Pharmacokinetic And Pharmacodynamic Services
Source: SGS Life Sciences Services
SGS provides an extensive pharmacokinetic (PK) and pharmacodynamic (PD) support in pre-clinical and Phase I-III clinical studies in accordance with international regulatory standards (FDA, EMEA, ICH).
SGS provides an extensive pharmacokinetic (PK) and pharmacodynamic (PD) support in pre-clinical and Phase I-III clinical studies in accordance with international regulatory standards (FDA, EMEA, ICH).
Clinical Expertise:
- Pre-clinical PK and toxicokinetics (GLP-compliant)
- Bioequivalence and comparative bioavailability
- ADME Clinical Studies (C14 studies)
- Modified release formulations
- Transdermal drug delivery
- Inhaled drugs
- Immunological response
- PD profiling of pharmacological effects, including a large range of biomarkers
Pharmacokinetic & Pharmacodynamic Analysis
SGS' pharmacokineticists have on average over 10 years' experience.
The following services:
- Preclinical Development
- Evaluation of safety data and animal tissue distribution data
- Study design: sample size calculation, optimized sampling schedule
- PK/PD input into the protocol and the SAP
- Patient recruitment and study execution in own Phase I Clinical Research Unit
- PK/PD Modeling and simulation
- Noncompartmental and compartmental analysis
- Population PK/PD modeling (including covariates assessment)
- Pooled analysis
- Development of a specific PK/PD analysis plan on request
- Statistical analysis of PK and PD outcomes
- Standalone PK/PD report
- PK/PD input into the Clinical Study Report
- Preparation of scientific publications and investigator brochures
- Design and interpretation of single or repeated rising-dose studies as well as PET scan studies, relative bioavailability studies and PK studies in renal insufficiency or hepatic insufficiency patients.
Software tools:
- WinNonlin®
- NonNem®
- Sigmaplot facilities, for macro creation and statistical reporting
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