OEL Fastrac Catalog

Adagrasib is an experimental Kirsten rat sarcoma viral oncogene homolog (KRAS) inhibitor being investigated for the treatment of KRASG12C mutant lung and colon adenocarcinomas. Adagrasib is an orally available, small molecule inhibitor that targets the oncogenic KRAS substitution mutation, G12C, with potential antineoplastic activity (2, 4). Normally, guanosine triphosphate (GTP) binds to KRAS, activating the protein and promoting effectors to the mitogen-activated protein (MAP) kinase pathway. Guanosine triphosphate (GTP) is hydrolyzed to guanosine diphosphate (GDP), and KRAS is inactivated. Kirsten rat sarcoma viral oncogene homolog (KRAS)G12C mutations impair hydrolysis of GTP, leaving it in the active form.

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 Adagrasib, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.