Please note, this OEL/ADE monograph also applies to gefitinib hydrochloride (CAS RN 184475-55-6). Gefitinib is indicated to treat non-small cell lung cancer, epidermal growth factor receptors (EGFR)-positive metastatic first-line treatment. Gefitinib, a tyrosine-kinase inhibitor of activating mutations of EGFR, prevents the autophosphorylation, thereby inhibiting downstream signally and blocking EGFRdependent proliferation. Its affinity for EGFR exon 19 deletion or exon 21 point mutation L858R mutations is higher than affinity for wild-type EGFR.
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), as well as PIC/S and ANVISA requirements, and to obtain the following information:
To order an OEL/ADE monograph for Gefitinib, just click the ADD TO CART button.
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Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.
Affygility Solutions’ 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.