Product/Service

ADME

Source: SGS Life Sciences Services
SGS' Life Science Services 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' Life Science Services 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' clinical, bioanalytical and specialized pharmacokinetics departments all work together to provide an integrated PK/PD solution.

Clinical Expertise

  • Pre-clinical PK and toxicokinetics (GLP-compliant if requested)
  • Bioequivalence and comparative bioavailability
  • First-in-man (with reduced turnaround for quick assessments between cohorts)
  • ADME evaluation (14C studies)
    • Over 50 ADME studies performed
  • Modified release formulations
  • Transdermal drug delivery
  • Inhaled drugs
  • Immunological response
  • PD profiling of pharmacological effects, including a large range of biomarkers

Clinical Facilities:

  • GCP-Compliant, FDA-inspected 162 beds Phase I Clinical Research Units
    • Rapid approval of studies (2 weeks in Belgium)
    • WHO/ICRP-category I and IIa studies generally accepted
    • Dedicated subunit for dose administration and sample collection
  • Dedicated and licensed GLP certified laboratories equipped with:
    • Sample oxidizer for treating difficult matrices and avoiding quenching
    • High sensitivity liquid scintillation counter (Packard Tri-Carb 3170 TR/SL)
    • Liquid scintillation analyzer (Packard Tri-Carb 2900 TR)
  • Dedicated facilities for preparation of clinical supplies (GMP-like)
  • Specialized laboratory for metabolic identification and profiling

Pharmacokinetics and Pharmacodynamics 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
  • PK/PD consulting: expert advising in drug development program, in Data Monitoring Committee

Software Tools:

  • WinNonlin Professional®
  • NonMEM®
  • Kinetica®
  • Watson LIMS®
  • nQuery Advisor® (sample size calculations)
  • SigmaPlot® (with developed macro for quick generation of standard graphs)
  • SAS®