Methodological and technological advances in safety pharmacology - New or simply nuanced?

Michael K Pugsley; Tessa de Korte; Venkatesha Udupa; Simon Authier; Michael J Curtis

doi:10.1016/j.vascn.2019.106604

Methodological and technological advances in safety pharmacology - New or simply nuanced?

J Pharmacol Toxicol Methods. 2019 Sep-Oct:99:106604. doi: 10.1016/j.vascn.2019.106604. Epub 2019 Jun 27.

Authors

Michael K Pugsley¹, Tessa de Korte², Venkatesha Udupa³, Simon Authier⁴, Michael J Curtis⁵

Affiliations

¹ Cytokinetics, South San Francisco, CA 94080, USA. Electronic address: mpugsley@cytokinetics.com.
² Ncardia, Leiden 2333, BD, the Netherlands; Dept. of Anatomy and Embryology, Leiden University Medical Center, 2333, ZD, Leiden, the Netherlands.
³ Glenmark Pharmaceuticals Limited, Navi Mumbai 400709, India.
⁴ CiToxLAB Research Inc., Laval, QC H7V 4B3, Canada.
⁵ Cardiovascular Division, Rayne Institute, St Thomas' Hospital, London SE17EH, UK.

PMID: 31254621
DOI: 10.1016/j.vascn.2019.106604

Abstract

This editorial previews and summarizes the content of the current themed issue of J Pharm Tox Methods derived from the recent 2018 Annual Safety Pharmacology Society (SPS) meeting held in Washington, DC. The papers highlight improvements in methods and study endpoints used in non-clinical safety pharmacology (SP) to enhance clinical translatability. Articles cover areas including the SP assessment of oligonucleotides and gene therapy, core battery clinical translation case studies, next generation non-opiate pain management strategy, aspects of cardio-oncology that extend the traditional objectives of an SP assessment, real-world advanced imaging techniques used in preclinical safety, in silico approaches including mathematical modeling, machine learning, and bioinformatics and how secondary SP studies impact clinical trial interpretation and design. The meeting included scientific content from >190 abstracts (reproduced in the current volume of J Pharm Tox Methods).

Publication types

Editorial