Pharmacokinetics

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.