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As a world leader in clinical trials, SGS provides you with extensive clinical pharmacokinetics services and analysis (PK) and pharmacodynamic (PD) support in pre-clinical and Phase I to III clinical studies.

Stetoscope

We offer high-quality procedures and results complying with international regulatory standards (FDA, EMEA, ICH), in Phase I facilities in the EU (in Antwerp, totaling 92 beds). 

Clinical Expertise

  • Pre-clinical PK and toxicokinetics (GLP compliant)
  • Bioequivalence and comparative bioavailability
  • ADME pharmacokinetic services (C14 studies)
  • Modified release formulations
  • Transdermal drug delivery
  • Inhaled drugs
  • Immunological response
  • PD profiling of pharmacological effects, including a large range of biomarkers

Pharmacokinetic and Pharmacodynamic Analysis

Our pharmacokineticists each have, on average, over 10 years’ experience, and support our clients with:

  • Expert PK input to preclinical and clinical development plans
  • Evaluation of safety data and animal tissue distribution data
  • Study design: sample size calculation, optimized sampling schedule
  • Non-compartmental and compartmental analysis
  • PK/PD Modeling and simulation (including population approach)
  • Pooled analysis
  • Statistical analysis and reporting of PK and PD outcomes
  • Preparation of scientific publications and investigator brochures
  • Experience with all kind of study designs and data analysis, like, first-in-human, DDI, BA/BE, PK, POC, ADME (C14) and PK in special populations

Software tools

  • WinNonlin®
  • NonNem®
  • Sigmaplot facilities, for macro creation and statistical reporting.

Contact SGS today to learn how we can help with your clinical pharmacokinetics and pharmacodynamics testing.