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RegisterGood question! [Nonparametrics]
posted by Helmut 
– Vienna, Austria, 2012-01-17 12:34 (4867 d 20:35 ago) – Posting: # 7954
Views: 15,334
Dear Joshua!
Good point. Since tmax is not required for the FDA, I guess you are referring to the EMA’s GL?
in the discussion section of the report. How can we assess the variabilities? I would go with reporting the products’ IQRs followed by . In a partial replicate I would mean the two administrations of the reference.
❝ Can anyone kindly guide on how to do the non-parametric analysis for tmax for a two treatment, three period, three sequence (partial replicate) design.
Good point. Since tmax is not required for the FDA, I guess you are referring to the EMA’s GL?
A statistical evaluation of tmax is not required. However, if rapid release is claimed to be clinically relevant and of importance for onset of action or is related to adverse events, there should be no apparent difference in median tmax and its variability between test and reference product.
The EMA hates nonparametrics – which is manifested in the first sentence. ‘No apparent difference in median tmax’ without statistics boils down to in the discussion section of the report. How can we assess the variabilities? I would go with reporting the products’ IQRs followed by . In a partial replicate I would mean the two administrations of the reference.—
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Helmut Schütz
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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
Complete thread:
- Tmax in Partial Replicate Design Joshua 2012-01-17 06:59 [Nonparametrics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Good question!Helmut 2012-01-17 11:34
- Good question! Joshua 2012-01-20 11:54
- Early exposure (+scaling?) Helmut 2012-01-20 12:56
- Good question! Joshua 2012-01-20 11:54
- Tmax in Partial replicate design d_labes 2012-01-20 11:12
- Tmax in Partial replicate design Joshua 2012-01-20 12:09
- Intra-subject contrast (difference) d_labes 2012-01-20 12:55
- Intra-subject contrast (difference) Joshua 2012-01-20 13:01
- Wilcoxon for 2x2x4. "Not many things easier than that"? Astea 2023-02-14 18:44
- Intra-subject contrast (difference) d_labes 2012-01-20 12:55
- Tmax in Partial replicate design mittyri 2017-01-03 23:24
- ISC and Wilcoxon signed rank test d_labes 2017-01-04 10:21
- ISC and Wilcoxon signed rank test in coin package mittyri 2017-01-04 14:17
- ISC and Wilcoxon signed rank test in coin package d_labes 2017-01-04 16:09
- ISC and Wilcoxon signed rank test in coin package mittyri 2017-01-04 14:17
- ISC and Wilcoxon signed rank test d_labes 2017-01-04 10:21
- Tmax in Partial replicate design Joshua 2012-01-20 12:09
- Good question!Helmut 2012-01-17 11:34
Ing. Helmut Schütz