Systems pharmacology to predict drug safety in drug development

Mirjam N Trame; Konstantinos Biliouris; Lawrence J Lesko; Jerome T Mettetal

doi:10.1016/j.ejps.2016.05.027

Systems pharmacology to predict drug safety in drug development

Eur J Pharm Sci. 2016 Oct 30:94:93-95. doi: 10.1016/j.ejps.2016.05.027. Epub 2016 May 29.

Authors

Mirjam N Trame¹, Konstantinos Biliouris², Lawrence J Lesko², Jerome T Mettetal³

Affiliations

¹ Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, University of Florida, Lake Nona, Orlando, FL, USA. Electronic address: [email protected].
² Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, University of Florida, Lake Nona, Orlando, FL, USA.
³ AstraZeneca, Drug Safety and Metabolism, Waltham, MA, USA.

PMID: 27251780
DOI: 10.1016/j.ejps.2016.05.027

Abstract

Ensuring that drugs are safe and effective is a very high priority for drug development and the US Food and Drug Administration review process. This is especially true today because of faster approval times and smaller clinical trials, especially in oncology and rare diseases. In light of these trends, systems pharmacology is seen as an essential strategy to understand and predict adverse drug events during drug development by analyzing interactions between drugs and multiple targets rather than the traditional "one-drug-one-target" approach. This commentary offers an overview of the current trends and challenges of using systems pharmacology to reduce the risks of unintended adverse events.

Keywords: Adverse drug events; Drug development; Drug safety; Systems pharmacology.

Publication types

Review

MeSH terms

Animals
Drug Discovery / methods
Drug Discovery / trends*
Drug-Related Side Effects and Adverse Reactions / diagnosis*
Forecasting
Humans
Pharmacology, Clinical / methods
Pharmacology, Clinical / trends*
Systems Biology / methods
Systems Biology / trends*