Data Services

Extensive pharmacokinetic (PK) and pharmacodynamic (PD) support

Empower your clinical trials with informed decisions using our expert PK/PD Services

Strategic planning of your clinical trials is possible through effective pharmacokinetic (PK) and pharmacodynamics (PD) studies. Pharmacokinetics is the study of the movement of the drug through the body while pharmacodynamics is the body’s response to the drugs. An understanding of (PK/PD) response is vital for drug development and approval. This information contributes significantly to the information found in drug packet inserts.

Navitas Data Sciences is your PK/PD Expert

Your clinical trials will be efficiently supported in accordance with International regulatory standards by our extensive pharmacokinetic (PK) and pharmacodynamic (PD) support.

Expert End-to-End PK/PD services

During clinical trials, PK data are received from multiple sources and using different standards. In some cases, units of measurement are different, and the results must be converted and labeled with the standard units. At Navitas Data Sciences, we standardize the results of the analysis and store it as SAS® datasets using standard CDISC-compliant structure. Our expert clinical SAS programmers have years of experience managing and transforming PK/PD trial data into CDISC-compliant tables, listings, and figures for successful FDA submission.

Stay CDISC ADNCA compliant with our stellar PK/PD support

The data that is required for PK parameter software is a combination of several datasets. An SDTM convention like PC (Pharmacokinetic Concentrations) would not meet the necessary requirements for this analysis. In addition, the required data structure is more complicated than the currently defined ADaM BDS structure. As a result, the ADaM leadership team is developing standards that closely follow current ADaM guidance while allowing flexibility to work with various types of software packages used to analyze PK data.
ADNCA is the result of this sub-teams’ effort. ADNCA is still in review following the development process for CDISC standards. Navitas Data Sciences is closely following the development of this much-needed new standard. When it is released, our programming team will be ready to lead the industry.

Get the Navitas Advantage

  • Characterizing drug exposure
  • Identifying dosage requirements
  • Assessing changes to dosage requirements
  • Estimation of rate of absorption and rate of elimination
  • Characterizing intra- and inter-subject variability
  • Identifying concentration-effect relationships
  • Assessing efficacy characteristics