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Back to the forum  Query: 2018-04-26 11:37 CEST (UTC+2h)
 

Reference Listed Drug [Regulatives / Guidelines]

posted by ElMaestro - Denmark, 2017-04-19 09:43  - Posting: # 17252
Views: 1,618

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

- Bootstrapping for dissolution data is a relatively new hobby of mine.

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