Clinical Pharmacokinetics & Pharmacodynamics

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 (14C 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