Cmin (EU) [Surveys]
Dear Helmut,
Ad 1)
Ad 1e)
for 1.a) or 1.c) Sponsor's wish
Ad 2)
Ad 3)
Never used 3.c)
Acceptance range usually 0.8-1.25, but also widening.
Ad 4)
Usual problems in case of widening acceptance range:
"The applicant should justify the widening ... ".
Ad 5)
Ad 6)
See ad 5)
Best wishes for the New Year
Regards
D. Labes
Ad 1)
❝ How do you define Cmin in steady state?
Ad 1e)
❝ Additional question: your rationale for either of the above
for 1.a) or 1.c) Sponsor's wish
Ad 2)
❝ Do you only report values for the formulations (geometric mean, sd) ...
Ad 3)
❝ If the latter, do you use the metric in a confirmatory analysis (e.g., state an acceptance range)? ...
Never used 3.c)
Acceptance range usually 0.8-1.25, but also widening.
Ad 4)
❝ Did you have any problems with your approach?
Usual problems in case of widening acceptance range:
"The applicant should justify the widening ... ".
Ad 5)
❝ Do you see a change in point of views by European regulators ...
Ad 6)
❝ Do you consider widening of the acceptance range in a replicate design in steady state (i.e., TTRR-RRTT)
^^^^
See ad 5)
Best wishes for the New Year
Regards
D. Labes
Complete thread:
- Cmin (EU) Helmut 2009-12-21 13:08
- Cmin (EU) ElMaestro 2009-12-22 14:17
- Terminology issues Helmut 2009-12-22 14:30
- Philostics ElMaestro 2009-12-27 00:47
- Philostics Helmut 2009-12-27 02:01
- Philostics ElMaestro 2009-12-27 13:28
- Philostics Helmut 2009-12-27 15:07
- Philostics ElMaestro 2009-12-28 02:46
- Philostics Helmut 2009-12-27 15:07
- Philostics ElMaestro 2009-12-27 13:28
- Philostics Helmut 2009-12-27 02:01
- Philostics ElMaestro 2009-12-27 00:47
- Terminology issues Helmut 2009-12-22 14:30
- Cmin (EU)d_labes 2010-01-04 10:45
- Repeated profiles Helmut 2010-01-04 13:53
- Cmin-value <LLOQ beman 2010-01-04 15:43
- Cmin-value <LLOQ Helmut 2010-01-04 16:34
- Cmin (EU) ElMaestro 2009-12-22 14:17