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第 7 回 日本臨床薬理学会 東海・北陸地方会を終えて 第7届日本临床药理学会东海·北陆地方会结束后
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS Pub Date : 2023-09-30 DOI: 10.3999/jscpt.54.5_213
Kazunao KONDO
{"title":"第 7 回 日本臨床薬理学会 東海・北陸地方会を終えて","authors":"Kazunao KONDO","doi":"10.3999/jscpt.54.5_213","DOIUrl":"https://doi.org/10.3999/jscpt.54.5_213","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":"37 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135083336","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pharmacokinetics and Safety of Tucatinib in Healthy Japanese and Caucasian Volunteers: Results From a Phase Ⅰ Study 图卡替尼在健康日本和高加索志愿者中的药代动力学和安全性:来自Ⅰ期研究的结果
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS Pub Date : 2023-09-30 DOI: 10.3999/jscpt.54.5_187
Ariel TOPLETZ-ERICKSON, Anthony LEE, JoAl Garrido MAYOR, Hsu-Tai LIU, Layth Imad ABDULRASOOL, Luke WALKER, Christopher James ENDRES
{"title":"Pharmacokinetics and Safety of Tucatinib in Healthy Japanese and Caucasian Volunteers: Results From a Phase Ⅰ Study","authors":"Ariel TOPLETZ-ERICKSON, Anthony LEE, JoAl Garrido MAYOR, Hsu-Tai LIU, Layth Imad ABDULRASOOL, Luke WALKER, Christopher James ENDRES","doi":"10.3999/jscpt.54.5_187","DOIUrl":"https://doi.org/10.3999/jscpt.54.5_187","url":null,"abstract":"Tucatinib is a highly selective human epidermal growth factor receptor 2 (HER2) -directed tyrosine kinase inhibitor approved in multiple countries for metastatic HER2-positive breast cancer and in the US for metastatic HER2-postive metastatic colorectal cancer. This phase Ⅰ study (N＝36) compared the pharmacokinetic (PK) and safety profiles of tucatinib administered at 50-, 150-, and 300-mg doses taken twice daily orally in healthy Japanese (n＝18［n＝6 per tucatinib dose cohort］) and Caucasian volunteers (n＝18［n＝6 per tucatinib dose cohort］) to assess ethnicity effects on PK and dose proportionality of tucatinib. Ethnicity effects between both populations were evaluated using an analysis of covariance (ANCOVA) model and dose proportionality of tucatinib was assessed using a log-transformed linear regression model. Tucatinib steady-state exposure (AUCss) and maximum plasma concentration (Cmax) geometric mean values were similar between Japanese and Caucasian volunteers, with ANCOVA-adjusted geometric mean ratios (90％ confidence intervals) of 2.63 (1.04, 6.62), 1.11 (0.76, 1.62), and 1.33 (0.91, 1.95) for Cmax and 1.97 (0.85, 4.56), 1.05 (0.70, 1.58), and 1.04 (0.72, 1.49) for AUCss in the tucatinib 50-, 150-, and 300-mg cohorts, respectively. Thirty-three treatment-emergent adverse events (TEAEs) in 13 Caucasian volunteers and 2 TEAEs in 2 Japanese volunteers were reported. All TEAEs were grade 1, and the majority resolved by the end of study. At the approved therapeutic dose of 300 mg twice daily, tucatinib had a manageable safety profile and exposures were similar between Japanese and Caucasian volunteers. These findings indicate there is no need for dose alteration of tucatinib based on ethnicity.","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":"56 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135083147","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
2020 年度日本臨床薬理学会海外研修員報告： 研修完了報告書 2020 年度日本临床薬理学会海外研修员报告： 研修完了报告书
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS Pub Date : 2023-09-30 DOI: 10.3999/jscpt.54.5_207
Yasuhiro ARAKAWA
{"title":"2020 年度日本臨床薬理学会海外研修員報告： 研修完了報告書","authors":"Yasuhiro ARAKAWA","doi":"10.3999/jscpt.54.5_207","DOIUrl":"https://doi.org/10.3999/jscpt.54.5_207","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":"36 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135083332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
2021 年度日本臨床薬理学会海外研修員報告： 研修完了報告書 2021 年度日本临床薬理学会海外研修员报告： 研修完了报告书
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS Pub Date : 2023-09-30 DOI: 10.3999/jscpt.54.5_209
Kakei RYU
