OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to degarelix acetate (CAS RN 934016-19-0) and degarelix acetate hydrate (CAS RN 934246-14-7). Degarelix is a long-acting synthetic peptide with gonadotrophin-releasing hormone (GnRH) antagonistic properties. It is used for the management of advanced prostate cancer. Degarelix is a synthetic derivative of GnRH decapeptide, the ligand of the GnRH receptor. Gonadotropin and androgen production result from the binding of endogenous GnRH to the GnRH receptor. Degarelix antagonizes the GnRH receptor, which in turn blocks the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) from the pituitary. Luteinizing hormone (LH) and FSH decrease in a concentration-dependent manner. The reduction in LH leads to a decrease in testosterone release from the testes, which slows the growth and reduces the size of prostate 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 Degarelix, just click the ADD TO CART button.

HBEL

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