OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Tivozanib hydrochloride (CAS RN 682745-41-1) and Tivozanib hydrochloride anhydrous (CAS RN 682745-43-3). Tivozanib is an orally bioavailable inhibitor of vascular endothelial growth factor receptors (VEGFRs) 1, 2, and 3 with potential antiangiogenic and antineoplastic activities. Tivozanib is approved in the United States of America (USA) for the treatment of relapsed or refractory renal cell carcinoma in adult patients who have undergone two or more systemic therapies. In the United Kingdom (UK) and other countries, it is indicated as first-line therapy for adults with advanced renal cell carcinoma (RCC) and VEGFR and mammalian target of rapamycin (mTOR) pathway inhibitor-naïve patients after disease progression following one previous treatment with cytokine therapy for advanced disease.

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 Tivozanib, just click the ADD TO CART button.

HBEL

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