Bioequivalence and Bioavailability Forum

Hi Helmut,
thank you for your reply.
We have removed “magic” time allowance window (TAW) from our protocol. So every blood sampling deviation, will be reported in CRF and statistical analysis.

But one of our customer, ask us, to put TAW in our protocol. Since we can't justify the deviation, we can't accept the request. What I know from training, TAW will be specific for any kind of drug molecules, it can't 5%, more or less, depend on the impact to pharmacokinetic analysis.

But we don't how to decide the percentage of blood sampling deviation which can't make an effect to pharmacokintetic analysis.
Would you mind to share how to decide the percentage of blood sampling which can't categorize as deviation, so TAW won't be "magic" again, but scientifically sound.

Thank you
joy_fm