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RegisterRelatorio estatistico [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2022-07-13 13:02 (1030 d 22:03 ago) – Posting: # 23136
Views: 5,503
Dear Ohlbe,
Kudos! May I call you Sherlock in the future?
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
Quoting Gabrielsson and Weiner:2
In this goodie only nominal time as well. In Pharmacokinetic Parameters
❝ […] 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.
In this goodie only nominal time as well. In Pharmacokinetic Parameters
AUCINF_obs. - Hauschke D, Steinjans V, Pigeot I. Bioequivalence Studies in Drug Development. Methods and Applications. Chichester: Wiley; 2007. p. 131.
- Gabrielsson J, Weiner D. Pharmacokinetic and Pharmacodynamic Data Analysis. Concepts and Applications. Stockholm: Apotekarsocieteten; 5th ed. 2016. p. 147.
—
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Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- schedule time vs. actual time for ANVISA BE Shuanghe 2022-07-10 00:36
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- schedule time for ANVISA? Helmut 2022-07-10 15:37
- schedule time vs. actual time for ANVISA BE Relaxation 2022-07-12 13:50
- Not even wrong Helmut 2022-07-12 16:15
- Not even wrong Shuanghe 2022-07-13 15:23
- ANVISA: MD studies no more required Helmut 2022-07-13 17:03
- Not even wrong Shuanghe 2022-07-13 15:23
- Relatorio estatistico Ohlbe 2022-07-13 10:23
- Relatorio estatisticoHelmut 2022-07-13 11:02
- ANVISA Ohlbe 2022-07-13 12:37
- ANVISA Helmut 2022-07-13 17:17
- Relatorio estatistico pjs 2022-07-25 10:42
- Full book? Helmut 2022-07-25 12:32
- ANVISA Ohlbe 2022-07-13 12:37
- Relatorio estatisticoHelmut 2022-07-13 11:02
- schedule time vs. actual time for ANVISA BE Shuanghe 2022-07-13 15:21
- Not even wrong Helmut 2022-07-12 16:15
- schedule time vs. actual time for ANVISA BE ElMaestro 2022-07-12 23:10
- TPD? Helmut 2022-07-12 23:29
- schedule time vs. actual time for ANVISA BE Shuanghe 2022-07-13 15:15
- schedule time vs. actual time for ANVISA BE ElMaestro 2022-07-14 14:57
Ing. Helmut Schütz