OEL Fastrac Catalog

Aclerastide is being investigated for the treatment of diabetic wound healing, and more specifically for diabetic foot ulcers (DFU). It failed Phase III clinical trials in November 2015 for treatment of DFU, where it was applied daily for several weeks. Aclerastide, also known as DSC-127, and NorLeu3-A(1-7), is a potent peptide analog of angiotensin II, a growth factor that plays an important role in dermal repair and wound healing by promoting angiogenesis, producing reactive oxygen species, and inducing migration of fibroblasts and keratinocytes. In animal models, aclerastide showed more rapid deposition of collagen, acceleration of epithelial growth, altered leukocyte infiltration, and increased blood vessel formation.

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 Aclerastide, just click the ADD TO CART button.

HBEL

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