Bioequivalence and Bioavailability Forum

Dear Prakash
You will not find a guideline telling you the requested information. It is the responsibility of the sponsor to decide how to deal with it. The following answers are based on our procedures:

❝ 1. Number of investigational product to be required for retention?

=> sufficient for two full analyses

❝ 2. Duration until which the investigational products retention should be

❝ done?

=> 5 years

❝ 3. Responsibility of the retention of the investigational product. Sponsor

❝ or CRO ?

=> Sponsor/manufacturer
I hope this helps
Dan

---

Edit: Standard quotes restored. [Helmut]

Dear Prakash,

1. Sponsor can delegate CRO to keep retention and same should be mentioned in Protocol

2. Guideline is not clear as it is mentioning: "repeat the release test"... but the common practice is to keep retention enough to repeat in-vitro.

3. Keep the retention till approval to be on safer side; even after knowing the after expiry it is of no use to repeat the release test.

Hope is helps.

Hiren Mehta
TRC