:38
- Playing around with α (not exactly brilliant) ElMaestro 2015-07-03 16:35
- Playing around with α (not exactly brilliant)Helmut 2015-07-03 16:44
- OT – Philosophers on duty d_labes 2015-07-03 21:11
- Playing around with α (not exactly brilliant)Helmut 2015-07-03 16:44
- Playing around with α (not exactly brilliant) ElMaestro 2015-07-03 16:35
- Playing around with α (not exactly brilliant) Helmut 2015-07-03 15:38
- Rounding d_labes 2015-07-03 12:53
- HC for HVDs Helmut 2015-07-03 11:55