To determine the absolute or relative bioavailability of the test item.
Species used for preclinical R&D, no NHP.
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.
In life phase:
Single extravascular administration of the test item
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.