In order to reach reasonable regulatory milestones and to avoid expensive late-stage failures, efforts must be directed to collect maximum data at an early stage of the discovery process.
Pre-clinical group offers extensive capabilities to conduct
pharmacokinetic evaluations and analyses in animals. These inlife studies provide information for the selection of dose levels, dosing frequency, formulation, routes of administration, exposure, and interspecies comparisons.
Studies can be performed on mice, rats, rabbits, swine, dogs and monkeys.
Analytical determination are performed in a fully GLP certified laboratories, using various chemical analytical Methods- HPLC, LC/MS LC/MS/MS, including Methods development and Methods Validations.
Sample analysis can be preformed in various media (Plasma, Urine and Tissues).
Pharmacokinetic analysis is performed by pharmacokinetic experts using WinonLin ® software and expert bio-statistician
