Leuprolide

CAS number
74381-53-6
Application
Leuprolide is a synthetic protein that acts as a natural hormone. It decreases testosterone or estrogen to treat prostate cancer or endometriosis.
Molecular weight
1269.4526 g/mol
Molecular formula
C59H84N16O12.C2H4O2
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?