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Hi Everyone,
Do you have experience wherein none of the Primary stability batches (for NDA) were used in the clinic, for phase 2 or 3 clinical trial material?
--i.e. the batch used for clinical trials was manufactured at site 1, which is different from DP manufacturing site for primary stability batches (site 2).
Appreciate your thoughts on justifying the lack of any clinical experience with primary stability batches, and what comparative data would be sufficient?
This is for oral dosage form, BCS 1. No changes for drug substance between clinical batch and primary stability batch.
I ask because FDA/regulators are increasingly interested in clinically relevant specs (release and expiry/shelf-life).