OEL Fastrac Catalog

Rintatolimod is a member of a new class of specifically configured ribonucleic acid (RNA) compounds targeted as potential treatment of diseases with immunologic defects and/or viral causation, including chronic fatigue syndrome (CFS, also called myalgic encephalomyelitis (ME)/CFS), human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), certain types of cancer, both avian flu and swine flu (H1N1), and the Ebola virus. In vitro, rintatolimod has been shown to inhibit replication of other human coronaviruses (such as severe acute respiratory syndrome-related virus (SARS)44 and Middle East respiratory syndrome-related coronavirus (MERS)) that are associated with high morbidity. Rintatolimod is to be tested as a prophylaxis/early-onset agent against coronavirus disease 2019 (COVID-19) in a clinical trial conducted by Japan’s National Institute of Infectious Diseases (NIID) and the University of Tokyo.

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 Rintatolimod, just click the ADD TO CART button.

HBEL

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