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RegisterExclusion of subject from the calculation of AUCinf [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2011-08-03 15:55 (5445 d 18:47 ago) – Posting: # 7254
Views: 5,270
Dear Ratnakar!
If it was stated in the protocol, yes (see the section of the GL you quoted already). If not, present a sensitivity analysis (i.e., with and without the subject). Remember that you don’t have to exclude all of the subject’s data, only AUC! You still may use his/her Cmax. Since generally the sample size of BE studies are based on the (higher variable) Cmax, I wouldn’t worry too much about loosing a little bit power of AUC.
This is only a reminder that extrapolated AUC is of no importance if AUC truncated at 72h (AUC(0-72h)) was the main metric for extent of absorption according to protocol (see the GL Section 4.1.5).
❝ This is regarding the exclusion of subject from the calculation of AUCinf, in a study one of the subject did not arrive for any of the ambulatory sample (3 samples till 96 hr post dose) because of which AUC inf could not be calculated reliably (AUC% extrapolated was about 68%), in this situation can we exclude the subject with the justification?
If it was stated in the protocol, yes (see the section of the GL you quoted already). If not, present a sensitivity analysis (i.e., with and without the subject). Remember that you don’t have to exclude all of the subject’s data, only AUC! You still may use his/her Cmax. Since generally the sample size of BE studies are based on the (higher variable) Cmax, I wouldn’t worry too much about loosing a little bit power of AUC.
❝ Further what does the last sentence signifies, "This does not apply if the sampling period is 72 h or more and AUC(0-72h) is used instead of AUC(0-t)."
This is only a reminder that extrapolated AUC is of no importance if AUC truncated at 72h (AUC(0-72h)) was the main metric for extent of absorption according to protocol (see the GL Section 4.1.5).
—
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Helmut Schütz
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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:
- Exclusion of subject from the calculation of AUCinf ratnakar1811 2011-08-03 07:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Exclusion of subject from the calculation of AUCinfHelmut 2011-08-03 13:55
- Exclusion of subject from the calculation of AUCinf ratnakar1811 2011-08-04 08:51
- Exclusion of subject from the calculation of AUCinf Helmut 2011-08-04 11:09
- Exclusion of subject from the calculation of AUCinf ratnakar1811 2011-08-04 14:58
- Exclusion of subject from the calculation of AUCinf Helmut 2011-08-05 10:38
- Exclusion of subject from the calculation of AUCinf ratnakar1811 2011-08-06 09:34
- Exclusion of subject from the calculation of AUCinf Helmut 2011-08-05 10:38
- Exclusion of subject from the calculation of AUCinf ratnakar1811 2011-08-04 14:58
- Exclusion of subject from the calculation of AUCinf Helmut 2011-08-04 11:09
- Exclusion of subject from the calculation of AUCinf ratnakar1811 2011-08-04 08:51
- Exclusion of subject from the calculation of AUCinfHelmut 2011-08-03 13:55
Ing. Helmut Schütz