Bioequivalence and Bioavailability Forum

Cmin (EU) [Surveys]

posted by d_labes  – Berlin, Germany, 2010-01-04 11:45 (5644 d 16:15 ago) – Posting: # 4555
Views: 14,130

Dear Helmut,

Ad 1)

❝ How do you define C_min in steady state?

1.a) as standard, 1.a) or 1.c) as option
Ad 1e)

❝ Additional question: your rationale for either of the above

for 1.a) Common sense (what is a minimum?), ease of calculation and consistency (same value used for other parameters like swing or PTF)
for 1.a) or 1.c) Sponsor's wish

Ad 2)

❝ Do you only report values for the formulations (geometric mean, sd) ...

It depends (not at least on sponsor's wish ).

Ad 3)

❝ If the latter, do you use the metric in a confirmatory analysis (e.g., state an acceptance range)? ...

See ad 2)
Never used 3.c)
Acceptance range usually 0.8-1.25, but also widening.

Ad 4)

❝ Did you have any problems with your approach?

No problems so far for the definition of Cmin (regardless of which).
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 ...

None due to rare use of steady state studies.

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 [Surveys] 
  • 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
  • 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