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RegisterDifferent doses or strenghts? [General Statistics]
Dear kumarnaidu
You are talking about a two period cross-over study with 4 treatments, right?
I am not a statistician but I guess it would be reasonable to divide R also into 3 groups with 5 subjects each so that you have an intra-individual comparison T1 vs R1, T2 vs R2 and T3 vs R3. If possible I would prefer a 4 way cross over design, three times test one reference with 5 subjects each.
Bioequivalence: Two medicinal products are bioequivalent if they are pharmaceutically equivalent and if their bioavailabilities after administration in the same molar dose are similar to such degree that their effects, with respect to both efficacy and safety, will be essentially the same. I guess in your case we are talking about comparative bioavailabilities and the test products are no pure generic formulations, right?
Kind regards
Dan
You are talking about a two period cross-over study with 4 treatments, right?
I am not a statistician but I guess it would be reasonable to divide R also into 3 groups with 5 subjects each so that you have an intra-individual comparison T1 vs R1, T2 vs R2 and T3 vs R3. If possible I would prefer a 4 way cross over design, three times test one reference with 5 subjects each.
Bioequivalence: Two medicinal products are bioequivalent if they are pharmaceutically equivalent and if their bioavailabilities after administration in the same molar dose are similar to such degree that their effects, with respect to both efficacy and safety, will be essentially the same. I guess in your case we are talking about comparative bioavailabilities and the test products are no pure generic formulations, right?
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Dose based on m² VK 2013-07-17 10:35
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Dose based on m² Dr_Dan 2013-07-17 11:09
- Dose based on m² VK 2013-07-17 16:17
- Different doses or strenghts? Helmut 2013-07-17 12:18
- Different doses or strenghts? VK 2013-07-17 16:31
- No problem with same strength but different doses Helmut 2013-07-17 23:17
- Different doses or strenghts? luvblooms 2013-07-18 06:42
- Different doses or strenghts? VK 2013-07-18 15:28
- Different doses or strenghts? kumarnaidu 2013-11-21 14:00
- Different doses or strenghts?Dr_Dan 2013-11-21 15:23
- Different doses or strenghts? kumarnaidu 2013-11-22 05:34
- Different doses or strenghts?Dr_Dan 2013-11-21 15:23
- Different doses or strenghts? kumarnaidu 2013-11-21 14:00
- Different doses or strenghts? VK 2013-07-18 15:28
- Different doses or strenghts? VK 2013-07-17 16:31
- Dose based on m² Dr_Dan 2013-07-17 11:09
Ing. Helmut Schütz