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

posted by manusyriac – India, 2018-09-20 09:45 (890 d 14:06 ago) – Posting: # 19293
Views: 1,686

Hi All,

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.

Thank you.

Complete thread:

 Admin contact
21,357 posts in 4,459 threads, 1,492 registered users;
online 8 (0 registered, 8 guests [including 4 identified bots]).
Forum time: Friday 22:51 CET (Europe/Vienna)

Those who make no mistakes are making the biggest mistakes of all 
they are attempting nothing new.    Anthony de Mello

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