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Single and multiple dose pharmacokinetic study

Aim:

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.

Species:

All animal species used for preclinical R&D, no NHP.

Design:

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.

Outcome:

Pharmacokinetic evaluation: by validated Phoenix WinNonlin software.

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