Diclofenac diethylamine

CAS number
78213-16-8
Application
Diclofenac diethylamine is an anti-inflammatory drug that is an inhibitor of leukocyte migration and the enzyme cyclooxygenase (COX-1 and COX-2)
Molecular weight
369.29 g/mol
Molecular formula
C14H11Cl2NO2.C4H11N
Routes
Topical, Oral

SOCOSUR PDE monographs are a quick and efficient way to obtain:

  • Risks identification
  • Identification of potential critical effects
  • Rationale for NOAEL values selection
  • Complete description of adjustment factors F1 to F5 as well as PK correction
  • Complete review of all relevant pharmaceutical and medical databases, public or private, European or not in accordance with EMA guideline EMA/CHMP/CVMP/SWP/169430/2012, signed by an European toxicological expert with full CV

Benefits of such PDE monograph

A 16 to 25 pages report optimized in case of Regulatory Body inspection with all calculation details and all bibliographic references linked to these calculations.

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