OEL Fastrac Catalog

Cemiplimab is a fully human monoclonal antibody that works against programmed death receptor-1 (PD-1) and programmed death ligand-1 (PD-L1). Cemiplimab is indicated for the adjuvant treatment of adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation, as well as for the treatment of adult patients with metastatic CSCC (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. Cemiplimab is also indicated for the for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) or metastatic basal cell carcinoma (mBCC) who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate. It is indicated to treat non-small cell lung cancer (NSCLC) as first-line treatment of adult patients with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or reactive oxygen species (ROS) protooncogene 1 aberrations and who are not candidates for surgical resection or definitive chemoradiation. It is also indicated to treat metastatic NSCLC combination with platinum-based chemotherapy as first-line treatment in adults, and locally advanced or metastatic NSCLC as monotherapy for the first-line treatment of adults whose tumors have high PD-L1 expression (Tumor Proportion Score (TPS) ≥ 50 with no EGFR, ALK, or ROS1 aberrations. Cemiplimab is also indicated to treat recurrent or metastatic cervical cancer in adults with disease progression on or after platinum-based chemotherapy.

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 and the Permitted Daily Exposure (PDE) 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 Cemiplimab, just click the ADD TO CART button.

HBEL

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