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

posted by manusyriac – India, 2018-09-20 09:45 (968 d 07:04 ago) – Posting: # 19293
Views: 1,712

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.

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