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Enhancing value of clinical pharmacodynamics in oncology drug development: An alliance between quantitative

K Venkatakrishnan1, J A Ecsedy2

  • 1Quantitative Clinical Pharmacology, Takeda Pharmaceuticals International Co, Cambridge, Massachusetts, USA.

Clinical Pharmacology and Therapeutics
|November 3, 2016
PubMed

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The empirical approach to drug therapy optimization relies on correlating pharmacological response with administered dosage. Such an approach can be costly, time-consuming, and often yields poor correlation due to variables like formulation factors and drug elimination characteristics. A more precise approach correlates response with plasma drug concentration or the amount of drug in the body, rather than dosage. This is achieved through pharmacokinetic-pharmacodynamic (PK/PD) modeling, which...
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Pharmacodynamic (PD) responses describe the interaction between a drug and its biological target, culminating in a physiological effect. These responses can be classified into different types: continuous variables, such as blood glucose levels; categorical outcomes, like survival rates; and time-to-event metrics, such as disease progression. Understanding and modeling PD responses are critical for optimizing drug efficacy and safety.PD models describe the relationship between drug concentration...
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