Our talented and experienced team can assist in all Clinical Study Phases (Phase 0, I, II and III) and in study designs ranging from First in Human (FIH), Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Drug-Drug Interaction (DDI), Bioavailability/Bioequivalence (BA/BE), Food Effect as well as Special Population studies. 

Novotech offers leading world class pharmacometric services:

  • Consultancy for study and/or protocol design
  • PK/PD analyses input in the preparation of the SAP or stand-alone pharmacokinetic analysis plan
  • PK/PD Analysis:
    • Non-compartmental PK analysis using Phoenix WinNonlin® software
    • PK/PD compartmental modelling using Phoenix NLME® software
    • Population (non-linear mixed effect modelling) PK/PD analyses using NONMEM® or Phoenix NLME® software
    • Modelling and simulation for the prediction of FIH dose selection
    • Writing PK/PD for Clinical Study Reports (CSR) or Standalone Pharmacokinetic Study Reports
  • Safety review meetings: Consultation and preparation of short turnaround PK Memos for FIH studies