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RegisterCI calculation in full replicate design [RSABE / ABEL]
Dear John,
Maybe my question is not clear. Let me rephrase.
Referring to the progesterone guidance, Step 1, if SWR ≥ 0.294, use the reference-scaled procedure to determine BE for the individual PK parameters. We follow the steps and calculate until Step 3a and b. Both Cmax and AUC pass.
My question is :
Do we stop here or we also need to calculate the 90% confidence interval for Cmax and AUC ?
Step 3b is only point estimate.
In the event we need to calculate the 90%CI, how to do it ??
Your feedback is highly appreciated.
Thank you.
Regards,
Ken
Maybe my question is not clear. Let me rephrase.
Referring to the progesterone guidance, Step 1, if SWR ≥ 0.294, use the reference-scaled procedure to determine BE for the individual PK parameters. We follow the steps and calculate until Step 3a and b. Both Cmax and AUC pass.
My question is :
Do we stop here or we also need to calculate the 90% confidence interval for Cmax and AUC ?
Step 3b is only point estimate.
In the event we need to calculate the 90%CI, how to do it ??
Your feedback is highly appreciated.
Thank you.
Regards,
Ken
Complete thread:
- CI calculation in full replicate design Ken Peh 2013-06-03 19:11
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- CI calculation in full replicate design jag009 2013-06-03 20:06
- CI calculation in full replicate designKen Peh 2013-06-05 12:43
- CI not needed in RSABE Helmut 2013-06-05 13:40
- CI not needed in RSABE Ken Peh 2013-06-05 17:31
- CI calculation in full replicate design jag009 2013-06-05 19:56
- CI not needed in RSABE Helmut 2013-06-05 13:40
- CI calculation in full replicate designKen Peh 2013-06-05 12:43
- CI calculation in full replicate design jag009 2013-06-03 20:06
Ing. Helmut Schütz