Vitamin K1

CAS number
84-80-0
Application
Phytonadione (vitamin K1) is a medication used to treat and manage vitamin K deficiency, which is a significant risk factor for intracranial hemorrhage and other bleeds.
Molecular weight
450.7 g/mol
Molecular formula
C31H46O2
Routes
Oral, 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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