Bioequivalence and Bioavailability Forum

Early exposure (+scaling?) [Nonparametrics]

posted by Helmut  – Vienna, Austria, 2012-01-20 13:56 (5260 d 03:05 ago) – Posting: # 7978
Views: 18,396

Dear Joshua!

❝ Thank you so much for your reply. I was actually referring to the USFDA.

IMHO FDA never asked for t_max. If clinically relevant ‘early exposure’ should be assessed (Guidance 2003, Section III.A.8.a.):

[…] the guidance re­com­mends use of partial AUC as an early exposure measure. We re­com­mend that the partial area be truncated at the population median of Tmax values for the re­fe­rence formulation. We also recommend that at least two quantifiable samples be collected be­fore the expected peak time to allow adequate estimation of the partial area.

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


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Science Quotes

Complete thread:

• Tmax in Partial Replicate Design Joshua 2012-01-17 06:59 
  • Good question! Helmut 2012-01-17 11:34
    • Good question! Joshua 2012-01-20 11:54
      • Early exposure (+scaling?)Helmut 2012-01-20 12:56
  • Tmax in Partial replicate design d_labes 2012-01-20 11:12
    • Tmax in Partial replicate design Joshua 2012-01-20 12:09
      • Intra-subject contrast (difference) d_labes 2012-01-20 12:55
        • Intra-subject contrast (difference) Joshua 2012-01-20 13:01
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    • Tmax in Partial replicate design mittyri 2017-01-03 23:24
      • ISC and Wilcoxon signed rank test d_labes 2017-01-04 10:21
        • ISC and Wilcoxon signed rank test in coin package mittyri 2017-01-04 14:17
          • ISC and Wilcoxon signed rank test in coin package d_labes 2017-01-04 16:09