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Back to the forum  2018-06-22 07:28 CEST (UTC+2h)

95% Upper bound calculation [RSABE / ABEL]

posted by Katrin_Ti - Austria, 2018-03-13 09:31  - Posting: # 18526
Views: 471

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

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