Bioequivalence and Bioavailability Forum

A Nightmare on Elm Street [Study Per­for­mance]

posted by jag009  – NJ, 2013-09-13 17:26 (4666 d 11:17 ago) – Posting: # 11491
Views: 12,122

❝ So in the protocol they simply copypasted from the guidance “AUC_0-4, AUC_4-t, AUC_0-∞, and C_max, where AUC_0-4 is the area under the plasma-concentration vs. time curve from 0 to 4 hours, AUC_4-t is area under the curve from 4 hours to the last measurable time point” without stating the algo? Brilliant. Which software are they using?

Exactly... Software wise I think they use both WinNonlin and SAS. I think they can do the interpolation by doing a protocol amendment? I have seen this before and FDA accepted it (not for partial AUC but for other things).
A lot of companies do this because they don't know whether their Kel elimination coding in SAS is "safe" so they need something that is officially validated.

❝ ❝ They have the following:

❝ ❝ 3.5 hr with a time deviation of 45 mins; Reason - Restick

❝ ❝ 4 hr with a time deviation of 15 mins; Reason - Restick

❝

❝ Splendid. As you posted before I thought I have seen everything – but this?!

YES! I told you I haven't seen EVERYTHING

❝ The latter (OK, the second one at 4:15). Set the first one to “missing”, “not reportable“, or “oops”.

Why the latter and not the first? If they have both samples and the numbers are different? I think they should take the average?

Thanks
John

Complete thread:

• Boneheads! jag009 2013-09-09 21:12 [Study Per­for­mance] 
  • WTF ? Ohlbe 2013-09-09 21:26
    • Snafued! Helmut 2013-09-09 21:55
      • Snafued! WTF! &%$@! jag009 2013-09-10 16:11
        • pAUCs Helmut 2013-09-11 21:01
          • pAUCs - the SEQUEL jag009 2013-09-12 20:48
            • A Nightmare on Elm Street Helmut 2013-09-13 00:55
              • A Nightmare on Elm Streetjag009 2013-09-13 15:26
                • A Nightmare on Elm Street Helmut 2013-09-13 16:00
                  • A Nightmare on Elm Street jag009 2013-09-13 19:57
    • WTF ? jag009 2013-09-10 16:13
      • monitor ElMaestro 2013-09-10 18:31
        • monitor jag009 2013-09-10 22:48