Bioequivalence and Bioavailability Forum • Reference Listed Drug

Reference Listed Drug [Regulatives / Guidelines]

posted by kiranActimus – India, 2011-05-11 12:36 (4730 d 20:26 ago) – Posting: # 7004
Views: 7,861

Dear All

Please suggest me whether we can do Fasting and Fed BE Studies of same Molecule with two different batches of RLD?

We have conducted fasting pivotal study with one batch of reference product but our client want to go with a different batch of reference product for the fed pivotal study due to unavailabilty of same batch of RLD used for fasting study.

Please advise will the studies be acceptable by the US FDA?

Thanks in advance.

Regards
Kiran

Complete thread:

Reference Listed DrugkiranActimus 2011-05-11 10:36 [Regulatives / Guidelines]
- Reference Listed Drug Helmut 2011-05-11 11:35
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