OEL Fastrac Catalog

Vadadustat is an oral hypoxia-inducible factor prolyl-hydroxylase (HIF-PH) inhibitor used to treat symptomatic anemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis. Vadadustat is an inhibitor of HIF-PH, that facilitates increased hypoxia-inducible factor (HIF) activity in the absence of hypoxic conditions. Hypoxia-inducible factors (HIFs) are transcription factors responsible for cellular survival under hypoxic conditions. They regulate a number of processes including angiogenesis, cell growth and differentiation, various metabolic processes, and erythropoiesis. Under normoxic conditions, HIFs are degraded via hydroxylation by prolyl-hydroxylase dioxygenases. The increased levels of HIF prompted by vadadustat stimulate endogenous erythropoietin production, increasing iron mobilization and contributing to the gradual rise of hemoglobin (Hb) levels and the correction of iron metabolism. In patients with anemia of CKD, in whom normal erythropoiesis is dysfunctional, this leads to the correction of anemia.

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 Vadadustat, just click the ADD TO CART button.

HBEL

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