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Back to the forum  Query: 2017-11-22 17:42 CET (UTC+1h)
 

Reference Listed Drug [Regulatives / Guidelines]

posted by ElMaestro - Denmark, 2017-04-19 09:43  - Posting: # 17252
Views: 904

Hi arpit.patel,

» Can we use difference batch of RLD in the single BE study.? Is there any guidance for such information.?

I have good experience with it (EU+US+Brazil). There are sometimes good reasons to do it, and sometimes no way around it. I am not aware of specific guidance.

I could be wrong, but…


Best regards,
ElMaestro

No, I still don't believe much in the usefulness of IVIVCs for OIPs when it comes to picking candidate formulations for the next trial. This is not the same as saying I don't believe in IVIVCs.

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