Cobicistat is a cytochrome P450 3A (CYP3A) inhibitor indicated to increase systemic exposure of atazanavir or darunavir, as a once daily dosing regimen, in combination with other antiretroviral (ARV) agents in the treatment of HIV-1 infection. Boosting systemic exposure of ARVs while minimizing dosage allows for better treatment outcomes and a decreased side effect profile. Cobicistat is a mechanism-based inhibitor that acts as a pharmacokinetic enhancer by inhibiting CYP3A isoforms. Inhibition of CYP3A-mediated metabolism by cobicistat increases the systemic exposure of CYP3A substrates atazanavir and darunavir; therefore, enabling increased anti-viral activity at a lower dosage. Cobicistat does not have any anti-HIV activity on its own.
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:
To order an OEL monograph for this compound, just click the ADD TO CART button.
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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.