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Bioequivalence Studies
- The Clinical phase is conducted at our affiliated clinical sites
- The Bioanalytical phase is conducted at affiliated Laboratories, accredited & validated, with extensive experience in bioanalysis & state-of-the-art instrumentation & technology
Study design & protocol development
Clinical phase
- Subject recruitment
- Blood sampling
- Sample handling
- AE reporting
Bioanalysis
- Analytical method development & determination of active compounds in biological fluids
- Bioanalytical method validation assay methods
Pharmacokinetics
- Determination of pharmacokinetic parameters
- Pharmacokinetic modeling & simulation
Biometrics
- Data management
- Statistical programming & analysis
Integrated clinical study report
- Clinical, bioanalytical, pk, biometrics reporting
Submission to regulatory authorities, follow-up of the approval procedures & expert opinion
