Relatorio estatistico [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2022-07-13 13:02 (198 d 10:26 ago) – Posting: # 23136
Views: 1,477

Dear Ohlbe,

❝ […] I managed to find …


Kudos! May I call you Sherlock in the future?

❝ … that document. Latest version is 2.0, dated 09/09/2015.


On top of the page: “Atualizado em 11/11/2020 14h43”

Interesting that no formula is given for the extrapolation.
In previous guidelines it was \(\small{AUC_{0-\infty}=AUC_{0-\text{last}}+C_{t_\text{last}}/\widehat{\lambda}_\text{z}}\). Since Hauschke et al.1 is in the references, may we use the recommended \(\small{AUC_{0-\infty}=AUC_{0-\text{last}}+\widehat{C}_{t_\text{last}}/\widehat{\lambda}_\text{z}}\) (in Phoenix parlance AUC_INFpred instead of AUCINF_obs)?
Quoting Gabrielsson and Weiner:2

In general, we recommend use of the predicted rather than the observed
last concentration when computing the extrapolated area.

See also this article.

In this goodie only nominal time as well. In Pharmacokinetic Parameters AUCINF_obs:-(


  1. Hauschke D, Steinjans V, Pigeot I. Bioequivalence Studies in Drug Development. Methods and Appli­ca­tions. Chichester: Wiley; 2007. p. 131.
  2. Gabrielsson J, Weiner D. Pharmacokinetic and Pharmacodynamic Data Analysis. Concepts and Appli­ca­tions. Stock­holm: Apote­kar­­so­ci­eteten; 5th ed. 2016. p. 147.

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