OEL Fastrac Catalog

Isotretinoin is indicated for the treatment of severe recalcitrant nodulocystic acne. Isotretinoin also known as 13-cis retinoic acid, is classified as a retinoid, which is a synthetic analogue of vitamin A. Its exact mechanism of action is not known. When administered in pharmacologic dosages, isotretinoin inhibits sebaceous gland function and keratinization. In nodular acne, clinical improvement is associated with a reduction in sebum secretion which is related to the dose and duration of isotretinoin treatment. Retinoids affect the keratinization process, and therefore without specificity exhibit effectiveness in all types of hyperkeratotic conditions.

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 Isotretinoin, just click the ADD TO CART button.

HBEL

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