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RegisterTest/Reference Ratio [Power / Sample Size]
Dear drplacebo,
Unless you intend to submit your data to Denmark, where such a ratio may lead to difficulties, all which matters to the regulators is your 90 % CI. The result of the point estimate is not taken into consideration in the guidelines to accept or reject bioequivalence.
The question is more whether such a difference is acceptable from the sponsor's point of view, and whether they should take the chance, or rather re-formulate the product. The decision would depend on the number of subjects in the pilot study (and therefore, how reliable your estimated ratio is), and on the intra-subject CV (little chances to demonstrate bioequivalence with a point estimate at 112 % and a high CV).
Regards
Ohlbe
❝ Will this be acceptable from regulatory point of view?
Unless you intend to submit your data to Denmark, where such a ratio may lead to difficulties, all which matters to the regulators is your 90 % CI. The result of the point estimate is not taken into consideration in the guidelines to accept or reject bioequivalence.
The question is more whether such a difference is acceptable from the sponsor's point of view, and whether they should take the chance, or rather re-formulate the product. The decision would depend on the number of subjects in the pilot study (and therefore, how reliable your estimated ratio is), and on the intra-subject CV (little chances to demonstrate bioequivalence with a point estimate at 112 % and a high CV).
Regards
Ohlbe
Complete thread:
- Test/Reference Ratio drplacebo 2008-09-12 11:41
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Test/Reference RatioOhlbe 2008-09-12 12:25
- Test/Reference Ratio Helmut 2008-09-19 17:11
- Test/Reference Ratio SKR 2008-10-03 09:08
Ing. Helmut Schütz