Bioequivalence and Bioavailability Forum

Dear RK,

❝ I applied Test license for some X drug in India, I got permission and I imported the drug (reference) from outside India then conducted one study (pilot). Now I want to conduct one more study (pivotal) with remaining quantity of Reference drug from first study. Here I have some doubts:

❝ 1) Can I use remaining quantity of reference drug for pivotal

No, You can't use the rest of the reference drug for conducting a BE Study with a new ordered reference drug batch, as they are two different Batches (Biobatches).

❝ 2) If we use remaining IPs, Is we need to get Test license permission for pivotal.

Yes, you will need.

Regards,

Osama