Bioequivalence and Bioavailability Forum

Dear Vismayi!

❝ In this study,we need to stabilize patients but for how many days neither it is mentioned in specific guidance nor product leaflet. So, what duration we should we consider for stabilization.

Generally patient are already on this medication. Stabilization periods means you have reached steady state with that formulation which generally takes about 3-5 half life of drug. Confirm after dosing for 3-5 halflife that C0 are constant. When changing the treatment, the same stabilization with new formulation needs to be applied.

❝ Beside,study product can be taken until patient tolerate as per leaflet.

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❝ If the disease pre-valence is less and this may lead to challenge in recruitment. So can we consider replicate design over conventional two-way.

If you are deviating from PSG- either design or healthy subject- kindly do CC with authority. Many a times, not even a single dose is re­comm­ended to HV.

Regards,
Divyen