OEL Fastrac Catalog

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.

Why do you need this OEL Fastrac monograph?

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:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Ipatasertib, just click the ADD TO CART button.

HBEL

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