OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to baclofen hydrochloride (CAS RN 28311-31-1), Arbaclofen (CAS RN 69308-37-8). and Arbaclofen hydrochloride (CAS RN 63701-55-3). Baclofen is a muscle relaxant and antispastic with oral therapy indicated for spasticity. The precise mechanism of action of baclofen has not been fully determined. Baclofen exerts its effects as an agonist at presynaptic GABA-B (bicuculline-insensitive) receptors. It acts mainly at the spinal cord level to inhibit the transmission of both monosynaptic and polysynaptic reflexes, possibly by hyperpolarization of primary afferent fiber terminals, resulting in antagonism of the release of putative excitatory transmitters (i.e., glutamic and aspartic acids).

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 Baclofen, just click the ADD TO CART button.

HBEL

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