Relatorio estatistico [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2022-07-13 13:02 (144 d 00:46 ago) – Posting: # 23136
Views: 1,245

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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
 Admin contact
22,428 posts in 4,694 threads, 1,598 registered users;
16 visitors (0 registered, 16 guests [including 9 identified bots]).
Forum time: 12:48 CET (Europe/Vienna)

Operational hectic replaces
intellectual calms.    Alexander Huiskes

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz