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Pharmacokinetic support of pharmacological/ toxicity studies

Aim:

Investigate the relationship between the pharmacodynamic/toxicity response(s) and the corresponding systemic/target site exposure of the test item.

Design:

In life phase:

  • Administration of the test item to the relevant animal species
  • Monitoring of the pharmacological/toxicological responses
  • Sampling of the required biological matric(es) to measure the test item concentrations
  • Sampling of the required biological matric(es) to measure the relevant biochemical/histochemical/histopathological responses

Biological evaluation and bioanalysis:

Monitoring the pharmacodynamic effect: application of the relevant methods to measure the specific responses and concentrations of the relevant biomarkers e.g:

  • Hematology or clinical chemistry parameters
  • Immunological response factors
  • Inflammatory response factors
  • Histopathological evaluation
  • etc.

Monitoring of the exposure: quantification of the test item in plasma and/or target matrix (by LC/MS/MS, ELISA etc.)

Outcome:

Correlation between the test item concentrations/total exposure and the biological response(s) for a defined time period.

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Auri Knowledge
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