Panobinostat lactate is indicated in the treatment of patients with relapsed and/or refractory multiple myeloma in combination with dexamethasone and bortezomib in patients who have received at least two (2) previous treatment regimens including bortezomib and an immunomodulatory agent. Panobinostat lactate is a hydroxamic acid analog histone deacetylase (HDAC) inhibitor that prevents the enzymatic activity of HDACs at nanomolar concentrations. Histone deacetylase enzymes target lysine groups on histones and various non-histone proteins such as p53 atubulin, heat shock protein 90 (HSP90) and HIF-la.
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.