OEL Fastrac Catalog

Mirdametinib is a kinase inhibitor used to treat neurofibromatosis type 1 (NF1) in children and adults. Mirdametinib is a highly selective, noncompetitive inhibitor of mitogen-activated protein kinase (MAPK)1/2. These proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway. In vitro, mirdametinib inhibited kinase activity of MAPK1 and MAPK2 and downstream phosphorylation of ERK. Mirdametinib blocks MAPK activity and the rat sarcoma (RAS)-rapidly accelerated fibrosarcoma (RAF) MAPK pathway. Therefore, MAPK inhibition blocks proliferation and survival of tumor cells in which the RAF/MAPK/ERK pathway is activated, such as NF1.

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 Mirdametinib, just click the ADD TO CART button.

HBEL

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