Bioequivalence and Bioavailability Forum

Dear All,

I had carried out a cross over study for Health Canada regulatory. After completion of the study, I had reconciled remaining IPs and stored the same in storage cabinets after sponsor approval.

After few months sponsor sent me another shipment of IPs of same batch/ lot and asked me to merge this samples with retention samples of previous study.

This is all to carry out steady state study for Health canada regulatory.

After few months, due to some reasons, study was not performed and IPs got expired.

My question is what should i do with this IPs.
1. Return all IPs to sponsor.
2. Remain All the samples after seeking approval from sponsor to consider all IPs as a retention sample for previous study

I will choose second option. Please reply.

Regards,
anky1212