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Bioavailability study

Aim:

To determine the absolute or relative bioavailability of the test item.

Species:

Species used for preclinical R&D, no NHP.

Absolute bioavailability:

In life phase: Single intravenous and extravascular administration of the test item. For rats, if useful jugular vein cannulated model is used. Collection of blood/serum/plasma samples at scheduled time-points.

Bioanalysis: Quantification of the test item in the blood/serum/plasma samples by reliable bioanalytical method.

Evaluation: Determination of the pharmacokinetic parameters by Phoenix WinNonlin software and calculation of the absolute bioavailability: as ratio of the extravascular and intravenous total systemic exposure.

Relative bioavailability:

In life phase:

Single extravascular administration of the test item

  • with different doses of the same type of formulation (dose-dependency of exposure)
  • with different formulations at the same dose level (exposure for different formulations)
  • using different administration routes (comparison of administration routes)
  • using the same dosage form in fasted and fed animals (food effect).

Bioanalysis: Quantification of the test item in the blood/serum/plasma samples by reliable bioanalytical method.

Evaluation: Determination of the pharmacokinetic parameters by Phoenix WinNonlin software and calculation of the relative bioavailability as ratio of the total systemic exposures to evaluate the dose-dependency, formulation effect, effect of administration routes or food effect.

Collecting different matrices from the same animals (e.g. plasma and brain) the organ/plasma concentration ratios and the relative tissue/plasma bioavailability can be evaluated.

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