OEL Fastrac Catalog

Erdafitinib is an orally administered drug in phase 2 and 3 clinical trials for the treatment of advanced refractory solid tumors, particularly in urothelial cancer. Erdafitinib is a potent, selective fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor. FGFRs are transmembrane proteins that regulate key processes including cell migration, proliferation, differentiation, and survival, particularly in embryonic development and during inflammation and wound healing. FGFRs are present in many types of cells including skin, mucosa, and bone, as well as tumor cells, and have been shown to play a critical role in tumor cell growth, survival, migration, and angiogenesis. Deregulation of FGFR pathways and FGFR-activating mutations have been associated with progression of human malignancies including breast, lung, prostate, endometrial, gastric, and urothelial carcinomas. Erdafitinib has demonstrated target inhibition and pathway modulation in FGFR pathway activated cellular models of various cancers including lung, breast, gastric, bladder, and liver.

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 Erdafitinib, just click the ADD TO CART button.

HBEL

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