OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Tazemetostat hydrobromide (CAS RN 1467052-75-0) and Tazemetostat trihydrochloride (CAS RN 1403255-00-4). Tazemetostat is an orally available, small-molecule selective and S-adenosyl methionine (SAM) competitive inhibitor of histone methyltransferase enhancer of zeste 2 polycomb repressive complex 2 subunit (EZH2), with potential antineoplastic activity. It is used to treat adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. It is also indicated for adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by a Food and Drug Administration (FDA)-approved test and who have received at least 2 prior systemic therapies. It is also indicated for adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.

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 Tazemetostat, just click the ADD TO CART button.

HBEL

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