Clinical Pharmacology, Early Phase Development, First in Human Trial

By: Icon Clinical Research (canada)  09-12-2011
Keywords: Product Development

With expertise in early phase clinical research, bioanalytical, PK/PD modeling & simulation and the full range of supporting services, we incorporate scientific excellence and product development strategy in all that we do. Our multi-disciplinary experts have the experience to address the most demanding drug development challenges with an unyielding focus on completing projects on time, on budget and with the quality that will withstand the most vigorous scrutiny.

Key services include:

  • Product development consulting
  • Bioanalytical 
  • PK/PD Modelling and simulation 
  • Population PK 
  • Data Analysis (TK, PK, PK/PD)
  • Regulatory affairs strategy / submission 
  • Protocol design
  • Medical Writing 
  • Quality Control/Assurance 
  • Pharmacodynamic Models 
  • Clinical studies including: 
    • Food effect studies 
    • Dosage Regimen assessments 
    • Diabetic Clamp studies 
    • QTc studies 
    • First in man, dose escalation, PK/PD 
    • Multiple dose studies 
    • Drug interaction studies 
    • Bioavailability, bioequivilence 
    • Phase I patient studies 
    • Special population studies 
    • Patient studies 
    • Special population studies 
    • Proof of concept studies

Keywords: Product Development

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