OEL Fastrac Catalog

Lasmiditan is in phase 3 clinical trials for treatment of acute migraine headaches. Lasmiditan is a selective serotonin receptor 5-HT1F agonist, which is centrally acting and penetrates the blood-brain barrier. It shows high affinity for the 5-HT1F receptor, which are found on trigeminal neurons, cortex, and cerebellum, and low affinity for 5-HT1B and 5- HT1D receptors. Studies suggest that a 5-HT1F agonist may act through direct neural mechanisms in the trigeminal system without vasoconstrictive side effects seen with 5-HT1B activation by triptan drugs. Lasmiditan is designed to block the activation of the trigeminal nerve pathway that transmits the sensation of headache pain and to block neurogenic inflammation of the meninges, believed to contribute to migraine headache pain.

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 Lasmiditan, just click the ADD TO CART button.

HBEL

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