Life Sciences 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.
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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).
- 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
- Sigmaplot facilities, for macro creation and statistical reporting.
Contact SGS today to learn how we can help with your clinical pharmacokinetics and pharmacodynamics testing.