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Concurrent toxicokinetic analysis was conducted to characterize the toxicokinetic profile and placental transfer of YWS1903.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Aside from hair loss at the highest dose, no significant maternal toxicity was observed up to 200\u2009mg\u2009kg<jats:sup>\u22121<\/jats:sup>. Fetal assessments revealed reductions in body weight and crown\u2010rump length at 200\u2009mg\u2009kg<jats:sup>\u22121<\/jats:sup>, alongside increased skeletal malformations, but no visceral abnormalities were detected. Toxicokinetic linearity studies revealed that within the 20\u2013200\u2009mg\u2009kg<jats:sup>\u22121<\/jats:sup> dose range, both <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub> and AUC<jats:sub>0\u2010t<\/jats:sub> of YWS1903 exhibited disproportionate increases following initial and final administrations. In the high\u2010dose group, the escalation in AUC<jats:sub>0\u2010t<\/jats:sub> substantially exceeded the corresponding dose changes, suggesting potential saturation of metabolic pathways at higher exposure levels. YWS1903 was shown to cross the placenta, although fetal plasma concentrations were consistently lower than maternal levels, suggesting reduced direct fetal exposure.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The no observed adverse effect level was established at 60\u2009mg\u2009kg<jats:sup>\u22121<\/jats:sup>, supporting the compound's safety at moderate doses. These findings provide valuable insights into YWS1903's developmental and reproductive safety profile and offer reference for its clinical application as a therapeutic agent for gastroesophageal reflux disease.<\/jats:p><\/jats:sec>","DOI":"10.1002\/bdr2.2481","type":"journal-article","created":{"date-parts":[[2025,5,7]],"date-time":"2025-05-07T05:08:35Z","timestamp":1746594515000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Embryo\u2010Fetal Developmental Toxicity and Toxicokinetics Studies of <scp>YWS1903<\/scp>, a Novel Potassium\u2010Competitive Acid Blocker, in Pregnant Rats"],"prefix":"10.1002","volume":"117","author":[{"given":"Chaoying","family":"Lu","sequence":"first","affiliation":[{"name":"School of Pharmaceutical Sciences Nanjing Tech University  Nanjing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3460-0883","authenticated-orcid":false,"given":"Hongqun","family":"Qiao","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences Nanjing Tech University  Nanjing China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,5,7]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000030487"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.4292\/wjgpt.v5.i3.105"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2019\u20100857"},{"key":"e_1_2_9_5_1","volume-title":"Clinical Physiology in Obstetrics","author":"Chamberlain G.","year":"1998"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1155\/2023\/7588085"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.4166\/kjg.2022.143"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1469\u2010185X.1951.tb00775.x"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.3109\/10520292609115636"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598\u2010018\u201030885\u2010w"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262\u2010015\u20100326\u20107"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl\u20102016\u2010313589"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088\u2010200847010\u201000001"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl\u20102016\u2010311715"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265\u2010015\u20100368\u2010z"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1155\/2009\/678514"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.heliyon.2023.e20406"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10620\u2010018\u20105122\u20104"},{"key":"e_1_2_9_19_1","unstructured":"ICH.2020.\u201cInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. 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