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The Critical Role of PK/PD in the Development of Anticancer Agents

by Scientific Writing Team

Understanding drug pharmacokinetics (PK) and metabolism has always been a critical requirement of drug development.  However, the way in which the body handles drug absorption, distribution, metabolism and excretion is of even greater importance in oncology because disease status can dramatically alter these processes.  In addition to affecting function of the liver and kidney, solid tumors can generate a defective vasculature that impacts drug exposure. As a result, plasma PK may not be a good surrogate for tumor PK.  This is one of many reasons for the particularly poor success rate for oncology drugs [1].  Of note, many of the newer antitumor agents are antibody-based or employ nano-carrier/encapsulation technologies, which enable isotopic or optical labeling and hence tumor imaging and the associated tumor pharmacokinetics.

The emergence of targeted anticancer therapy has also led to a recent emphasis on drug pharmacodynamics (PD).  The Food and Drug Administration has increasingly encouraged co-development of the respective biomarkers to document drug response.  Preclinical modeling of PK/PD relationships is therefore central to clinical translation including optimal patient selection and replacement of toxicity endpoints with modulation of specific molecular drug targets to assess clinical response.

In summary, in-depth design and analysis of PK/PD studies by Nuventra professionals can significantly enhance rational development of novel anticancer therapies.

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[1] Adams D: The Valley of Death in anticancer drug development – a re-assessment. Trends in Pharmacological Sciences 2012, 33(4):172-180.