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RegisterConcentration Statistics - BQL substitution [General Statistics]
Dear Helmut and Sara,
In statistical language - values <LLOQ are informatively censored and ignoring this fact can lead to biased results.
Of course, adequate handling would require some modeling which seems to be in contradiction to regulatory thinking as NCA is clearly favored in BA/BE studies. However, I would like to bring a recent paper on this topic to your attention: Barnett H, Geys H, Jacobs T, Jaki T (2020). Methods for Non-Compartmental Pharmacokinetic Analysis with Observations below the Limit of Quantification. Statistics in Biopharmaceutical Research, 1-23
best regards & hope this helps
Martin
In statistical language - values <LLOQ are informatively censored and ignoring this fact can lead to biased results.
Of course, adequate handling would require some modeling which seems to be in contradiction to regulatory thinking as NCA is clearly favored in BA/BE studies. However, I would like to bring a recent paper on this topic to your attention: Barnett H, Geys H, Jacobs T, Jaki T (2020). Methods for Non-Compartmental Pharmacokinetic Analysis with Observations below the Limit of Quantification. Statistics in Biopharmaceutical Research, 1-23
best regards & hope this helps
Martin
Complete thread:
- Concentration Statistics - BQL substitution SaraCHenriques 2020-07-01 14:37 [General Statistics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Concentration Statistics - BQL substitution Helmut 2020-07-01 15:27
- Concentration Statistics - BQL substitutionmartin 2020-07-02 09:37
- Data imputation Helmut 2020-07-02 11:15
- Concentration Statistics - BQL substitution ElMaestro 2020-07-02 13:48
- Concentration Statistics - BQL substitution martin 2020-07-02 14:52
- Concentration Statistics - BQL substitution Ben 2020-07-07 16:37
- BQL in BE and PK modeling Helmut 2020-07-08 10:23
- Concentration Statistics - BQL substitution ElMaestro 2020-07-08 11:35
- Roger again mittyri 2020-07-08 12:03
- Concentration Statistics - BQL substitutionmartin 2020-07-02 09:37
- Concentration Statistics - BQL substitution Helmut 2020-07-01 15:27
Ing. Helmut Schütz