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 Pharmacolo...
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Veröffentlicht in: | Journal of pharmacological and toxicological methods 2023-09, Vol.123, p.107300-107300, Article 107300 |
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container_title | Journal of pharmacological and toxicological methods |
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creator | Pugsley, Michael K. Koshman, Yevgeniya E. Foley, C. Michael Winters, Brett R. Authier, Simon Curtis, Michael J. |
description | 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. |
doi_str_mv | 10.1016/j.vascn.2023.107300 |
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Michael ; Winters, Brett R. ; Authier, Simon ; Curtis, Michael J.</creator><creatorcontrib>Pugsley, Michael K. ; Koshman, Yevgeniya E. ; Foley, C. Michael ; Winters, Brett R. ; Authier, Simon ; Curtis, Michael J.</creatorcontrib><description>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.</description><identifier>ISSN: 1056-8719</identifier><identifier>EISSN: 1873-488X</identifier><identifier>DOI: 10.1016/j.vascn.2023.107300</identifier><identifier>PMID: 37524151</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Cardiac ionotropy ; Cardiac safety ; Human-induced pluripotent stem cell ; ICH E14/S7B Q&A ; Neuronal stem cells ; Safety pharmacology</subject><ispartof>Journal of pharmacological and toxicological methods, 2023-09, Vol.123, p.107300-107300, Article 107300</ispartof><rights>2023</rights><rights>Copyright © 2023. Published by Elsevier Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c359t-ab4ad5ffa9bf089549ffb271add4624bf9b8307772a96c6a4c8894ff9e8a6d083</citedby><cites>FETCH-LOGICAL-c359t-ab4ad5ffa9bf089549ffb271add4624bf9b8307772a96c6a4c8894ff9e8a6d083</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.vascn.2023.107300$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37524151$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pugsley, Michael K.</creatorcontrib><creatorcontrib>Koshman, Yevgeniya E.</creatorcontrib><creatorcontrib>Foley, C. Michael</creatorcontrib><creatorcontrib>Winters, Brett R.</creatorcontrib><creatorcontrib>Authier, Simon</creatorcontrib><creatorcontrib>Curtis, Michael J.</creatorcontrib><title>Safety pharmacology 2023 and implementation of the ICH E14/S7B Q&A guidance document</title><title>Journal of pharmacological and toxicological methods</title><addtitle>J Pharmacol Toxicol Methods</addtitle><description>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.</description><subject>Cardiac ionotropy</subject><subject>Cardiac safety</subject><subject>Human-induced pluripotent stem cell</subject><subject>ICH E14/S7B Q&A</subject><subject>Neuronal stem cells</subject><subject>Safety pharmacology</subject><issn>1056-8719</issn><issn>1873-488X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNp9kE1LxDAQhoMofqz-AkFyEi9dkyZtkoMHXfyCBREVvIVpPjRL26xNK-y_t-uqR08zDM_M8D4IHVMypYSW54vpJyTTTnOSs3EiGCFbaJ9KwTIu5ev22JOizKSgag8dpLQghDBF-S7aY6LIOS3oPnp-Au_6FV6-Q9eAiXV8W-H1RQytxaFZ1q5xbQ99iC2OHvfvDt_P7vA15edP4go_nl7ityFYaI3DNpphTR-iHQ91ckc_dYJebq6fZ3fZ_OH2fnY5zwwrVJ9BxcEW3oOqPJGq4Mr7KhcUrOVlziuvKsmIECIHVZoSuJFSce-Vk1BaItkEnW3uLrv4MbjU6yYk4-oaWheHpHPJeSkJV_mIsg1quphS57xedqGBbqUp0WudeqG_dep1eL3ROW6d_DwYqsbZv51ffyNwsQHcGPMzuE4nE9zowobOmV7bGP598AUdF4Us</recordid><startdate>20230901</startdate><enddate>20230901</enddate><creator>Pugsley, Michael K.</creator><creator>Koshman, Yevgeniya E.</creator><creator>Foley, C. 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subjects | Cardiac ionotropy Cardiac safety Human-induced pluripotent stem cell ICH E14/S7B Q&A Neuronal stem cells Safety pharmacology |
title | Safety pharmacology 2023 and implementation of the ICH E14/S7B Q&A guidance document |
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