OEL Fastrac Catalog

Modafinil, a DEA schedule IV controlled substance, is indicated for the treatment of excessive sleepiness from narcolepsy, obstructive sleep apnea or shift work sleep disorder. In July 2010, the EMEA's Committee for Medicinal Products for Human Use (CHMP) reported on its safety review of modafinil. The committee concluded that the benefits of modafinil only outweighed the risks in narcolepsy. For all other indications the risk of developing skin or hypersensitivity reactions and neuropsychiatric disorders outweighed efficacy. Therefore, the CHMP concluded that all indications except narcolepsy should be withdrawn from the marketing authorizations for modafinil.

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 Modafinil, just click the ADD TO CART button.

HBEL

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