Bioequivalence and Bioavailability Forum

Dear Shabana!

❝ […] so washout will serve two purposes here - assure you that both PK and PD effects have worn off. So the IECs are not going to be happy only if you can show a reduction in "n", you also need to assure them that subjects will not be exposed to unnecessary risks, that their welfare is well taken care of, among other things. so when you say

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❝ ❝ ❝ How will you explain drug toxicity then???

❝ ❝ Simple: the concentration is above the toxicity level…

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❝ a CONCENTRATION above toxicity level is responsible for the observed toxicity. you have to assure them that the concentration does not go above toxicity. that is the trouble you may anticipate from IECs.

Again: Since we are talking about bioequivalence, highest concentrations are to be expected in the steady state profiles. It simply does not matter whether we apply a washout phase between treatment phases or not. So still I’m not getting your point about IECs.

❝ Nor do I advocate "additional washouts", as you put it. I say "judicious", one that will keep everyone involved happy. As for "uncomplicated drugs", as mentioned you have to demonstrate and justify that the effects are as you expect.

Full ACK!

P.S. Please avoid “TOFU” (see the Forum’s Policy)