OEL Fastrac Catalog

Etrasimod arginine is in development for the treatment of immune-mediated diseases, including ulcerative colitis. A clinical trial (NCT03945188 and NCT03996369) is ongoing to investigate the effect of etrasimod for the treatment of moderately to severely active ulcerative colitis. Etrasimod arginine, also known as APD334, is an investigational oral medication that acts as a full agonist on sphingosine-1-phosphate (S1P)1, S1P4, and S1P5 receptors. It is currently being developed to address conditions associated with immune responses and inflammation. Etrasimod arginine has also shown inhibitory effects on pro-inflammatory cytokines like tumor necrosis factor-alpha (TNF-α), interleukin (IL)-1β, IL-6, and IL-17A, while enhancing the activity of the anti-inflammatory cytokine IL-10.

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 Etrasimod Arginine, just click the ADD TO CART button.

HBEL

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