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

posted by ElMaestro  – Denmark, 2018-09-20 12:19 (854 d 00:42 ago) – Posting: # 19294
Views: 1,430

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.

Pass or fail!
ElMaestro

Complete thread:

Activity
 Admin contact
21,308 posts in 4,444 threads, 1,489 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Thursday 12:02 CET (Europe/Vienna)

Politicians use statistics like drunkards use lampposts:
not for illumination, but for support.    attributed to Hans Kuhn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5