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

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.

Automated summary

This editorial introduces the annual themed issue on safety pharmacology methods published in the Journal of Pharmacological and Toxicological Methods since 2004. It highlights the content derived from the recent joint meeting of the Safety Pharmacology Society and the Canadian Society of Pharmacology and Therapeutics in Montreal, Canada. The meeting generated 179 abstracts, which are included in the current volume of the journal. The manuscripts reflect various areas of innovation in safety pharmacology, including the comparison of different study designs for QTc assessment, the use of hiPSC neuronal cell preparations for neuropharmacological safety screening, and the evaluation of inotropic adversity using hiPSC derived cardiac myocytes.