Oxaliplatin

CAS number
61825-94-3
Application
Platinum compounds
Molecular weight
397.2859 g/mol
Molecular formula
C6H14N2.C2O4.Pt
Routes
Intravenous

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.

How to initiate a quotation request and a supplier qualification within your quality system?