PK Vs Analytical [Bioanalytics]
❝ Am looking for a more specific way to determine linearity, from PK point of view,.....
I’m still not getting your point – maybe since your are posting in the ‘Bioanalytics’-category.
You should define a calibration function (which must not be linear, but describing a continous function of detector response from known concentrations) within LLOQ and ULOQ.
LLOQ and ULOQ are defined by PK requirements, whereas the calibration function depends on the analytical method.
❝ If we combined data in a "mathmatical equation" such as Absorption, excretion, inter-subject variabilty, Dose, rate of release in body......
❝ Can we finally have a Model that would give us a close estimation to what we usually end up by the end of the study.
❝ How far can we predict to what degree of details can we go....
That’s an endless story – for sure nothing to be explained in a couple of posts (many people devote their entire lifetimes on small fractions of these topics). I’ll give you some keywords:
- Biopharmaceutics Classification System (BCS)
- Biorelevant dissolution media
- In vivo – in vitro correlation (IVIVC)
- Population Pharmacokinetics (PopPK)
Anyhow, if you are in doubt whether your method is suitable, why don’t you opt for a small pilot study?
If the sponsor chooses, a pilot study in a small number of subjects can be carried out before proceeding with a full BE study. The study can be used to validate analytical methodology, assess variability, optimize sample collection time intervals, and provide other information.
Edit: FDA-link corrected to latest archived copy. [Helmut]
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Science Quotes
Complete thread:
- PK Vs Analytical Charl 2007-07-23 10:44 [Bioanalytics]
- PK Vs Analytical Helmut 2007-07-23 18:04
- PK Vs Analytical Charl 2007-07-24 10:31
- PK Vs AnalyticalHelmut 2007-07-24 13:42
- PK Vs Analytical Charl 2007-07-24 15:02
- PK Vs AnalyticalHelmut 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 Analytical Helmut 2007-07-23 18:04