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RegisterA reviewer which doesn't review isn't a good reviewer [Power / Sample Size]
Dear Helmut, dear Daniel!
Funny stuff.
The very best IMHO:
"... Statistical analysis of the PK parameters (I see Helmut breathing deep
) including these two (2) subjects are within acceptable limits (LAUC 0.87 - 1.01%, LAUCinf 0.92 - 1.05% and LCmax 0.8 - 1.15%).
The DBE comment: The reviewer has reviewed the information submitted and the firm's response is acceptable." (sic!)
Ok not being so straight nitpicking and viewing the % as due to the Druckfehlerteufel (typo gremlin) it must be stated: CI's given as ratios with 2 decimals acceptable!
And that within that regulatory body which is responsible for the rule "...![[image]](img/uploaded/IAsmall.png)
to pass a CI limit of 80 to 125, the value would be at least 80.00 and not more than 125.00 ..." (clearly meant as %) now also adapted by the EMA 
.
I bet a case of best Czech beer that the lower limit for Cmax was something like 0.7988
(Helmut's alarm bell ringing).
Ein Taucher der nicht taucht taugt nichts. (german wordplay)
Funny stuff.
The very best IMHO:
"... Statistical analysis of the PK parameters (I see Helmut breathing deep
) including these two (2) subjects are within acceptable limits (LAUC 0.87 - 1.01%, LAUCinf 0.92 - 1.05% and LCmax 0.8 - 1.15%).The DBE comment: The reviewer has reviewed the information submitted and the firm's response is acceptable." (sic!)
Ok not being so straight nitpicking and viewing the % as due to the Druckfehlerteufel (typo gremlin) it must be stated: CI's given as ratios with 2 decimals acceptable!
And that within that regulatory body which is responsible for the rule "...
to pass a CI limit of 80 to 125, the value would be at least 80.00 and not more than 125.00 ..." (clearly meant as %) now also adapted by the EMA .I bet a case of best Czech beer that the lower limit for Cmax was something like 0.7988
(Helmut's alarm bell ringing).Ein Taucher der nicht taucht taugt nichts. (german wordplay)
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- Parallel BE drcampos 2012-04-10 16:11
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Parallel BE Helmut 2012-04-10 17:20
- Parallel BE drcampos 2012-04-10 21:03
- FDA’s review Helmut 2012-04-11 02:22
- A reviewer which doesn't review isn't a good reviewerd_labes 2012-04-11 09:57
- 14 months for 1st review Helmut 2012-04-11 13:51
- Guidelines - nonbinding, Scientific advice - nonbinding … d_labes 2012-04-11 15:50
- Grumpy ol’ men Helmut 2012-04-11 16:22
- Grumpy ol’ men - OT d_labes 2012-04-11 17:04
- GDR - OT Helmut 2012-04-11 17:47
- Grumpy ol’ men - OT d_labes 2012-04-11 17:04
- Grumpy ol’ men Helmut 2012-04-11 16:22
- Guidelines - nonbinding, Scientific advice - nonbinding … d_labes 2012-04-11 15:50
- 14 months for 1st review Helmut 2012-04-11 13:51
- A reviewer which doesn't review isn't a good reviewerd_labes 2012-04-11 09:57
- FDA’s review Helmut 2012-04-11 02:22
- Parallel BE drcampos 2012-04-10 21:03
- Parallel BE Helmut 2012-04-10 17:20
Ing. Helmut Schütz