OEL Fastrac Catalog

Repaglinide is an oral nonsulfonylurea insulin secretagogue belonging to the meglitinide class with hypoglycemic activity. Repaglinide is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with type 2 diabetes mellitus whose hyperglycemia cannot be controlled satisfactorily by diet and exercise alone. In combination therapy with metformin, repaglinide is indicated to lower blood glucose in patients whose hyperglycemia cannot be controlled by diet and exercise, plus metformin monotherapy. In combination with rosiglitazone, repaglinide is indicated in patients who show intolerance to metformin or for whom metformin is contraindicated, when diet and exercise, plus rosiglitazone or repaglinide monotherapy do not result in adequate glycemic control.

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 Repaglinide, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.