OEL Fastrac Catalog

Moxidectin is a macrocyclic lactone that is used to control a range of internal and external parasites. In humans, moxidectin tablets are indicated for the treatment of onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older. Moxidectin is also indicated to prevent or control parasitic worms (helminths), such as heartworm and intestinal worms in dogs, cats, horses, cattle and sheep. For human uses, moxidectin is supplied as a tablet for oral administration and was approved by the United States Food and Drug Administration in 2018 by a nonprofit biopharmaceutical company Medicines Development for Global Health. For animals uses, moxidectin is available as tablets, topical solution and gel and solution for subcutaneous injection under different tradenames.

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 Moxidectin, just click the ADD TO CART button.

HBEL

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