Please note, this OEL/ADE monograph also applies to ozanimod (CAS RN 1306760-87-1). Ozanimod is a sphingosine-1 phosphate receptor-1 and sphingolipid-5 phosphate receptor agonist currently in development for the treatment of ulcerative colitis and relapsing multiple sclerosis. Ozanimod is an oral selective sphingosine-1-phsophsine 1 and 5 receptor agonist. S1P1 receptor agonists induce internalization and degradation of S1P1 receptor, rendering B and T lymphocytes incapable of migrating to secondary lymphoid organs, which leads to a reduction of circulating lymphocytes in the blood and anti-inflammatory activity.
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.
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), and to obtain the following information:
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Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.