Log in
Register95% Upper bound calculation [RSABE / ABEL]
Hi,
as the guidence for acyclovir creams defines:
The replicate skin sections from donor 1 dosed with the test product may be denoted as T11,
T21, ..., Tr1, and likewise from donor 2, T12, T22, ..., Tr2, and so forth up to n donors; T1n,
T2n, ..., Trn. Similarly, the replicate skin sections dosed with the RLD product may be denoted as R1n, R2n, ..., Rrn.
That means that you need the same number of replicates from each donor (for R and T) for further calculations.
Calculate the point estimate, inter-donor variability and within reference variability using the log-transformed data (as defined in the acyclovir cream guidance).
If SWR >= 0.294 use the RSABE approach and calculate the upper bound of the CI as described in the Progesterone guidance.
I think the SAS code described in the progesterone guidance has to be modified but I can not help you with this task.
Greetings
as the guidence for acyclovir creams defines:
The replicate skin sections from donor 1 dosed with the test product may be denoted as T11,
T21, ..., Tr1, and likewise from donor 2, T12, T22, ..., Tr2, and so forth up to n donors; T1n,
T2n, ..., Trn. Similarly, the replicate skin sections dosed with the RLD product may be denoted as R1n, R2n, ..., Rrn.
That means that you need the same number of replicates from each donor (for R and T) for further calculations.
Calculate the point estimate, inter-donor variability and within reference variability using the log-transformed data (as defined in the acyclovir cream guidance).
If SWR >= 0.294 use the RSABE approach and calculate the upper bound of the CI as described in the Progesterone guidance.
I think the SAS code described in the progesterone guidance has to be modified but I can not help you with this task.
Greetings
Complete thread:
- 95% Upper bound calculation GM 2018-03-07 06:25
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 95% Upper bound calculation Katrin_Ti 2018-03-09 14:05
- 95% Upper bound calculation GM 2018-03-13 05:09
- 95% Upper bound calculationKatrin_Ti 2018-03-13 09:31
- 95% Upper bound calculation GM 2018-03-13 05:09
- 95% Upper bound calculation Katrin_Ti 2018-03-09 14:05
Ing. Helmut Schütz