Please note, this OEL/ADE monograph also applies to afatinib dimaleate (CAS RN 850140-73-7). Afatinib dimaleate is indicated for the treatment of metastatic non-small cell lung cancer in patients with epidermal growth factor receptor (EGFR) mutations and patients with squamous non-small cell lung cancer who have progressed after platinum-based therapy. Afatinib is a kinase inhibitor that covalently binds to the kinase domains of EGFR (ErbB1), HER2 (ErbB2), and HER4 (ErbB4) and irreversibly inhibits tyrosine kinase autophosphorylation, resulting in down regulation of ErbB signaling.
Why do you need a Afatinib monograph?
Superior Toxicology and Wellness’s monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs)
- 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 Superior Toxicology and Wellness monographs:
- Full drug documentation. The report consists of 10-12 pages in length, with calculations and cited references.
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