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RegisterSignificance [Power / Sample Size]
Goodmorning everyone,
I have a question. Let's say Cmax for the test product is somewhat lower than for the reference product, but the confidence intervals are well within the acceptance criteria of 80 to 125% though it does not include unity (ie. 85 to 97). Let's say that during a deficiency letter an assessor claims the difference is significant. On what basis can they claim this significant difference (our client believes it is because the F-factor/test for treatment is significant—is this an appropriate test to use in this instance and can someone explain what it means in this context)? And how would one go about responding to such a claim (of significance)?
Personally, I'm focusing on the study results being compliant with the guideline requirements (Cmax is within the confidence intervals). Since this is the case, whatever difference in Cmax between test and reference products are non-significant. Is this correct? Comments?
Thank you in advance for any feedback you can provide.
Category changed. [Helmut]
I have a question. Let's say Cmax for the test product is somewhat lower than for the reference product, but the confidence intervals are well within the acceptance criteria of 80 to 125% though it does not include unity (ie. 85 to 97). Let's say that during a deficiency letter an assessor claims the difference is significant. On what basis can they claim this significant difference (our client believes it is because the F-factor/test for treatment is significant—is this an appropriate test to use in this instance and can someone explain what it means in this context)? And how would one go about responding to such a claim (of significance)?
Personally, I'm focusing on the study results being compliant with the guideline requirements (Cmax is within the confidence intervals). Since this is the case, whatever difference in Cmax between test and reference products are non-significant. Is this correct? Comments?
Thank you in advance for any feedback you can provide.
Category changed. [Helmut]
Complete thread:
- SignificanceThe Outlaw Torn 2012-11-20 07:56 [Power / Sample Size]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Significance ElMaestro 2012-11-20 08:17
- Significance The Outlaw Torn 2012-11-20 08:55
- Quality vs. Clinical ElMaestro 2012-11-20 09:04
- Significance The Outlaw Torn 2012-11-20 08:55
- Sample size? Helmut 2012-11-20 20:10
- Sample size? The Outlaw Torn 2012-11-21 07:52
- Sample size? The Outlaw Torn 2012-11-22 10:55
- Sample size, ratio, CV ↔ power Helmut 2012-11-22 13:35
- Sample size, ratio, CV ↔ power The Outlaw Torn 2012-11-23 14:47
- Sample size, ratio, CV ↔ power BEQool 2025-01-31 13:12
- TOST != treatment effect mittyri 2025-02-20 13:13
- Sample size, ratio, CV ↔ power zizou 2025-02-21 13:40
- Not vice versa mittyri 2025-02-22 21:08
- Not vice versa? zizou 2025-02-24 11:02
- Not vice versa? mittyri 2025-02-25 06:12
- Not vice versa? zizou 2025-02-24 11:02
- Not vice versa mittyri 2025-02-22 21:08
- Sample size, ratio, CV ↔ power Helmut 2012-11-22 13:35
- Sample size calculation using Marzo and Balant method kumarnaidu 2013-01-31 07:48
- Marzo / Balant formula d_labes 2013-01-31 10:05
- Marzo / Balant formula kumarnaidu 2013-01-31 10:54
- Marzo / Balant formula kumarnaidu 2013-02-04 05:48
- Marzo / Balant formula for parallel groups d_labes 2013-02-04 08:44
- Marzo / Balant formula kumarnaidu 2013-02-04 05:48
- Marzo / Balant formula kumarnaidu 2013-01-31 10:54
- Marzo / Balant formula d_labes 2013-01-31 10:05
- Significance ElMaestro 2012-11-20 08:17
Ing. Helmut Schütz