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Bioanalytical support of clinical trials

Aim:

To provide bioanalytical support to Phase I, Phase II, Phase III, bioavailability, bioequivalence, interaction, food-effect or PK/PD clinical studies.

Procedure:

1. Development and validation of the relevant bioanalytical method(s).

2. Analysis of the samples supplied by the clinical site in compliance with GLP and GCP requirements.

Phase I, Phase II, Phase III, bioavailability, bioequivalence and food effect studies:

  • Quantification of the test item (and its metabolites having reference standard) in plasma

Interaction study:

  • Quantification of the test items simultaneously present in plasma

PK/PD clinical studies:

  • Quantification of the test item (and its metabolites) in plasma
  • Measurement of the specific responses, concentrations of the relevant biomarkers

3. Pharmacokinetic evaluation by Phoenix WinNonlin or SAS software.

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Auri Knowledge
Auri Knowledge