3 period full replicate [RSABE / ABEL]
Hi Dr_Dan,
How about something like:
"From a statistical perspective the added value of a fully replicated trial, in contrast to a semi-replicated trial, is that it contributes direct information about the within-subject variability for the Test product. This information has, however, in its own right no regulatory use because:

❝ My interest is just of academic nature: What should one reply to this attitude?
How about something like:
"From a statistical perspective the added value of a fully replicated trial, in contrast to a semi-replicated trial, is that it contributes direct information about the within-subject variability for the Test product. This information has, however, in its own right no regulatory use because:
- Population bioequivalence and individual bioequivalence are abandoned concepts.
- Reference-scaled bioequivalence relies solely on estimates of Test and Reference fixed effects along with within-subject variability associated with the Reference product (all of which are provided via a semi-replicated trial).

—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- 3 period full replicate Dr_Dan 2015-06-24 13:55 [RSABE / ABEL]
- 3 period full replicateElMaestro 2015-06-24 14:11
- 3 period full replicate Helmut 2015-06-24 14:29
- 3 period full replicate d_labes 2015-06-24 14:38
- 3 period full replicate Dr_Dan 2015-06-24 16:43
- 3 period full replicate Helmut 2015-06-24 18:00
- 3 period full replicate ElMaestro 2015-06-24 18:11
- 3 period full replicate Helmut 2015-06-24 18:25
- 3 period full replicate d_labes 2015-06-25 08:52
- 3 period full replicate ElMaestro 2015-06-25 10:37
- 3 period full replicate d_labes 2015-06-25 08:52
- 3 period full replicate Helmut 2015-06-24 18:25
- 3 period full replicate ElMaestro 2015-06-24 18:11
- CVs (borderline OT) Helmut 2015-06-26 13:51
- CVs (R, T) from pooled CV d_labes 2015-07-02 09:09
- Answering an unasked question Helmut 2015-07-02 13:03
- Answer to an unasked answer d_labes 2015-07-02 14:21
- Bloody typo! Helmut 2015-07-02 14:33
- Answer to an unasked answer d_labes 2015-07-02 14:21
- Answering an unasked question Helmut 2015-07-02 13:03
- CVs (borderline OT) zizou 2015-07-05 19:20
- Degrees of freedom 3-period full replicate d_labes 2015-07-06 11:10
- Degrees of freedom 3-period full replicate ElMaestro 2015-07-06 11:59
- Degrees of freedom 3-period full replicate d_labes 2015-07-06 13:53
- Degrees of freedom 3-period full replicate zizou 2015-07-06 17:25
- Degrees of freedom 3-period full replicate ElMaestro 2015-07-06 11:59
- Degrees of freedom 3-period full replicate d_labes 2015-07-06 11:10
- CVs (R, T) from pooled CV d_labes 2015-07-02 09:09
- 3 period full replicate Helmut 2015-06-24 18:00
- 3 period full replicate Dr_Dan 2015-06-24 16:43
- The almighty oracle has spoken! Helmut 2015-07-23 23:54
- Almighty oracle's mysterious saying d_labes 2015-07-24 08:23