Early toxicology studies

Cynbiose provides early toxicology services to support the clinical development of your therapeutic in order to derisk your development or refine the design of your regulatory studies.

  • Non-GLP safety studies
    • Dose escalation studies
    • Dose Range Finding (DRF) studies
    • Evaluation of toxicological doses: NOEL, NOAEL, Maximum Tolerated Dose (MTD)
    • Evaluation of chronic toxicity

Our study designs include the monitoring of clinical signs, clinical pathology and histopathology.

  • GLP studies (for more information please contact us)

We are experienced in handling small molecules, peptides, biologics, immunotherapies, antibodies, proteins, vaccines and viral vectors that are being developed in all types of indications for human health.

 

Our preclinical services for non-GLP toxicology include:

  • Plasma and CSF drug profiles following most routes of administration including intrathecal and aerosolization (renvoi vers listing avec ROA)
  • Daily in-depth clinical monitoring for early detection of adverse effects, based on the specificity of the suspected drugs’ MOA
  • Dynamic change physiological parameters and other biomarkers of interest
  • Implanted or classical body temperature monitoring
  • Custom-designed evaluation grids
  • Biomarkers analysis in different fluids (plasma, serum, urine, bronchoalveolar lavage, ….) and tissues depending on the studies’ objectives.
  • Immunomonitoring
  • Immunogenicity
  • Immunotoxicology
  • Histopathology
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