Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2021 Sep-Oct:111:107089.
doi: 10.1016/j.vascn.2021.107089. Epub 2021 Jun 26.

Safety pharmacology during the COVID pandemic

Affiliations
Editorial

Safety pharmacology during the COVID pandemic

Michael K Pugsley et al. J Pharmacol Toxicol Methods. 2021 Sep-Oct.

Abstract

This editorial summarizes the content of the current themed issue of J Pharmacol Toxicol Methods derived from the 2020 Annual Safety Pharmacology Society (SPS) meeting that was held virtually September 14-17, 2020 due to the ongoing COVID-19 global pandemic. A selection of articles arising from the virtual meeting is summarized. Like previous years they continue to reflect current areas of innovation in SP including new methodologies to predict human safety, best practices for IKr current measurement, and best practice considerations for the conduct of in vivo nonclinical QT studies. The meeting included scientific content from 94 abstracts (reproduced in the current volume of J Pharmacol Toxicol Methods). This continued innovation reflects a rubric in SP that identifies problems, seeks solutions and, importantly, validates the solutions.

PubMed Disclaimer

Conflict of interest statement

Declaration of Competing Interest None of the authors have any conflicts of interest, other than employment at either a contract research organization (SA), a biotech company (TdeK) or a pharmaceutical company (MKP, YK).

Figures

Fig. 1
Fig. 1
An overview of publication trends for safety pharmacology manuscripts published in the annual focused issue of the Journal of Pharmacological & Toxicological Methods. Included are the total number of articles published each year since 2004 and content. The trends for papers were segregated based upon content and whether it involved core battery studies, i.e., the CNS, CV or respiratory systems. Content is also shown for human induced pluripotent cardiac stem cells (hiPSC-CMs), the Comprehensive in vitro Proarrhythmia Assay (CiPA), in silico modeling methods and Supplemental Safety Pharmacology studies (i.e., Renal or GI studies) surveys and animal welfare studies.

References

    1. Amouzadeh H.R., Dimery I., Werner J., Ngarmchamnanrith G., Engwall M.J., Vargas H.M., Arrindell D. Clinical implications and translation of an off-target pharmacology profiling hit: Adenosine uptake inhibition in vitro. Translational Oncology. 2019;12:1296–1304. doi: 10.1016/j.tranon.2019.05.018. - DOI - PMC - PubMed
    1. Antzelevitch C., Sicouri S., Di Diego J.M., Burashnikov A., Viskin S., Shimizu W.…Zhang L. Does Tpeak-Tend provide an index of transmural dispersion of repolarization? Heart Rhythm. 2007;4:1114–1116. - PMC - PubMed
    1. Authier S., Pugsley M.K., Troncy E., Curtis M.J. In: Predictive approaches in drug discovery & development: biomarkers and in vitro/in vivo correlations. Williams J.A., Lalonde R., Koup J.R., Christ D.D., editors. Wiley Interscience; Hoboken, NJ, USA: 2013. Cardiovascular biomarkers as examples of success and failure in predicting safety in humans.
    1. Baldrick P. Core battery safety pharmacology testing - An assessment of its utility in early drug development. Journal of Pharmacological and Toxicological Methods. 2021;109:107055. doi: 10.1016/j.vascn.2021.107055. May-Jun. - DOI - PubMed
    1. Banker J., Dizon J., Reiffel J. Effects of the ventricular activation sequence on the JT interval. American Journal of Cardiology. 1997;79 826–819. - PubMed