Regulatory Open Forum

Hi Meredith - Does the change meet the definition of a minor change in formulation? If so, I would think it could be non-glp as it is only a supplementary study and not required. However, it also seems like it could depend on the results - if your minor change resulted in a noticeable difference in the assay then you may have more work (GLP and CMC work) to do. If the change truly meets the minor category per FDA guidance, what is the reasoning for conducting the study? 

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Stephanie Markey
Associate Director
Fraser CO
United States
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Original Message:
Sent: 09-Feb-2024 07:00
From: Meredith Brown
Subject: question about mouse study conduct--GLP requirement?

Hello

I am seeking advice pertaining to mice studies.  We are looking at running an assay in a mouse model, and plan to share it with the FDA as part of an IND submission.  This is assay is being done to evaluate a minor change in manufacture of our product.  We are planning to request a pre-IND meeting soon. 

 

Does the mouse study need to be conducted GLP?

 

Thanks , Meredith

 

 

Meredith Brown, DVM, PhD

Preclinical Program Leader

Senior Research Scientist

 

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From what I understand (correct me If I am wrong), you wish to evaluate an assay that could potentially detect a change in product (i.e. pre-change vs. post change of product-I am assuming formulation change or some major change else you wouldn't be thinking of an INVIVO animal study?) using a mouse model, which I again assume disease model mouse. If this mouse model was used in the preclinical studies (i.e. IND enabling studies) to support your safety pharmacology/tox studies to support your FIH IND, then yes, it is recommended to be a GLP study! This is because you plan to use the same assay in the future for potential CMC related product changes and therefore my recommendation is a GLP study. You could ask for a waiver in your pre-IND meeting!

Reach out privately if you need help.

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GRSAOnline
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Original Message:
Sent: 09-Feb-2024 07:00
From: Meredith Brown
Subject: question about mouse study conduct--GLP requirement?

Hello

I am seeking advice pertaining to mice studies.  We are looking at running an assay in a mouse model, and plan to share it with the FDA as part of an IND submission.  This is assay is being done to evaluate a minor change in manufacture of our product.  We are planning to request a pre-IND meeting soon. 

 

Does the mouse study need to be conducted GLP?

 

Thanks , Meredith

 

 

Meredith Brown, DVM, PhD

Preclinical Program Leader

Senior Research Scientist

 

The content of this email is confidential, may contain trade secrets, and is intended for the recipient specified in message only. It is strictly forbidden to share any part of this message with any third party, without a written consent of the sender. If you received this message by mistake, please reply to this message and follow with its deletion, so that we can ensure such a mistake does not occur in the future.

Good morning Meredith.

How much preclinical work have you already done? If you have GLP toxicology studies in hand, yes, you should do this study as GLP. If you have not yet done GLP tox studies, I refer you to Stephanie Markey's response about the definition of minor change. Is the change in the API or the formulation of the final product? Do analytical results show a significant difference from the pre-change material? Assuming you have not yet done GLP tox studies, is there a reason analytical results cannot be used to evaluate the impact of the change?

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Arvilla Trag RAC
Principal Consultant
CMC Compliance Services
Iron River MI
United StatesCMC Compliance Services LLC
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Original Message:
Sent: 09-Feb-2024 07:00
From: Meredith Brown
Subject: question about mouse study conduct--GLP requirement?

Hello

I am seeking advice pertaining to mice studies.  We are looking at running an assay in a mouse model, and plan to share it with the FDA as part of an IND submission.  This is assay is being done to evaluate a minor change in manufacture of our product.  We are planning to request a pre-IND meeting soon. 

 

Does the mouse study need to be conducted GLP?

 

Thanks , Meredith

 

 

Meredith Brown, DVM, PhD

Preclinical Program Leader

Senior Research Scientist

 

The content of this email is confidential, may contain trade secrets, and is intended for the recipient specified in message only. It is strictly forbidden to share any part of this message with any third party, without a written consent of the sender. If you received this message by mistake, please reply to this message and follow with its deletion, so that we can ensure such a mistake does not occur in the future.