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How Can PK/PD Analysis Add Value to Patient Care?

In May 2011, T.J. Smith and B.E. Hillner published an opinion piece in the New England Journal of Medicine titled “Bending the Cost Curve in Cancer Care” (link). In this opinion piece, Smith and Hillner suggest that the rapidly increasing cost of treating cancer is not sustainable.

“We must find ways to reduce the costs of everyday care to allow more people and advances to be covered without bankrupting the health care system.”

Suggestions to re-balance the cost-effectiveness included limiting chemotherapy based on performance metrics, switching to palliative therapy when chances of success are small, having appropriate end-of-life discussions, and executing comparative-effectiveness and cost effectiveness analyses. These solutions are not novel or unique, but they challenge the standard method of treating patients.

This article made me think about my contributions and how I might contribute to reducing the cost burden on the healthcare system while continuing to provide the best possible therapies to patients. Pharmacokinetic/pharmacodynamic analysis should provide significant information to optimize therapy for patients, but I don’t think we have achieved that lofty goal. This discipline which we practice uses pharmacostatistical models to relate drug doses to clinical response information. As these models are developed, we include patient demographic information to refine the predictions and customize our models. We also link PK and PD together to create integrated exposure-response models that link dosing to clinical efficacy. Despite all of this effort, many of these PK/PD models never reach clinicians who prescribe the medications nor do they reach the patients who could benefit from our work.

What can we do to change this sad fact? Here are some of my ideas:

  • Integrate more clinically relevant features into our models. Focus on demographic measures commonly made in a physician’s office, not those measured in a clinical study.
  • Package our models into tools that physicians can use. Provide PK/PD models as web apps, mobile apps, or in conjunction with other physician software packages. Help physicians simplify the process of prescribing medication.
  • Provide our models to patients. Provide simplified models to patients as scientific communications, not promotional tools. Today’s patient is educated, curious, and connected to the internet. Let’s recognize that inquisitive nature and provide tools to help patients discuss their medication with their physician
  • Simplify our models and target clinical outcomes. Too many models focus on esoteric measures of pharmacodynamic measures. Let’s spend more time integrating clinical outcomes (even those that are categorical) into our models so that they can be more meaningful to physicians and patients.

What do you think we can do to use PK/PD to add value to patient care? Leave your comments below.

Every patient is different. Thus, they react to drugs in different ways. Precision dosing is a key step toward achieving the goals of precision medicine, a global objective supported by world leaders. The emerging precision dosing field harnesses the explosion of genomic data and various markers of bodily functions using mathematical modeling to ensure that individuals get the best possible treatment.

Watch our webinar to learn how modeling and simulation approaches support the goal of precision dosing—providing the right drug dose to maximize therapeutic benefit, while reducing risk for each individual patient.


Nathan Teuscher
By: Nathan Teuscher
Dr. Teuscher has been involved in clinical pharmacology and pharmacometrics work since 2002. He holds a PhD in Pharmaceutical Sciences from the University of Michigan and has held leadership roles at biotechnology companies, contract research organizations, and mid-sized pharmaceutical companies. Prior to joining Certara, Dr. Teuscher was an active consultant for companies and authored the Learn PKPD blog for many years. At Certara, Dr. Teuscher developed the software training department, led the software development of Phoenix, and now works as a pharmacometrics consultant. He specializes in developing fit-for-purpose models to support drug development efforts at all stages of clinical development. He has worked in multiple therapeutic areas including immunology, oncology, metabolic disorders, neurology, pulmonary, and more. Dr. Teuscher is passionate about helping scientists leverage data to aid in establishing the safety and efficacy of therapeutics.

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