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RegisterPK Vs Analytical [Bioanalytics]
posted by Helmut 
– Vienna, Austria, 2007-07-23 20:04 (6496 d 15:23 ago) – Posting: # 926
Views: 12,472
Dear Charl!
That’s the only way to do it (we had this already)!
Analytics is just a tool serving PK. You must cover the entire range from the highest Cmax observed in any of the subjects to a suitable LLOQ (covering 80% of AUC∞ in the subject with the lowest levels).
The upper range is not so critical, because you may dilute samples above the ULOQ and re-analyse them. Of course the dilution step must be validated.
In BE linearity generally is not that critical, but in PK (e.g., multi-phasic models after an i.v. administration) sometimes it may be rather tough due to limited detector linearity in MS and fluorescence.
Sure, the PK-people should tell you what concentrations they expect in the study.
They may refer to previous studies, literature, or PK-simulations…
❝ what is the best way to decide on the LLOQ depending on pharmacokinetics point of view, rather than depending on the analytical parameters to decide?
That’s the only way to do it (we had this already)!
❝ Is there a proper way to estimate the linearity range from PK data rather than analytical approach?
Analytics is just a tool serving PK. You must cover the entire range from the highest Cmax observed in any of the subjects to a suitable LLOQ (covering 80% of AUC∞ in the subject with the lowest levels).
The upper range is not so critical, because you may dilute samples above the ULOQ and re-analyse them. Of course the dilution step must be validated.
In BE linearity generally is not that critical, but in PK (e.g., multi-phasic models after an i.v. administration) sometimes it may be rather tough due to limited detector linearity in MS and fluorescence.
❝ My point can we work on the analytical method development depending on the PK and statistical output to design our analytical method? 
Sure, the PK-people should tell you what concentrations they expect in the study.
They may refer to previous studies, literature, or PK-simulations…
—
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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. 🚮
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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:
- PK Vs Analytical Charl 2007-07-23 10:44 [Bioanalytics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- PK Vs AnalyticalHelmut 2007-07-23 18:04
- PK Vs Analytical Charl 2007-07-24 10:31
- PK Vs Analytical Helmut 2007-07-24 13:42
- PK Vs Analytical Charl 2007-07-24 15:02
- PK Vs Analytical Helmut 2007-07-24 13:42
- PK Vs Analytical Charl 2007-07-24 10:31
- PK Vs Analytical drshiv 2007-07-31 08:47
- PK Vs Analytical Charl 2007-07-31 14:07
- PK Vs Analytical drshiv 2007-08-07 16:37
- NCA 'model independent'? Helmut 2007-08-11 20:09
- NCA 'model independent'? drshiv 2007-08-12 13:08
- Numerical integration Helmut 2007-08-12 18:51
- Numerical integration drshiv 2007-08-14 08:29
- Numerical integration Helmut 2007-08-12 18:51
- NCA 'model independent'? drshiv 2007-08-12 13:08
- NCA 'model independent'? Helmut 2007-08-11 20:09
- PK Vs Analytical drshiv 2007-08-07 16:37
- PK Vs Analytical Charl 2007-07-31 14:07
- PK Vs AnalyticalHelmut 2007-07-23 18:04
Ing. Helmut Schütz