European Society of Toxicologic Pathology (ESTP)
    European Society of Toxicologic Pathology
Testing strategies


  • ICH Topic S6: Preclinical safety evaluation of biotechnology-derived pharmaceuticals
    EMEA, July 1997
    size: 85 kB

  • Guidance on similar biological medicinal products
    EMEA, October 2005
    size: 106 kB, EMEA Web server

  • Additional literature
    • Vargas HM, Bass AS, Breidenbach A, Feldman HS, Gintant GA, Harmer AR, Heath B, Hoffmann P, Lagrutta A, Leishman D, McMahon N, Mittelstadt S, Polonchuk L, Pugsley MK, Salata JJ, Valentin JP (2008) Scientific review and recommendations on preclinical cardiovascular safety evaluation of biologics. J Pharmacol Toxicol Methods 58: 72-76
      PubMed abstract.

    • Coe Clough NE, Hauer PJ (2005) Using polyclonal and monoclonal antibodies in regulatory testing of biological products. ILAR J 46: 300-306
      PubMed abstract.

    • Hendriksen CF (2002) Refinement, reduction, and replacement of animal use for regulatory testing: current best scientific practices for the evaluation of safety and potency of biologicals. ILAR J 43 Suppl: S43-S48
      PubMed abstract.

Endocrine modulating compounds (including Endocrine disruptors)

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