Pharmacokinetic studies in marmosets and cynomolgus macaques

As a prerequisite for human clinical trials, preclinical studies have to confirm tolerability of test compounds in relevant species. According to the S6 guideline for preclinical safety evaluation of biotechnology-derived pharmaceuticals, “a relevant species is one in which the test material is pharmacologically active due to the expression of the receptor or an epitope […]”. In case of biopharmaceuticals addressing human-specific target, non-human primates are often the only relevant species. A high sequence homology compared to humans allows an exceptional transferability of results obtained in preclinical studies. Here we provide the possibility to analyze test compound distribution in non-human primates in vivo, as well as ex vivo.

Species

Marmoset monkeys (Callithrix jacchus), cynomolgus macaque (Macaca fascicularis)

Field of application

  • Preclinical safety testing

Endpoints/Outcome parameter

  • Compound distribution

Readout parameter

  • Scoring for animal behavior
  • Blood analysis of plasma, serum, whole blood
  • Bronchoalveolar lavage: distribution of compound after intratracheal administration
  • Macropathology, Histopathology: conventional staining and tissue pathohistology/conventional microscopy (e.g. tissue cell infiltration), immunohistochemistry
  • Tissue analysis regarding compound distribution

Quality management and validation

  • Internal quality management
  • Historical data available
  • Accurate observance of EU directive 2010/63/EU on the protection of animals used for scientific purposes and of the German animal protection law

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