Life Sciences Clinical Pharmacokinetics and Pharmacodynamics
As a world leader in early phase clinical trials, SGS provides you with extensive clinical pharmacokinetics services (PK) and analysis, and pharmacodynamic (PD) support for accurate decision making.
Our procedures and high-quality trial execution, from data capture to analyses, will help you to comply with international regulatory standards, such as FDA, EMEA and ICH. We offer clinical PK and PD services from our Phase I Clinical Pharmacology Unit (Antwerp, Belgium), and Phase I patients units (Mechelen, BE and Budapest, Hungary).
We offer you extensive expertise in:
- 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 have significant experience to support you with:
- Expert PK input to preclinical and clinical development plans
- Evaluation of in vitro, as well animal toxicology, safety and PK/PD data
- Study design, including sample size calculation and optimized sampling schedule
- Non-compartmental and compartmental analysis
- PK/PD modeling and simulation (including population approach, disease-based modeling and PBPK)
- Pooled analysis
- Statistical analysis and reporting of PK and PD outcomes
- Preparation of scientific publications and investigator brochures
- All kinds of study designs and data analysis, such as, First-In-Human (FIH), DDI, BA/BE, PK, POC, ADME (C14) and PK in special populations
All design analysis and reporting is based on ICH guidelines, and using (amongst others) WinNonlin Poenix®, NONMEM®, Simulo PK/PD modeling simulator and Bayer PNBPK software.
Correlations between administered dose and safety/activity signals are key for assessment. Our clinical team has experience with pharmacodynamic assessments in different therapeutic areas. Our modeling and simulation team collaborates with sponsors in order to develop innovative pharmacodynamic models.
Our pharmacodynamic models include:
- Anesthesia: measurement of muscle tonus reversal
- Cardiovascular: platelet aggregation, Thromboelastogram (ROTEM), tilt table, 3- and 12-lead Holter ECG and telemetry
- CNS: cerebral spinal fluid sampling, Punctum catheter, Quantitative EEG monitoring with spectral analysis, cognitive and psychometric test batteries, VAS scales, body sway, PET, short and long-term memory testing and nasal biopsies for PD markers
- Dermatology: Photosensitisation, skin bioavailability (biopsies-blisters), small plaque assay (POC) and anesthetic effect (Pin-Prick Test)
- Gastrointestinal: dual electrode gastric pH and Gastroscopy
- Hematology: bone marrow examination radiology and ROI intensity readings
- Immunology: serum conversion, wheal and flare, antihistaminic effect markers, In vivo LPS challenge for sepsis and related biomarkers
- Metabolism: oral glucose tolerance test, blood and serum markers requiring special sample and preparation
- Nephrology: glomerular filtration, renal blood flow and dialyser clearance
- Ophthalmology: intraocular blood pressure and flow, saccadic eye movements, standard tests (visual field and acuity, and color)
- Respiratory: spirometry including reversibility testing, methacholine challenge, exercise challenge, plethysmography, bodybox and sputum induction/collection
- Urology: erectile dysfunction (Rigiscan) and Bladscan
- Others: stress oxidative tests
Contact us today to learn how we can help with your clinical pharmacokinetics and pharmacodynamics testing.