Bioequivalence Studies & Pharmacokinetic Studies

  • The Clinical phase is conducted at our clinical site with capability up to 60 beds
  • The Bioanalytical phase is conducted at our accredited laboratory (GMP and GLP certified) with extensive experience in bioanalysis & state-of-the-art instrumentation & technology

Study set up

  • Study design according to EMA, FDA & ICH guidelines, literature and assessment reports
  • Protocol, CRF & ICF development
  • Dossier compilation and submission to Authorities for study approval

Clinical phase

  • Subject recruitment
  • Blood sampling
  • Sample handling
  • Monitoring

Bioanalysis

  • Analytical method development & determination of active compounds in biological fluids
  • Bioanalytical method validation

Pharmacokinetics

  • Determination of pharmacokinetic parameters
  • Pharmacokinetic modeling & simulation

Biometrics

  • Data management
  • Statistical programming & analysis

Integrated clinical study report

  • Clinical, bioanalytical, pharmacokinetics, biometrics reporting (ICH Guidelines)

Submission to regulatory authorities, follow-up of the approval procedures & expert opinion

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