OEL Fastrac Catalog

Anastrozole is a nonsteroidal inhibitor of estrogen synthesis that resembles paclitaxel in chemical structure. As a third-generation aromatase inhibitor, anastrozole selectively binds to and reversibly inhibits aromatase, a cytochrome P-450 enzyme complex found in many tissues including those of the premenopausal ovary, liver, and breast. Aromatase catalyzes the aromatization of androstenedione and testosterone into estrone and estradiol, the final step in estrogen biosynthesis. In estrogen-dependent breast cancers, anastrozole may inhibit tumor growth. Anastrozole is indicated as adjunct therapy in the treatment of hormone receptor-positive early breast cancer in postmenopausal women, and as a first-line treatment for hormone receptor-positive (or hormone receptor-unknown) locally advanced or metastatic breast cancer in postmenopausal women. Anastrozole may also be used in the treatment of advanced breast cancer in postmenopausal women who experience disease progression despite treatment with tamoxifen.

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the Permitted Daily Exposure (PDE) 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 monograph for Anastrozole, just click the ADD TO CART button.

HBEL

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