Apalutamide is an androgen receptor antagonist indicated for the treatment of patients with non-metastatic, castration-resistant prostate cancer (NM-CRPC). Apalutamide is a potent androgen receptor (AR) antagonist with an IC50 of 16 nM (2). Apalutamide binds and blocks AR nuclear translocation, inhibits DNA binding, and impedes AR-mediated transcription (2, 3). Persistent AR signaling is a common feature of CRPC, attributed to AR gene amplification, AR gene mutation, increased AR expression, or increased androgen biosynthesis in prostate tumors (2). Apalutamide has off-target activity against the GABA ion channel, inhibiting GABA ligand binding to the GABAA chloride channel with an IC50 of 0.88 μM, in vitro.
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 Apalutamide, 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.