Aflibercept

CAS number
862111-32-8
Application
Aflibercept is a medication used to treat and manage neovascular age-related macular degeneration, diabetic macular edema, myopic choroidal neovascularization, macular edema associated with retinal vein occlusion, and diabetic retinopathy.
Routes
Injectable

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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