OEL Fastrac Catalog

Enobosarm, also known as ostarine, is an investigational selective androgen receptor modulator (SARM), for the treatment of conditions such as muscle wasting and osteoporosis. Enobosarm has been tested in Phase I, II and III trials with promising results in terms of improving lean body mass and measurements of physical function and power. Enobosarm has received fast-track designation by the United States (US) Food and Drug Administration (FDA). Enobosarm is a SARM with an inhibitory constant (Ki) of 3.8 nM and is tissue-selective for anabolic organs. Enobosarm is in Phase II clinical trials for breast cancer and stress incontinence. The clinical development program for cachexia and muscular atrophy was discontinued. Enobosarm is an investigational drug and therefore not approved for any use by the US FDA. Despite this, it is still sometimes found in dietary supplements, particularly those marketed for bodybuilding. Enobosarm, along with other SARMs, is banned by the World Anti-Doping Agency (WADA) and the National Collegiate Athletic Association (NCAA).

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 Enobosarm, just click the ADD TO CART button.

HBEL

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