{"title":"2021 年度日本臨床薬理学会海外研修員報告： 研修完了報告書","authors":"Kakei RYU","doi":"10.3999/jscpt.54.5_209","DOIUrl":"https://doi.org/10.3999/jscpt.54.5_209","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":"31 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135083337","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Safety, Tolerability, and Pharmacokinetics of Belumosudil, a Selective Rho-associated Coiled-coil-containing Protein Kinase 2 Inhibitor, in Healthy Japanese Volunteers: A PhaseⅠ, Randomized, Controlled Trial 白莫硫地尔(一种选择性rho相关的含螺旋状蛋白激酶2抑制剂)在健康日本志愿者中的安全性、耐受性和药代动力学:Ⅰ期随机对照试验
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS Pub Date : 2023-09-30 DOI: 10.3999/jscpt.54.5_197
Yoichiro OGAMA, Hiroki SATO, Atsunori MIYATA, Koji KIJIMA, Yuji KUMAGAI
{"title":"Safety, Tolerability, and Pharmacokinetics of Belumosudil, a Selective Rho-associated Coiled-coil-containing Protein Kinase 2 Inhibitor, in Healthy Japanese Volunteers: A PhaseⅠ, Randomized, Controlled Trial","authors":"Yoichiro OGAMA, Hiroki SATO, Atsunori MIYATA, Koji KIJIMA, Yuji KUMAGAI","doi":"10.3999/jscpt.54.5_197","DOIUrl":"https://doi.org/10.3999/jscpt.54.5_197","url":null,"abstract":"Objective: To assess the safety, tolerability, and pharmacokinetics of belumosudil, a selective Rho-associated coiled-coil-containing protein kinase 2 inhibitor, in healthy Japanese male adults, a phase Ⅰ, randomized, double-blind, placebo-controlled trial was conducted.","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":"34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135083334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Patient Training Initiatives on Drug Development and Future Challenges：Developing a Social Infrastructure for Patient Engagement in Drug Development 药物开发和未来挑战的患者培训倡议:发展患者参与药物开发的社会基础设施
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS Pub Date : 2023-07-31 DOI: 10.3999/jscpt.54.4_173
Yuta Kasai, Kenma Nozaki, Nobutaka Yagi, Shintaro Omuro, Keiko Omomo, Kotone Matsuyama
{"title":"Patient Training Initiatives on Drug Development and Future Challenges：Developing a Social Infrastructure for Patient Engagement in Drug Development","authors":"Yuta Kasai, Kenma Nozaki, Nobutaka Yagi, Shintaro Omuro, Keiko Omomo, Kotone Matsuyama","doi":"10.3999/jscpt.54.4_173","DOIUrl":"https://doi.org/10.3999/jscpt.54.4_173","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45121497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Development of a Concept Sheet for Pediatric Clinical Trials 儿科临床试验概念表的开发
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS Pub Date : 2023-07-31 DOI: 10.3999/jscpt.54.4_167
Kayoko Kikuchi, M. Sako, Hidefumi Nakamura
{"title":"Development of a Concept Sheet for Pediatric Clinical Trials","authors":"Kayoko Kikuchi, M. Sako, Hidefumi Nakamura","doi":"10.3999/jscpt.54.4_167","DOIUrl":"https://doi.org/10.3999/jscpt.54.4_167","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45163206","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
2021年度日本臨床薬理学会海外研修員報告： 研修完了報告書 2021年度日本临床薬理学会海外研修员报告：研修完了报告书
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS Pub Date : 2023-07-31 DOI: 10.3999/jscpt.54.4_181
Hirokazu Wakuda
{"title":"2021年度日本臨床薬理学会海外研修員報告： 研修完了報告書","authors":"Hirokazu Wakuda","doi":"10.3999/jscpt.54.4_181","DOIUrl":"https://doi.org/10.3999/jscpt.54.4_181","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46685764","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
2. Side Effects and Care of Molecular Targeted Drugs 2. 分子靶向药物的副作用及护理
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS Pub Date : 2023-05-31 DOI: 10.3999/jscpt.54.3_123
Satomi YAMADA
{"title":"2. Side Effects and Care of Molecular Targeted Drugs","authors":"Satomi YAMADA","doi":"10.3999/jscpt.54.3_123","DOIUrl":"https://doi.org/10.3999/jscpt.54.3_123","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":"54 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135434235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
4 ．骨転移患者を診るポイント 4.诊断骨转移患者的要点
JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS Pub Date : 2023-05-31 DOI: 10.3999/jscpt.54.3_135
Makoto Endo
{"title":"4 ．骨転移患者を診るポイント","authors":"Makoto Endo","doi":"10.3999/jscpt.54.3_135","DOIUrl":"https://doi.org/10.3999/jscpt.54.3_135","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47803044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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