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

posted by manusyriac – India, 2018-09-20 11:45 (2016 d 04:28 ago) – Posting: # 19293
Views: 2,073

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:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,638 registered users;
80 visitors (0 registered, 80 guests [including 13 identified bots]).
Forum time: 15:13 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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