OEL Fastrac Catalog

Firibastat (also known as RB150, and QGC-001) is used in the treatment of hypertension. Firibastat is an aminobutane-1-sulfonic acid derivative patented as an antihypertensive agent. Firibastat acts as aminopeptidase A (APA) inhibitor and suppresses the conversion of angiotensin II to angiotensin III in brain tissues. RB150 was renamed firibastat by the World Health Organization (WHO). Phase Ia/Ib clinical trials showed that firibastat is clinically and biologically well tolerated in healthy volunteers. Clinical efficacy of firibastat in hypertensive patients was demonstrated in 2 phase II studies. Firibastat represents the first drug of a novel class of antihypertensive drugs targeting the brain renin-angiotensin system.

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 Firibastat (QGC-001), just click the ADD TO CART button.

HBEL

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