OEL Fastrac Catalog

Daprodustat is a small-molecule hypoxia-inducible factor (HIF) prolyl hydroxylase (PHD) inhibitor. In June 2020, daprodustat was first approved in Japan for the treatment of renal anemia for patients both on and off dialysis. On October 2022, the Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) supported the idea that the benefit of treatment with daprodustat outweighs the risks for adult dialysis patients with anemia of chronic kidney disease (CKD) but not for nondialysis patients with anemia of CKD. On February 1, 2023, daprodustat was fully approved by the FDA as the first oral treatment for anemia caused by CKD in patients on dialys.

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 Daprodustat, just click the ADD TO CART button.

HBEL

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