Bioequivalence and Bioavailability Forum • Reference Listed Drug

Reference Listed Drug [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2011-05-11 13:59 (5526 d 07:28 ago) – Posting: # 7009
Views: 8,588

Dear Kiran!

❝ Is there any guidance for the same or it is just a practice?

No guidance I know of. But you already justified it in your first post:

❝ due to unavailabilty of same batch of RLD used for fasting study.

Of course its desirable to have the same batches (in order to perform a between studies comparison); especially for blockbusters it's unlikely that you get the same batch even after a couple of months. If you are lucky and more than one batch is on the market, try to make a selection matching the first batch (content, dissolution).

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Helmut Schütz

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Complete thread:

Reference Listed Drug kiranActimus 2011-05-11 10:36
- Reference Listed Drug Helmut 2011-05-11 11:35
  - Reference Listed Drug kiranActimus 2011-05-11 11:50
    - Reference Listed DrugHelmut 2011-05-11 11:59
      - Reference Listed Drug kiranActimus 2011-05-11 12:12
        
        Reference Listed Drug luvblooms 2011-06-01 09:30
      - Reference Listed Drug arpit.patel 2017-04-19 06:04
        
        Reference Listed Drug ElMaestro 2017-04-19 09:43