Bioequivalence and Bioavailability Forum

AUC * k [NCA / SHAM]

posted by Helmut  – Vienna, Austria, 2021-10-01 19:01 (535 d 15:04 ago) – Posting: # 22612
Views: 1,652

Dear Detlew,

❝ what do you think is a reasonable assumption about the distribution of the metric AUC*k?

Since both are lognormal, their ratio should be lognormal as well. I trust here Martin; will meet him in the evening and ask again. Furthermore, the distribution of values per se is not important, only the residual error.

One of my 4-period full replicate studies (143 subjects, Method A)

❝ Do we have to throw away our evaluation of BE studies assuming log-normal distri of the metrics AUC and/or Cmax?

Not at all – if they passed.  Too bad if they failed and would have passed with AUC·k…

—
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:

• AUC · k for variable inter-occasion CL Helmut 2021-09-30 23:31 [NCA / SHAM] 
  • AUC · k for variable inter-occasion CL PharmCat 2021-10-01 00:15
    • Changing the regulations: Hope dies last. Helmut 2021-10-01 11:18
      • AUC * k d_labes 2021-10-01 13:52
        • AUC * kHelmut 2021-10-01 17:01
          • AUC * k d_labes 2021-10-02 10:55
            • Ratio/product of two lognormals Helmut 2021-10-03 20:29
            • Not for HVDPs? Helmut 2021-10-04 12:05
              • what about recyclers? mittyri 2021-10-04 14:22
                • Oh dear! Helmut 2021-10-04 16:10
      • Changing the regulations: Hope dies last. PharmCat 2021-10-01 18:48