Clarification: I guess I sort of skipped over the niacin mention. I agree that in this case with niacin being an active placebo, stability studies are required for the niacin content but 1 month stability data does not need to be submitted in the initial IND for FDA.
For placebos that are only the formulation of the investigational product with the active ingredient I do not do stability on the placebo and include something like the following statement in the IND:
The stability of excipients is well characterized, and the qualitative formulation composition and container closure system is the same as that of drug product. The stability program for the drug product includes evaluation of appearance, moisture content, disintegration/dissolution and is considered indicative of the stability of matching placebo tablets. We use the same expiry as the drug product.
------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------
Original Message:
Sent: 28-Mar-2022 18:15
From: Narayan Rao
Subject: IND Submission - Placebo - Section 3.2.P
I agree with the Anon's response above! You do need to place your placebo on stability program: 1) It appears that your clinical trial program requires a specific placebo formulated product 2) This formulated placebo containing Niacin, is your own formulation so definitely need stability data. In the US, we don't need an expiry date but a retest date for IMPDs either for an active dosage form or placebo such as this.
For an initial IND, just submit without the stability data but include initial testing results and as Anon above suggested, make a statement that concurrent stability data will be generated with the ongoing trial and will be submitted either as an information amendment or in the IND-AR
Good luck
PS: Reach out privately if you need any clarification.
------------------------------
GRSAOnline
Original Message:
Sent: 25-Mar-2022 10:31
From: Anonymous Member
Subject: IND Submission - Placebo - Section 3.2.P
This message was posted by a user wishing to remain anonymous
Your consultant is on right track! However, you don't need 30 day stability data for initial IND filing. make statement that it will be monitored concurrently and the updated data will be submitted either as information amendment or in the IND AR.
Original Message:
Sent: 25-Mar-2022 07:39
From: Anonymous Member
Subject: IND Submission - Placebo - Section 3.2.P
This message was posted by a user wishing to remain anonymous
Hello,
I am submitting an IND and we were told by a consultant to add another 3.2.P section for our placebo, since we are formulating our placebo. Our placebo is a combination of FDA approved Niacin and an FDA approved filler (i.e. Easytab). Because Niacin and Easytab are both accepted by the FDA, do I need to include an entire new 3.2.P? Our consultant mentioned because their is formulation occurring, we need a new 3.2.P section. The main concern is now needing 30 day stability for the placebo in order to submit the IND, let alone all of the paperwork involved.
I am not sure how other companies do it - buy a known placebo (i.e., Niacin) but have it match the exact same weight as your drug product?
Thank you for any insight