Bioequivalence and Bioavailability Forum

Metrics for multiple profiles [NCA / SHAM]

posted by Helmut  – Vienna, Austria, 2009-12-03 17:11 (5617 d 16:20 ago) – Posting: # 4423
Views: 11,632

Dear D. Labes!

❝ I love your always Solomonic answers!

Oh, not always! I can be quite strict - and even rude - sometimes...

❝ Is it your experience with the regulatory acceptance in doing so as you described?

Yes. But not fail-safe.

Just this week I saw an example what can go wrong. Nonlinear PK, three dose strengths, the highest strength cannot be administered in SD due to AEs. In a scientific advisory meeting in the RMS is was agreed to go with a dose-escalating study to steady steady state; %PTF primary rate parameter, C_max secondary. In the MRP one member state insisted in BE of C_min (which failed due to the high CV).

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


The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:

• Statistics in multiple dose study ratnakar1811 2009-12-01 11:09 [NCA / SHAM] 
  • Statistics in multiple dose study Helmut 2009-12-02 00:20
    • Statistics in multiple dose study ratnakar1811 2009-12-03 07:36
      • Statistics in multiple dose study Helmut 2009-12-03 14:53
        • Statistics in multiple dose study ratnakar1811 2009-12-04 08:21
    • Metrics for multiple profiles d_labes 2009-12-03 08:58
      • Metrics for multiple profiles Helmut 2009-12-03 15:50
        • Metrics for multiple profiles d_labes 2009-12-03 16:02
          • Metrics for multiple profilesHelmut 2009-12-03 16:11
        • PTF is another story d_labes 2009-12-03 16:17
          • PTF is another story Helmut 2009-12-03 16:42
            • the flatter is better? d_labes 2009-12-04 08:46
              • Biopharmaceutical history Helmut 2009-12-04 12:35