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

posted by manusyriac – India, 2018-09-20 09:45 (1429 d 00:41 ago) – Posting: # 19293
Views: 1,845

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
22,305 posts in 4,668 threads, 1,587 registered users;
online 6 (0 registered, 6 guests [including 4 identified bots]).
Forum time: Friday 10:26 CEST (Europe/Vienna)

Doctors are men who prescribe medicines of which they know little,
to cure diseases of which they know less,
in human beings of whom they know nothing.    Voltaire

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