Aber meine Dame, das ist alles Unsinn! [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2020-06-08 01:04 (173 d 00:09 ago) – Posting: # 21507
Views: 4,989

Hi Nastia,

» Do you know a legend about Ehrenfest's parrot?

Yes. Do you know Wigner’s friend?

» I wish I have that parrot to say: "Aber meine Herren das ist keine Wissenschaft!" every time I get the request to use 80% rule :-D


» By the way is not it similar to one used in 1997 by Endrenyi L. et al*?

Yes and no. There are many papers about partial AUCs but most of them deal with early exposure. That’s not what I’m interested in. BTW, a plot of Mei-Ling’s paper1 shows also that the CV decreases with time. OK, little bit unfair. Not with time itself but with median tmax, where pAUC0–ref,tmax.


A small case study2 shows also the high variability of pAUC0–ref,tmax.

» As far as I know the war almost starts when russian experts try to translate this word properly. For me "должно быть" sounds like an order.

Shall I say I expected that?

» ("Marain was a synthetic language, designed to be phonetically and philosophically as expressive as the pan-human speech apparatus and the pan-human brain would allow")

Great! Do you know Volapük?

» I often deal with protocols where the definition of AUC is ambiguously: in the one part of the protocol they are talking about AUC0–72 and in the other - about AUC0–t (AUClast).

Shit. That’s why I give in my protocols even a plot to show how I deal with cut-off times…

» About AUC0–t (AUCall) see also Oishi M. et al.

Funny abstract. Can you send me a copy?

  1. Chen M-L, Davit B, Lionberger R, Wahba Z, Ahn H-Y, Yu LX. Using Partial Area for Evaluation of Bioavailability and Bioequivalence. Parm Res. 2011;28(8):1939–47. doi:10.1007/s11095-011-0421-x.
  2. Najib NM, Salem I, Hasan R, Idkaidek NM. Effect of Truncated AUC Method on Drug Bioequivalence in Humans. J Bioequiv Bioavail. 2009;1(4):112–4. doi:10.4172/jbb.1000017. [image] Open access.

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Helmut Schütz

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