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RegisterDose based on m² [General Statistics]
Dear VK
What do you mean by "We did regular calculations"? In a cross-over study BE is based on the intra-individual comparison of test and reference and therefore it is theoretically possible to administer different doses (dose adjusted PK parameters). However, I guess in your case you administered a combination of different strengths (=different products), right?
For example:
70% received 1x100mg
30% received either 1x50mg+1x25mg or 1x100mg+1x25mg
Then indeed only 70% of the subjects could be evaluated since a pure comparison is only possible between your 100 mg product and the originator.
If you had choosen
70% received 4x25mg
30% received either 3x25mg or 5x25mg
Then 100% of the subjects could be evaluated.
Kind regards
Dan
What do you mean by "We did regular calculations"? In a cross-over study BE is based on the intra-individual comparison of test and reference and therefore it is theoretically possible to administer different doses (dose adjusted PK parameters). However, I guess in your case you administered a combination of different strengths (=different products), right?
For example:
70% received 1x100mg
30% received either 1x50mg+1x25mg or 1x100mg+1x25mg
Then indeed only 70% of the subjects could be evaluated since a pure comparison is only possible between your 100 mg product and the originator.
If you had choosen
70% received 4x25mg
30% received either 3x25mg or 5x25mg
Then 100% of the subjects could be evaluated.
Kind regards
Dan
—
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 m²Dr_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 m²Dr_Dan 2013-07-17 11:09
Ing. Helmut Schütz