Types of Studies

    • Maximum Tolerated Dose
    • Dose Range Finding


    General recommendations and objectives

    • The current view is that adequate information on acute toxicity can be obtained from other sources than specific single-dose toxicity
    • “Extended” single-dose toxicity studies evaluate hematology, clinical chemistry, necropsy and histopathology


  • Clinical Signs (morbidity and mortality)
  • Detailed clinical examination at least twice on the day of exposure (this includes changes in skin and fur, eyes, breathing rate, somatomotor activity and behavior
  • Necropsy
  • Organ Weight
  • Fixation


  • EMA/CHMP/SWP/81714/2010
  • CHMP/SWP/302413/08
  • OECD 402, 420, 423, 425

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