Integration of Pharmacogenomics and Pharmacometrics to Support Drug Development, Regulatory and Therapeutic Decisions

ISSN: 1875-6913 (Online)
ISSN: 1875-6921 (Print)

Volume 15, 2 Issues, 2017

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Current Pharmacogenomics and Personalized Medicine

Formerly: Current Pharmacogenomics

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Adrián LLerena, MD, Ph.D
Extremadura University
Hospital and Medical School
Badajoz, Extremadura

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Integration of Pharmacogenomics and Pharmacometrics to Support Drug Development, Regulatory and Therapeutic Decisions

Current Pharmacogenomics and Personalized Medicine, 12(1): 32-42.

Author(s): Mukul Minocha, Sagar Shukla and Jogarao Gobburu.

Affiliation: Center for Translational Medicine, University of Maryland Baltimore, School of Pharmacy, 20N Pine Street, Baltimore, 21021, USA.


Pharmacogenomics as a science aims at individualizing the treatment based on the genetic makeup, to mitigate the chances of adverse drug events and/or to maximize the efficacy in a sub-population. Pharmacometrics is the science of quantifying disease, drug and trial characteristics with the goal to influence key drug development, regulatory and therapeutic decisions. Pharmacometric analysis as a tool has revolutionized the way dose/dosing regimens or clinical trials are being designed prospectively to answer key drug development questions. Exposure-response relationships established in adult patients have made it possible to make dosing recommendations in special populations (pediatrics and organ function impaired patients), leading to approval of doses/dosing regimen that were not studied in registration trials. Until now, pharmacogenomics is predominantly used retrospectively to understand the between subject variability of drug’s pharmacokinetic and pharmacodynamic properties. In this article we discuss how the advent of advanced pharmacometric tools can leverage prior pharmacogenomic information to prospectively design late stage clinical trials. In addition, selected case studies are presented that demonstrates the application of modeling and simulation in supporting dose selection in patients with allelic variants across different therapeutic areas.


Clinical-trial, modeling and simulation, drug-development, pharmacokinetics, pharmacodynamics, pharmacometrics, pharmacogenetics.

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Article Details

Volume: 12
Issue Number: 1
First Page: 32
Last Page: 42
Page Count: 11
DOI: 10.2174/1875692112666140315005909
Global Biotechnology Congress 2017Drug Discovery and Therapy World Congress 2017

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