OEL Fastrac Catalog

Ibrutinib is an orally bioavailable, small-molecule inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity. Ibrutinib acquired an accelerated approval for the treatment of mantle cell lymphoma (for patients who have received at least one prior therapy). Mantle cell lymphoma (MCL) is a Bcell non-Hodgkin lymphoma that develops in the outer edge of a lymph node. Mantle cell lymphoma (MCL) is usually diagnosed at late stages, and it is easily spread into bone marrow, spleen, liver and the gastrointestinal (GI) tract Ibrutinib is indicated for the treatment of chronic lymphocytic leukemia (CLL) (for patients who have received at least one prior therapy). Chronic lymphocytic leukemia (CLL) is a type of cancer caused by an overproduction of lymphocytes by the bone marrow. Some of the symptoms include swollen lymph nodes and tiredness. Other indications are described in the monograph.

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 Ibrutinib, just click the ADD TO CART button.

HBEL

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