No, you don't need to include the results of studies of analogs in the IB. If both products proceed down an IND path, you wouldn't need to include both products in both IBs. At some point, you may need to talk about class effects, and if you did study them together as a combination under IND then of course you would include information on both products, separately and together.
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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
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Original Message:
Sent: 13-May-2019 14:11
From: Anonymous Member
Subject: Pre-clinical study with a structural analog
This message was posted by a user wishing to remain anonymous
Hello,
We have an active IND for one of our investigational product (let's say Product X) and investigator brochure (IB) is up-to-date for that program(Product X).
My question is if we do additional pre-clinical studies with a structural analog of Product X (mono or combination therapy) and not necessarily with the investigational Product X, then do we have to list these studies and the findings in the Product X's IB.
Thank you!!