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RegisterCV values in BE studies: intra, or inter, or total? [Study Assessment]
Hello to all.
There is data about CV values (often these values are placed into brackets) in many published reports of BE studies.
I'll provide two examples in order to make my BIG question clear:
1. In a single dose, randomised 3-way cross-over bioequivalence study, comparing the proposed 160 mg product with two reference 160mg tablets from France (Sotalex, Bristol Myers Squibb, France) and Australia (Sotacor, Bristol Myers Squibb, Australia) in healthy adult male volunteers under fasting conditions such results were obtained:
Ln Cmax(ng/ml) for Sotalex-French Reference tablets 160 mg: Mean (CV) = 1212.09 (28.7)
The link to the source: http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con2031163.pdf
2. In a another randomized two-dose two-period crossover study on the bioequivalence of oral and intravenous sotalol CV for Cmax (oral route of administration) was 0.41. This value was performed in a separate cell of a table (that table contained data about individual levels of PK parameters of participants, min, max, mean, median as well; you can check it here: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022306s000ClinPharmR.pdf)
The question:
Which kind of CV is performed in my examples? And in general which kind of CV is usually performed in reports of BE studies? Is it CVintra, or CVinter, or CVtotal?
Edit: Please don’t shout! [Helmut]
There is data about CV values (often these values are placed into brackets) in many published reports of BE studies.
I'll provide two examples in order to make my BIG question clear:
1. In a single dose, randomised 3-way cross-over bioequivalence study, comparing the proposed 160 mg product with two reference 160mg tablets from France (Sotalex, Bristol Myers Squibb, France) and Australia (Sotacor, Bristol Myers Squibb, Australia) in healthy adult male volunteers under fasting conditions such results were obtained:
Ln Cmax(ng/ml) for Sotalex-French Reference tablets 160 mg: Mean (CV) = 1212.09 (28.7)
The link to the source: http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con2031163.pdf
2. In a another randomized two-dose two-period crossover study on the bioequivalence of oral and intravenous sotalol CV for Cmax (oral route of administration) was 0.41. This value was performed in a separate cell of a table (that table contained data about individual levels of PK parameters of participants, min, max, mean, median as well; you can check it here: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022306s000ClinPharmR.pdf)
The question:
Which kind of CV is performed in my examples? And in general which kind of CV is usually performed in reports of BE studies? Is it CVintra, or CVinter, or CVtotal?
Edit: Please don’t shout! [Helmut]
Complete thread:
- CV values in BE studies: intra, or inter, or total?Elena777 2018-01-20 12:31 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- CV values in BE studies: intra, or inter, or total? jag009 2018-01-20 19:18
- CV values in BE studies: intra, or inter, or total? Elena777 2018-01-20 21:10
- CV values in BE studies: intra, or inter, or total? jag009 2018-01-21 03:17
- CV values in BE studies: intra, or inter, or total? Elena777 2018-01-21 08:21
- CV values in BE studies: intra, or inter, or total? jag009 2018-01-21 03:17
- CV values in BE studies: intra, or inter, or total? Elena777 2018-01-20 21:10
- CV values in BE studies: intra, or inter, or total? Helmut 2018-01-21 17:33
- CV values in BE studies: intra, or inter, or total? ElMaestro 2018-01-21 18:17
- CV values in BE studies: intra, or inter, or total? Elena777 2018-01-27 09:57
- CV values in BE studies: intra, or inter, or total? Louis52 2018-02-07 20:22
- CV values in BE studies: intra, or inter, or total? Helmut 2018-02-07 20:31
- CV values in BE studies: intra, or inter, or total? Rosy 2019-02-19 18:33
- PowerTOST: CVfromCI Helmut 2019-02-20 13:00
- PowerTOST: CVfromCI -> CI.BE d_labes 2019-02-20 14:12
- PowerTOST: CVfromCI Rosy 2019-02-20 15:25
- type known.designs() in PowerTOST Helmut 2019-02-20 16:14
- type known.designs() in PowerTOST Rosy 2019-02-20 17:14
- type known.designs() in PowerTOST Helmut 2019-02-20 16:14
- PowerTOST: CVfromCI Helmut 2019-02-20 13:00
- CV values in BE studies: intra, or inter, or total? Rosy 2019-02-19 18:33
- CV values in BE studies: intra, or inter, or total? Helmut 2018-02-07 20:31
- CV values in BE studies: intra, or inter, or total? Louis52 2018-02-07 20:22
- CV values in BE studies: intra, or inter, or total? Elena777 2018-01-27 09:57
- CV values in BE studies: intra, or inter, or total? jag009 2018-01-20 19:18
Ing. Helmut Schütz