Please note, this OEL/ADE monograph also applies to Ipatasertib monohydrochloride (CAS RN 1489263-16-2) and Ipatasertib dihydrochloride (CAS RN 1396257-94-5). Ipatasertib is a serine/threonine-protein kinases (Ak strain transforming (AKT)) inhibitor under investigation for the treatment of cancer, neoplasms, solid cancers, breast cancer, and gastric cancer among others. Ipatasertib is an adenosine triphosphate (ATP)-competitive small molecule inhibitor of all three isoforms of AKT. Ak strain transforming (AKT) is a key component of the phosphatidylinositol 3-kinase (PI3K)/AKT pathway. This pathway is dysregulated in many malignancies, often through the acquisition of activating mutations in AKT and phosphatidylinositol 3-kinase (PI3K), loss of the tumor suppressor phosphatase and tensin homolog (PTEN), or amplification of AKT and PI3K. Some cancer treatments have led to the aberrant activation of the PI3K/AKT pathway, which resulted in the survival and proliferation of tumor cells. In various preclinical models, PI3K/AKT/mammalian target of rapamycin (mTOR) signaling was shown to become activated following chemotherapy or antihormonal therapy. Ipatasertib is designed to target and bind to the ATP–binding pocket of the 3 activated isoforms of AKT, potentially inhibiting downstream signaling.
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:
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