Pharmacogenetics in Early Stage Clinical Trials: Accelerating Drug Characterization for Improved Development Outcomes

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eBulletin  |  March 2014

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Pharmacogenetics in Early Stage Clinical Trials:
Accelerating Drug Characterization for Improved Development Outcomes

Key drug characterization data can be obtained earlier in clinical development by investigating the impact of genetic variability in metabolic pathways on pharmacokinetic (PK) profiles. This can lead to a better understanding of the absorption, distribution and excretion properties from a new drug which can be used to develop individual response profiles to better predict safety and efficacy in later stage trials. As a result, later stage trials can be more efficient which significantly reduces the total drug development costs.

In a recent program, Algorithme Pharma successfully assessed the genetic impact on plasma concentrations from 2 drugs which were extensively metabolized in the liver by the cytochrome P450 into their metabolite(s). This assessment was complemented with the generation of pharmacokinetic (PK) profiles of each subject. The results demonstrated a significant genotypic & phenotypic heterogeneity influence on the drug pharmacokinetics and provided the sponsor with key information early in the development process.

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By integrating Pharmacogenetics early in clinical development, Algorithme Pharma can evaluate personalized drug peak concentrations, drug exposure and elimination. This provides sponsors with more reliable pharmacokinetic characterization which allows for earlier decision-making and improved development outcomes.

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