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Dear ElMaestro,
In very short: All effects fixed, that means without loss of generality no period, no sequence and no subject effects (! according to EM
) i.e. all set to zero. Normal distribution of the log(PKmetric) with µT = log(GMR) + µR and s2wT for the period a subject receives Test and µR and s2wR for the periods a subject receives Reference. s2wX as usual = log(1.0 + CVwX^2).
Apply the EMA evaluation, i.e. calculate the 90% CI's and count studies with CI in usual acceptance range (note we are talking here about the ABE term).
❝ Btw: Talking about CVwT sound odd for a 3-period study where just the ref is replicated. Can you elaborate how these sims were performed?
In very short: All effects fixed, that means without loss of generality no period, no sequence and no subject effects (! according to EM
) i.e. all set to zero. Normal distribution of the log(PKmetric) with µT = log(GMR) + µR and s2wT for the period a subject receives Test and µR and s2wR for the periods a subject receives Reference. s2wX as usual = log(1.0 + CVwX^2).Apply the EMA evaluation, i.e. calculate the 90% CI's and count studies with CI in usual acceptance range (note we are talking here about the ABE term).
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Regards,
Detlew
Regards,
Detlew
Complete thread:
- Partial replicate design, EMA evaluation, Type I error d_labes 2013-08-09 14:49 [Power / Sample Size]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Partial replicate design, EMA evaluation, Type I error ElMaestro 2013-08-09 15:29
- How to simd_labes 2013-08-09 15:56
- How to sim ElMaestro 2013-08-09 19:49
- How to simd_labes 2013-08-09 15:56
- Partial replicate design, EMA evaluation, Type I error ElMaestro 2013-08-09 15:29
Ing. Helmut Schütz