OEL Fastrac Catalog

Savolitinib, also referred to as AZD6094 and HMPL-504, has been used in trials studying the treatment and health services research of tumors, food effects, gastric cancer, and colorectal cancer, among others. Savolitinib has been demonstrated to inhibit the growth of tumors in a series of preclinical disease models, selectively for those tumors with aberrant c-Met signaling. It has shown favorable pharmacokinetic properties in late stage cancer patients, and has shown encouraging anti-tumor activity in several tumor-types, particularly for metastatic papillary renal cell cancer (PRCC). Savolitinib is an orally bioavailable inhibitor of the c-Met receptor tyrosine kinase (IC 50 3 – 5 nM) with potential antineoplastic activity. It selectively binds to and inhibits the activation of c-Met in an ATP-competitive manner, which disrupts c-Met signal transduction pathways. This may result in cell growth inhibition in tumors that overexpress the c-Met protein. The ligand for c-Met is hepatocyte growth factor (HGF), which activates a wide range of cellular signaling pathways, including those involved in proliferation, invasion, metastasis and tumor angiogenesis. C-Met has been found to be highly activated in a number of human cancers.

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 Savolitinib, just click the ADD TO CART button.

HBEL

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