To investigate the pharmacokinetic properties of the test item after single administration and at steady state.
Single dose: to determine the pharmacokinetic parameters such as lagtime, Tmax, Cmax, AUC, t½, volume of distribution, clearance, mean residence time
Multiple dose: to characterize the steady-state pharmacokinetics with Cmin, Cmax, fluctuation, accumulation ratio, linearity ratio etc.
All animal species used for preclinical R&D, no NHP.
In life phase: Administration of test item and collection of the required biological matrix.
Administation routes: intravenous including infusion, intraperitoneal, intramuscular, subcutaneous, intradermal, topical, oral and additional special routes as intranasal, sublingual, buccal, intraarticular etc.
Bioanalysis: Concentrations of the test item (and its metabolites, if applicable) are quantified in blood/serum/plasma/target organ by reliable bioanalytical method. The relevant bioanalytical methods (LC-MS/MS, ELISA etc.) are developed /implemented.
Pharmacokinetic evaluation: by validated Phoenix WinNonlin software.