Safety pharmacology 2023 and implementation of the ICH E14/S7B Q&A guidance document

Michael K Pugsley; Yevgeniya E Koshman; C Michael Foley; Brett R Winters; Simon Authier; Michael J Curtis

doi:10.1016/j.vascn.2023.107300

Safety pharmacology 2023 and implementation of the ICH E14/S7B Q&A guidance document

J Pharmacol Toxicol Methods. 2023 Sep-Oct:123:107300. doi: 10.1016/j.vascn.2023.107300. Epub 2023 Jul 29.

Authors

Michael K Pugsley¹, Yevgeniya E Koshman², C Michael Foley², Brett R Winters³, Simon Authier⁴, Michael J Curtis⁵

Affiliations

¹ Toxicology & Safety Pharmacology, Cytokinetics, South San Francisco, CA 94080, USA. Electronic address: mpugsley@cytokinetics.com.
² Safety Pharmacology, Abbvie, North Chicago, IL 60064, USA.
³ Toxicology & Safety Pharmacology, Cytokinetics, South San Francisco, CA 94080, USA.
⁴ Charles River Laboratories, Laval, QC H7V 4B3, Canada.
⁵ Cardiovascular Division, King's College London, Rayne Institute, St Thomas' Hospital, London SE17EH, UK.

PMID: 37524151
DOI: 10.1016/j.vascn.2023.107300

Abstract

This editorial prefaces the annual themed issue on safety pharmacology (SP) methods published since 2004 in the Journal of Pharmacological and Toxicological Methods (JPTM). We highlight here the content derived from the recent 2022 Safety Pharmacology Society (SPS) and Canadian Society of Pharmacology and Therapeutics (CSPT) joint meeting held in Montreal, Quebec, Canada. The meeting also generated 179 abstracts (reproduced in the current volume of JPTM). As in previous years the manuscripts reflect various areas of innovation in SP including a comparison of the sensitivity of cross-over and parallel study designs for QTc assessment, use of human-induced pluripotent stem cell (hi-PSC) neuronal cell preparations for use in neuropharmacological safety screening, and hiPSC derived cardiac myocytes in assessing inotropic adversity. With respect to the latter, we anticipate the emergence of a large data set of positive and negative controls that will test whether the imperative to miniaturize, humanize and create a high throughput process is offset by any loss of precision and accuracy.

Keywords: Cardiac ionotropy; Cardiac safety; Human-induced pluripotent stem cell; ICH E14/S7B Q&A; Neuronal stem cells; Safety pharmacology.

Publication types

Editorial

MeSH terms

Canada
Congresses as Topic
Drug Evaluation, Preclinical / methods
Drug-Related Side Effects and Adverse Reactions* / prevention & control
Humans
Pharmacology* / methods