To provide bioanalytical support to Phase I, Phase II, Phase III, bioavailability, bioequivalence, interaction, food-effect or PK/PD clinical studies.
1. Development and validation of the relevant bioanalytical method(s).
2. Analysis of the samples supplied by the clinical site in compliance with GLP and GCP requirements.
Phase I, Phase II, Phase III, bioavailability, bioequivalence and food effect studies:
PK/PD clinical studies:
3. Pharmacokinetic evaluation by Phoenix WinNonlin or SAS software.