Pharmacokinetics

TechnoSTAT specializes in pharmacokinetic (PK) analyses for evaluating the life cycle of drugs within the body.  From pre-clinical and phase I PK evaluations to later phase population PK analyses, TechnoSTAT provides full support to your PK study needs, including the following services:

  • Pharmacokinetic literature review
  • PK study sample size estimation to achieve pre-specified power demonstrating that the estimated clearance and volume of distribution satisfy that required by the regulatory body’s precision
  • Assistance with PK study design, including simulations allowing to estimate the potential effect of different factors like dose regimens and routes of administration
  • Writing a PK statistical analysis plan
  • Non-compartmental PK analysis
  • Compartmental PK analyses using non-linear mixed models
  • Pharmacokinetic reporting and interpretation in accordance with regulatory requirements
  • SAS-based analyses, enabling easy transfer of data into submission-ready packages in CDISC format, including both SDTM and ADaM domains