Bioequivalence and Bioavailability Forum

Dear Elmaestro,

First of all thanx for your prompt response.

❝ could you please tell a lot more about the product:

One product is modified release oral solid and another one is transdermal patch.

❝ Are you aiming toget a approval for a delivery system with or without drug integrated?

We are targeting to get approval only for delivery system. Drug is already available as generic.

❝ Where (EU, US, India, ...?)?

It will be very appreciable if you elaborate requirements for all markets mentioned above.

❝ What is the nature of this system?

1) Extended release tablets 2) Transdermal patches.

❝ Is the delivery local or systemic?

One systemic and another one is local.


Best Regards,
Swapnil