
All studies are performed according to GLP
In vitro toxicology studies
- mutagenesis (AMES assay)
- genotoxicity
- hematotoxicity on human hematopoetic progenitors (CD34+)
In vivo toxicology studies
- toxicity evaluation in rodents:
different route of administration
(PO,IV,IP,SC,IM)
- acute toxicity in rodent (lethal doses,
macroscopic toxicity) - treatment of
rodent for 1 to 5 days
- chronic toxicity in rodent (macroscopic tox., hepatotox., hematotox.) -
treatment of rodent for 3 weeks to 24 months
Ex vivo toxicology and metabolism
- activity of CYP450
- hematology (numeration, coagulation, glycemia, insulinemia, enz. activity,...)
All that assays are performed according to the international regulatory
- AMES regulatory assay - OECD 471 - 21st July 1997
- Sub chronic and chronic toxicity - OECD 408 - 21sd September 1998
- Acute toxicity - OECD 425 - 17th December 2001
- Tumorogenicity - European Pharmacopoeia - EP5.2.3
- Detection of viral determinant - European Pharmacopoeia
Production of metabolites (S9 fraction)
Induction or Inhibition of CYP450
Induction or Inhibition of GST
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