TechnoSTAT Clinical Services 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 biostatisticians provide full support to your PK study needs, including the following services:

  • Pharmacokinetic literature review
  • PK study sample size calculations 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 biostatistical 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.

We make it Professional - contact us

Address: 17 Metsada Street, 12th Floor , Bnei Brak, 5120118. Israel

Tel: +972-9-7669333 

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