OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Exatecan mesylate anhydrous (CAS RN 169869-90-3), and Exatecan mesylate (CAS RN 197720-53-9). Exatecan, also known as DX 8951, is semisynthetic, water-soluble camptothecin derivative and topoisomerase I (TOP-1) inhibitor with antineoplastic activity. DE-310, a unique polymer prodrug of exatecan, which was developed to achieve protracted systemic exposure to the active drug after a single dose, is also undergoing early clinical development. Exatecan has been used intravenously (IV) in clinical trials studying the treatment of sarcoma, leukemia, lymphoma, lung cancer, pancreatic cancer, and liver cancer among others. However, the development of exatecan as a single agent ceased due to dose-limiting side effects and the absence of therapeutic benefits in combination with gemcitabine compared with gemcitabine alone in clinical testing. Exatecan is being reevaluated in the context of tumor-targeted drug delivery approaches as TOP-1-based antibody-drug conjugates (ADC), being investigated as cytotoxic payload itself, or as its derivative deruxtecan.

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 Exatecan, just click the ADD TO CART button.

HBEL

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