Bioequivalence and Bioavailability Forum • Usage of different lots of RLDs in multistage adaptive studies

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

posted by manusyriac – India, 2018-09-20 11:45 (2832 d 18:55 ago) – Posting: # 19293
Views: 3,716

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:

Usage of different lots of RLDs in multistage adaptive studiesmanusyriac 2018-09-20 09:45
- Usage of different lots of RLDs in multistage adaptive studies ElMaestro 2018-09-20 12:19
  - Usage of different lots of RLDs in multistage adaptive studies manusyriac 2018-09-20 13:05