Early exposure (+scaling?) [Nonparametrics]

posted by Helmut Homepage – Vienna, Austria, 2012-01-20 13:56 (4507 d 15:49 ago) – Posting: # 7978
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Dear Joshua!

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


IMHO FDA never asked for tmax. If clinically relevant ‘early exposure’ should be assessed (Guidance 2003, [image] 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.


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