Usage of different lots of RLDs in multistage adaptive studies [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2018-09-20 12:19 (772 d 11:11 ago) – Posting: # 19294
Views: 1,407

Hi manusyriac,

» Can we use different lots of RLDS in multistage studies as the study design requires more than 2 years of shelf-life for RLDs. If it is possible please help me to find any relevant regulatory guidance for the same.

Without being absolutely sure I think this would be ok with most EU authorities for the reasons you state. Less convinced about how HC or FDA or PMDA would see it.
Note that in your case batch and stage will have the same meaning for the product(s) in question.

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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