{"title":"Validation of QPCR method to detect human cells in mouse and rat tissues","authors":"Kuniyoshi Abe, Haruka Inoue, Yuka Torikai, Naoki Kaname, Seulgi Lee, Akiko Suzuki, Yukiko Arimura, Yurie Okawa, Tetsuya Yoshikawa","doi":"10.1016/j.dmpk.2025.101143","DOIUrl":"10.1016/j.dmpk.2025.101143","url":null,"abstract":"","PeriodicalId":11298,"journal":{"name":"Drug Metabolism and Pharmacokinetics","volume":"61 ","pages":"Article 101143"},"PeriodicalIF":2.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144195332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Why and when do i use PBPK modeling","authors":"Kunal Taskar","doi":"10.1016/j.dmpk.2025.101060","DOIUrl":"10.1016/j.dmpk.2025.101060","url":null,"abstract":"","PeriodicalId":11298,"journal":{"name":"Drug Metabolism and Pharmacokinetics","volume":"61 ","pages":"Article 101060"},"PeriodicalIF":2.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144195347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Species specificity and selection of animal models for drug oxygenations differently contributed by polymorphic human enzymes","authors":"Hiroshi Yamazaki","doi":"10.1016/j.dmpk.2025.101105","DOIUrl":"10.1016/j.dmpk.2025.101105","url":null,"abstract":"","PeriodicalId":11298,"journal":{"name":"Drug Metabolism and Pharmacokinetics","volume":"61 ","pages":"Article 101105"},"PeriodicalIF":2.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144195548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Suguru Asaji , Yuta Funai , Yuta Seki , Kotone Banba , Jun Hida , Ikumi Tamai , Yoshiyuki Shirasaka
{"title":"Drug-induced gastrointestinal toxicity due to disruption of the interinfluence between serotonin and gut microbiota","authors":"Suguru Asaji , Yuta Funai , Yuta Seki , Kotone Banba , Jun Hida , Ikumi Tamai , Yoshiyuki Shirasaka","doi":"10.1016/j.dmpk.2025.101121","DOIUrl":"10.1016/j.dmpk.2025.101121","url":null,"abstract":"","PeriodicalId":11298,"journal":{"name":"Drug Metabolism and Pharmacokinetics","volume":"61 ","pages":"Article 101121"},"PeriodicalIF":2.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144194038","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Preclinical DDI risk assessment in drug discovery and development","authors":"Niresh Hariparsad","doi":"10.1016/j.dmpk.2025.101080","DOIUrl":"10.1016/j.dmpk.2025.101080","url":null,"abstract":"","PeriodicalId":11298,"journal":{"name":"Drug Metabolism and Pharmacokinetics","volume":"61 ","pages":"Article 101080"},"PeriodicalIF":2.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144194033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"In vitro liver models for toxicological research","authors":"Ichiro Fukunaga , Takanori Takebe","doi":"10.1016/j.dmpk.2025.101478","DOIUrl":"10.1016/j.dmpk.2025.101478","url":null,"abstract":"<div><div>Drug-induced liver injury (DILI) presents a major challenge not only in new drug development but also in post-marketing withdrawals and the safety of food, cosmetics, and chemicals. Experimental model organisms such as the rodents have been widely used for preclinical toxicological testing. However, the tension exists associated with the ethical and sustainable use of animals in part because animals do not necessarily inform the human-specific ADME (adsorption, dynamics, metabolism and elimination) profiling. To establish alternative models in humans, in vitro hepatic tissue models have been proposed, ranging from primary hepatocytes, immortal hepatocytes, to the development of new cell resources such as stem cell-derived hepatocytes. Given the evolving number of novel alternative methods, understanding possible combinations of cell sources and culture methods will be crucial to develop the context-of-use assays. This review primarily focuses on 3D liver organoid models for conducting. We will review the relevant cell sources, bioengineering methods, selection of training compounds, and biomarkers towards the rationale design of in vitro toxicology testing.</div></div>","PeriodicalId":11298,"journal":{"name":"Drug Metabolism and Pharmacokinetics","volume":"62 ","pages":"Article 101478"},"PeriodicalIF":2.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143799927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Review of finalized ICH M12 guideline on drug interaction studies","authors":"Akihiro Ishiguro","doi":"10.1016/j.dmpk.2025.101079","DOIUrl":"10.1016/j.dmpk.2025.101079","url":null,"abstract":"","PeriodicalId":11298,"journal":{"name":"Drug Metabolism and Pharmacokinetics","volume":"61 ","pages":"Article 101079"},"PeriodicalIF":2.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144194034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A tale of preclinical insights into bile salt homeostasis disruption in DILI","authors":"Yurong Lai","doi":"10.1016/j.dmpk.2025.101108","DOIUrl":"10.1016/j.dmpk.2025.101108","url":null,"abstract":"","PeriodicalId":11298,"journal":{"name":"Drug Metabolism and Pharmacokinetics","volume":"61 ","pages":"Article 101108"},"PeriodicalIF":2.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144194667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Current status of Imaging Mass Spectrometry in drug discovery and development: A survey highlighting technical challenges and future directions","authors":"Yukari Tanaka , Hiroyuki Yokoi , Hidefumi Kaji , Yoko Urasaki , Masanobu Nishidate , Shin-ichiro Nitta , Kenichi Watanabe , Tomomi Ishida , Kouji Tanaka , Rika Komatsu , Kenji Yoshida , Kosuke Saito , Yoshiro Saito , Hiroshi Yamazaki","doi":"10.1016/j.dmpk.2025.101485","DOIUrl":"10.1016/j.dmpk.2025.101485","url":null,"abstract":"<div><div>Imaging mass spectrometry (IMS) is used in various fields of pharmaceutical research and development, including the targeted delivery of administered drugs, drug distribution in tissues, drug toxicity analysis, and disease mechanisms. However, IMS is a relatively new technology that requires further validation before being accepted by authorities for regulatory compliance of new drugs. In 2020, an international survey was conducted in collaboration with the Imaging Mass Spectrometry Society (IMSS) and the Japan Association for Imaging Mass Spectrometry (JAIMS) to understand the status of IMS and to identify problems with its application. The survey revealed technical challenges in sample preparation, quantitative analysis of drugs in tissues, and data acquisition. Based on the 2020 survey results, we recently conducted a further detailed survey and had discussions within the JAIMS aimed at translating the results into specific experimental procedures and proposing feasible standard methods. This survey involved detailed questions on five themes: sample collection and storage, tissue section preparation, sample preparation, data analysis (including quantitative analysis and data correction methods), and data reproducibility. The questions were answered by JAIMS members working for ten companies. To resolve technical issues identified by the survey, we propose some realistic approaches toward standardization.</div></div>","PeriodicalId":11298,"journal":{"name":"Drug Metabolism and Pharmacokinetics","volume":"62 ","pages":"Article 101485"},"PeriodicalIF":2.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143935162","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Role of intracellular SLC46A3 in the cytosolic exposure and pharmacological effect of the payload of trastuzumab emtansine (ADC)","authors":"Katsuhisa Inoue","doi":"10.1016/j.dmpk.2025.101095","DOIUrl":"10.1016/j.dmpk.2025.101095","url":null,"abstract":"","PeriodicalId":11298,"journal":{"name":"Drug Metabolism and Pharmacokinetics","volume":"61 ","pages":"Article 101095"},"PeriodicalIF":2.7,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144194937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}