Reference Listed Drug [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2011-05-11 13:59 (4705 d 20:44 ago) – Posting: # 7009
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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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