Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RA community,

For NCE drug development everyone is familiar with ICH guidelines, and the need to conduct IND-enabling GLP repeat dose Tox studies in rodent and non-rodent species. 

However, for diabetes products for glycemic control what preclinical pharmacology and pharmacokinetic study requirements are required? Is there a certain guideline that can be referenced? Thank you.

See attachment. I hope this is useful.

------------------------------
Jean-Paul BRIFFAUX
Ronno
France
------------------------------

Original Message:
Sent: 03-Oct-2022 02:46
From: Anonymous Member
Subject: IND-enabling pre-clincial requirements for Diabetes drugs

This message was posted by a user wishing to remain anonymous

Dear RA community,

For NCE drug development everyone is familiar with ICH guidelines, and the need to conduct IND-enabling GLP repeat dose Tox studies in rodent and non-rodent species.

However, for diabetes products for glycemic control what preclinical pharmacology and pharmacokinetic study requirements are required? Is there a certain guideline that can be referenced? Thank you.

This message was posted by a user wishing to remain anonymous

Thankyou Jean-Paul. I am mainly looking for what IND-enabling animal PK/ADME/DDI studies are required. Thanks.
Original Message:
Sent: 04-Oct-2022 01:14
From: Jean-Paul BRIFFAUX
Subject: IND-enabling pre-clincial requirements for Diabetes drugs

See attachment. I hope this is useful.

------------------------------
Jean-Paul BRIFFAUX
Ronno
France

Original Message:
Sent: 03-Oct-2022 02:46
From: Anonymous Member
Subject: IND-enabling pre-clincial requirements for Diabetes drugs

This message was posted by a user wishing to remain anonymous

Dear RA community,

For NCE drug development everyone is familiar with ICH guidelines, and the need to conduct IND-enabling GLP repeat dose Tox studies in rodent and non-rodent species.

However, for diabetes products for glycemic control what preclinical pharmacology and pharmacokinetic study requirements are required? Is there a certain guideline that can be referenced? Thank you.

I don't think you will find a specific guidance for preclinical PK and PD studies that are "required" for a product for diabetes as a lot depends on the type of product and the mechanism of action. Rather I suggest that you review regulatory agency reviews of recent approvals for diabetes products to see what has been done. I suspect you will mostly find MOA and typical PK studies.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 03-Oct-2022 02:46
From: Anonymous Member
Subject: IND-enabling pre-clincial requirements for Diabetes drugs

This message was posted by a user wishing to remain anonymous

Dear RA community,

For NCE drug development everyone is familiar with ICH guidelines, and the need to conduct IND-enabling GLP repeat dose Tox studies in rodent and non-rodent species.

However, for diabetes products for glycemic control what preclinical pharmacology and pharmacokinetic study requirements are required? Is there a certain guideline that can be referenced? Thank you.

Similar position to Glen.
There are no specific regulatory guidances around nonclinical development for anti-diabetics.
Please refer to this interesting publication that gathers many investigational drugs for T2DM submitted to the FDA (Trends in Antidiabetic Drug Discovery: FDA Approved Drugs, New Drugs in Clinical Trials and Global Sales, Front Pharmacol. 2021; 12: 807548).

------------------------------
Christian Blot
Nonclinical Dossier Expert
France
------------------------------

Original Message:
Sent: 04-Oct-2022 08:17
From: Glen Park
Subject: IND-enabling pre-clincial requirements for Diabetes drugs

I don't think you will find a specific guidance for preclinical PK and PD studies that are "required" for a product for diabetes as a lot depends on the type of product and the mechanism of action. Rather I suggest that you review regulatory agency reviews of recent approvals for diabetes products to see what has been done. I suspect you will mostly find MOA and typical PK studies.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 03-Oct-2022 02:46
From: Anonymous Member
Subject: IND-enabling pre-clincial requirements for Diabetes drugs

This message was posted by a user wishing to remain anonymous

Dear RA community,

For NCE drug development everyone is familiar with ICH guidelines, and the need to conduct IND-enabling GLP repeat dose Tox studies in rodent and non-rodent species.

However, for diabetes products for glycemic control what preclinical pharmacology and pharmacokinetic study requirements are required? Is there a certain guideline that can be referenced? Thank you.