Reactive oxygen species - Safety testing
3 important questions on Reactive oxygen species - Safety testing
What should you consider in safety testing?
Reactive metabolites.
- human in vitro studies relevant for human drug safety ?
- human metabolites seen in animal studies ?
- quantification RMs ? -
- location of RMs (not stable enough for transport) ?
- -idiosyncratic (rare) toxicities often related to RMs !
- - possible involvement immune system !
Because toxicity assays have limitations, what do we need? And what is often tested?
Integrated risk assessments.
If something is covalently bound.
- You have your drug and you label it. Non covalent drug in supernatant. Incubate cells (liver for metabolic activity). Separate the protein, labeled drugs from non labeled drug.
If something is covalently bound.
- You have your drug and you label it. Non covalent drug in supernatant. Incubate cells (liver for metabolic activity). Separate the protein, labeled drugs from non labeled drug.
Is it enough if you know a drug is not binding covalently?
No, the dose is also important.
But also the dose is not a guarantee.
It is the best to do an integrated approach. With cellulair toxicity assays and covalent binding. Also different type of cells.
But also the dose is not a guarantee.
It is the best to do an integrated approach. With cellulair toxicity assays and covalent binding. Also different type of cells.
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