Clinical Pharmacokinetics and Pharmacodynamics

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. We offer high-quality procedures and results complying with international regulatory standards (FDA, EMEA, ICH), in the largest Phase I facilities in EU (two clinical units in Antwerp and Paris totaling 172 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.

Exploratory DevelopmentExploratory Development to Proof of Concept Integrated services reduce time to market (PDF 876KB) ...

14C ADME Clinical TrialsWhy, When, and How to Conduct 14C Human StudiesFactors in conducting a radiolabeled ADME study (PDF 185KB) ...

Interactive Pocket MapLife Science Services & Sites Pocket MapA quick reference to our global sites and services

Now Viewing

All 3 resources

• 

  Exploratory Development

  published 02/28/12

  PDF

• 

  14C ADME Clinical Trials

  published 02/29/12

  PDF

• 

  Interactive Pocket Map

  published 01/31/12

  Video