OEL Fastrac Catalog

Omarigliptin is a novel dipeptidyl peptidase 4 (DPP4)-inhibitor indicated in the treatment of type 2 diabetes mellitus (T2DM). The incretin hormones, glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the gut in response to food intake and an increase in blood glucose. These hormones stimulate insulin secretion in a glucosedependent manner. Additionally, GLP-1 has been shown to inhibit glucagon release and decrease in gastric emptying. In rodent studies, it promotes the regeneration and differentiation of islet β-cells. However, GLP-1 is not a stable peptide and is cleaved rapidly to its inactive form by DPP-4. Inhibition of DPP-4 prolongs the circulating half-life of glucagonlike peptide 1 and glucose-dependent insulinotropic polypeptide. By increasing the circulating concentration of GLP-1 and GIP, DPP-4 inhibitors improve glucose control in patients with type 2 diabetes.

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.

Why do you need this OEL Fastrac monograph?

OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Omarigliptin, just click the ADD TO CART button.

HBEL

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