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A Smarter Way to do PK/PD Part 6 – PK/PD Sampling Schedule

This series of blog posts describes the benefits of using Nuventra’s Pharmacokineticists to meet your PK/PD needs for drug development. This post focuses on how to get an optimal PK/PD Sampling Schedule.

A PK/PD Sampling Schedule Issue Rescued by Nuventra

  • For studies of intravenously (IV) administered compounds, obtaining a blood sample for PK analysis immediately prior to discontinuation of infusion is important since this is typically the Cmax and Tmax for the drug.  Drug concentration declines rapidly after infusion is stopped.  If samples are taken too early or too late relative to infusion termination then the concentration versus time profile will not be as informative as it could be, leading to less than optimal PK parameters.
  • The mechanism for infusion is also an important consideration, with timed administration of a fixed concentration and flow rate to deliver a precise dose preferable to administration of a fixed volume.
  • Nuventra rescued a project where the client initially attempted to deliver a fixed volume by a combination of infusion plus gravity flow.  This would have resulted in an unknown dose being delivered using two different flow rates, and would have made PK analysis and interpretation difficult.  We were asked to join the team and immediately identified the issue followed by corrective recommendations for future cohorts in the ascending dose study.

Take home message

Every drug program needs an experienced Pharmacokineticist to help design studies, oversee the collection of PK samples, evaluate PK data, describe the PK characteristics of a drug, and plan for next steps in a drug development program.

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