T7: toxicokinetics
8 important questions on T7: toxicokinetics
How does drug elimination look like?
What is a PBPK model?
With this you can predict and estimate the drug circulation in the body in different compartments.
What do you need for a PBPK model?
physiological parameters
chemical parameters
kinetic constants (in vitro)
output:
model prediction for levels relevant metabolites
- at different oral doses
- in different species
- in different organs
- in different individuals
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What are the advantages of a PBK Model?
Physiologically based kinetics model:
- provide the time course of distribution to any organ or tissue
- allow estimations of the effect of changing physiological parameters
- model can predict differences in toxicokinetics between species
- different dosing regimes are easily accommodated; allow high to low dose extrapolation.
What is regulatory testing, and why testing?
Acceptable daily intake: ADI
Tolerable daily intake: TDI
A test can also be done to test for danger so that a label can be put on the product, classification and labelling.
How to analyze a dataset?
Then you get NOAEL and LOAEL:
NOAEL: No-Observed averse effect level --> the highest concentration that does not differ from control. Depending on the study design!
LOAEL: Lowest observed effect adverse level --> the lowest concentration that does differ significantly.
Another way to analyze a data set is?
Here you get terms like EC10 and EC50. This means that you can calculate at what concentration the effect is 10%, or 50%
What are the advantages of the BMD approach?
- It is independent of choice of exposure.
Cons are:
- you have to define the effect upfront and this could be difficult especially in low quantaties.
The question on the page originate from the summary of the following study material:
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