Test samples expired for FED study [Regulatives / Guidelines]

posted by taiyab.jameel – India, 2020-03-05 10:02 (368 d 22:37 ago) – Posting: # 21205
Views: 4,634

Hello,

We have conducted Fasting BE study for Pantoprazole Sodium delayed release tablets from CRO.

As we are filing products in regulated market we have to performed Fed study as per EMEA & FDA guidelines.

Now problem is our Test samples are expired but RLD expiry renaming for next 8 months.

How can we conduct fed study. What are the challenges we can face after filing.

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