OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Crizotinib hydrochloride (CAS RN 1415560-69-8) and Crizotinib acetate (CAS RN 877399-53-6). Crizotinib is indicated for non-small cell lung cancer. Crizotinib is a kinase inhibitor, including anaplastic lymphoma kinase (ALK). In ALK-positive patients with non-small cell lung cancer, this inhibition prevents the expression of oncogenic fusion proteins from activating gene expression, which subsequently impairs cell proliferation and survival of these proteins in tumors.

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 Crizotinib, just click the ADD TO CART button.

HBEL

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