Bioequivalence and Bioavailability Forum

Dear Tal!

❝ Is it possible to complete the bioanalytical method validation, during the dosing period of a study?

I would strongly recommend not to start this game. After method development you perfom the valida­tion, but: though your method might be validated – it is always possible that it suggests not valid results. In such a case you have to go back one step and modify the method.

❝ and of course to comply to the rule that bioanalytical work on the blood samples will not start before validation is completed?

What if you find problems with freeze thaw cycles or long term stability? Imagine a situation where you find out that your samples have to be stored at -70 ℃ and analysed within four weeks. But your samples already sit in the freezer at -20 ℃ waiting for the validation to complete…

For a BE study therefore I would avoid this situation. For other types of PK studies (where samples are analysed in batches for months) it is not uncommon to update long term stability regularily. But again, I wouldn’t start the clinical part before I have a validated (=suitable for use) method.