OEL Fastrac Catalog

Brexanolone is mixture of allopregnanolone and sulfobutylether-beta-cyclodextrin in development for treatment of postpartum depression and refractory status epilepticus. Although exact mechanism leading to post-partum depression is not known, preclinical clinical work suggests a role for GABAA receptors. Allopregnanolone, the active ingredient in brexanolone, is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors. During pregnancy increasing concentrations of allopregnanolone lead to GABA inhibition which must be quickly reversed at parturition when allopregnanolone concentrations rapidly decline. Treatment with brexanolone is intended to make up for the rapid drop in allopregnanolone at parturition.

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 Brexanolone, just click the ADD TO CART button.

HBEL

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