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SUB-ACUTE TOXICOLOGY

Types of Studies

    • 14 days
    • 28 days with recovery period – GLP compliant

     

    General recommendations and objectives

    • Repeated dose toxicity studies should be carried out in two mammal species (one non-rodent)
    • Duration of repeated dose toxicity studies depends on the duration of the proposed therapeutic use in humans
    • The route of administration should be the same as intended for humans
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Readouts

  • Clinical Signs (morbidity and mortality)
  • Food consumption; body weight
  • Clinical Examination – tumors, distended abdomen, kyphosis, etc
  • Ophthalmologic examination – cataracts, eye discharge, corneal opacity, etc
  • Functional Observational Battery (FOB) – tail stiffening, forelimb grip strength, body temperature, etc
  • Neuronal Observational Battery (NOB) – gait disorders, tremor, menace reflex
  • Necropsy
  • Organ Weight
  • Fixation

Guidelines

  • CPMP/SWP/1042/99 Rev. 1 Corr
  • OECD 407, 410

Services

Contacts

Office:
Avenida da Liberdade, 258, 6º
1250-149 Lisboa, Portugal

 

+351 210 976 863

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