Bioequivalence and Bioavailability Forum • Cmin (story continued)

Cmin (story continued) [NCA / SHAM]

posted by Helmut – Vienna, Austria, 2011-09-15 16:37 (5026 d 11:46 ago) – Posting: # 7354
Views: 8,606

Γεια σου, Μαρσέλ!

❝ Another nightmare experience with Cmin.

As expected.

❝ How did you explain that Cmin is not a good metric to look at in your case?

Most importantly we gave a justification already in the protocol (which was accepted by the IEC and the German BfArM):

unethical; sample size 12 ⇒ 194 (see here),
no accumulation expected (simulated from the SD study to be 0.7%; see here),
in line with recent regulatory point of view (MD expected to be no more required if residual area in SD <20% of AUC_∞ and BE of C_last demonstrated; see here),
C_last considered unreliable (time deviations, missing samples); planned to use estimated C_min,τ instead, and
evaluation only exploratory.

BTW our simulation of accumulation from SD dose data turned out to be correct; we found 0.9% (test) and 1.0% (reference).
I will report here how the regulator(s) will like the study…

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

Cmin (story continued) Helmut 2011-06-22 17:03 [NCA / SHAM]
- Cmin (story continued) Marcel 2011-09-15 10:21
  - Cmin (story continued)Helmut 2011-09-15 14:37
    - Cmin (story continued) Marcel 2011-09-16 08:01
      - Cmin (cave: lengthy post) Helmut 2011-09-16 13:26
        
        Cmin (cave: lengthy post) Marcel 2011-09-20 08:33
        
        Cmin no more? Helmut 2011-09-20 10:08
        
        perspective from the PD world ElMaestro 2011-09-20 10:01
        
        perspective from the PD world Helmut 2011-09-20 10:20