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Consulting and training
for your clinical development

PK/PD modelling and simulation

We design, plan, analyze and report:

  • FTIM, single dose PK, metabolic, PD (markers, surrogates),
  • Absolute bioavailability, bioequivalence,
  • Repeat-dose PK, dose-proportionality,
  • Drug, food or disease interaction studies.

We perform PK and PK/PD analyses:

  • Non-compartmental PK analysis,
  • Individual modeling
  • Population PK/PD modeling,
  • Clinical trial simulations,

We design PK screens for the integration of population PK in phase IIa to phase II (target population):

  • To describe sources of variability,
  • To support dose-selection,
  • For pediatric submissions,
  • To bridge across formulations or regions.

We realize post-hoc pooled data-analyses:

  • To answer queries regarding the integrated dose-concentration-response
  • To refine the dose selection.

We provide support for study placement, site monitoring, auditing and data clarification.

With full integrated cooperation with our mother house, PhinC Development, we advise you on preclinical phase. We design, analyze and report pre-clinical PK and/or PD, in vitro or ex vivo studies to support clinical development. We use preclinical data to extrapolate exposure and response in human and choose initial doses for FIM (First In Men).

We can advise on the requirements for the bioanalytical methods at different stages of development.

 

Need more information about our PK/PD Modelling and Simulation services ? We will be glad to help you.