{"title":"Risk-based Approach to Determine the Need for an Audit: In What Situations Should an Audit Be Performed? （Japanese Translation Version）","authors":"Kouji Nakamura, Akiko M. Saito, Kohei Ueda, Kunihiro Ueda, Kumiko Yoshihara, Nobuyoshi Hiramatsu, Yoshie Yamashita, Yuki Kusaka, Hideaki Ui","doi":"10.3999/jscpt.54.1_37","DOIUrl":"https://doi.org/10.3999/jscpt.54.1_37","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48855750","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}
{"title":"Study on Relationship Visualization of Clinical Research-related Laws Using Word-matching","authors":"Ayako Ohshiro, T. Okazaki, S. Ueda","doi":"10.3999/jscpt.54.1_43","DOIUrl":"https://doi.org/10.3999/jscpt.54.1_43","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47766671","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}
{"title":"Paid-for Transfer of Human Samples in Research Biobanks and the Applicability of Charitable Trusts","authors":"W. Toya, Keiichiro Yamamoto, K. Aizawa, K. Matsui","doi":"10.3999/jscpt.54.1_29","DOIUrl":"https://doi.org/10.3999/jscpt.54.1_29","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70396013","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}
Ferrara M, Trevisan G, M. l., Accardo G, Fantino S, A. F., Drappero E, Tettoni M, De Vivo E, I. A., D. A, D. A., Calcagno A, B. S
Background: Doravirine (DOR) and Rilpivirine (RPV) are the NNRTIs currently most used in the clinical setting, in dual and triple drug regimens (2DR and 3DR). Intracellular (IC) Pharmacokinetics (PK) of these drugs has not been fully elucidated. Our aim was to compare plasma PK and IC accumulation in real-life experienced patients (pts). Methods: Pts on DOR- and RPV-including Antiretroviral (ARV) regimen were considered. DOR and RPV plasma and IC (PBMCs) concentrations were measured at 12 (37%) (T12) and 24 ± 4 hours (63%) (T24) after last drug intake by means of UHPLC-MSMS validated methods. Results: 90 pts (65% on 3DR and 35% on 2DR) were included: 52% on DOR- and 48% on RPV-containing ARV. RPV IC/plasma ratio was significantly higher than DOR IC/plasma ratio: 6.034 (4.878-7.186) vs. 1.479 (1.256-1.702) (p=0.001) independently from timing T12 (p=0.003) and T24 (p<0.001). RPV in 3DR resulted to have higher plasma and IC accumulation compared to 2DR. Linear and significative correlations between DOR and RPV plasma and IC concentrations were found (+0.749, p<0.001 and +0.733, p<0.001). No significative correlation between overall DOR and RPV PK and creatinine, BMI or age or difference by gender was found. Conclusion: RPV proved to accumulate in PBMCs at a higher degree as compared to DOR: RPV and DOR IC levels were 498% and 50% higher than in plasma. RPV showed an IC PBMC/plasma ratio 3-fold higher than DOR. Potential explanation could rely on the higher lipophilicity of RPV. Clinical significance of these data needs to be investigated in further studies.
{"title":"Doravirine and Rilpivirine Intra Cellular Accumulation in the Clinical Setting","authors":"Ferrara M, Trevisan G, M. l., Accardo G, Fantino S, A. F., Drappero E, Tettoni M, De Vivo E, I. A., D. A, D. A., Calcagno A, B. S","doi":"10.33597/jcpt-03-id1035","DOIUrl":"https://doi.org/10.33597/jcpt-03-id1035","url":null,"abstract":"Background: Doravirine (DOR) and Rilpivirine (RPV) are the NNRTIs currently most used in the clinical setting, in dual and triple drug regimens (2DR and 3DR). Intracellular (IC) Pharmacokinetics (PK) of these drugs has not been fully elucidated. Our aim was to compare plasma PK and IC accumulation in real-life experienced patients (pts). Methods: Pts on DOR- and RPV-including Antiretroviral (ARV) regimen were considered. DOR and RPV plasma and IC (PBMCs) concentrations were measured at 12 (37%) (T12) and 24 ± 4 hours (63%) (T24) after last drug intake by means of UHPLC-MSMS validated methods. Results: 90 pts (65% on 3DR and 35% on 2DR) were included: 52% on DOR- and 48% on RPV-containing ARV. RPV IC/plasma ratio was significantly higher than DOR IC/plasma ratio: 6.034 (4.878-7.186) vs. 1.479 (1.256-1.702) (p=0.001) independently from timing T12 (p=0.003) and T24 (p<0.001). RPV in 3DR resulted to have higher plasma and IC accumulation compared to 2DR. Linear and significative correlations between DOR and RPV plasma and IC concentrations were found (+0.749, p<0.001 and +0.733, p<0.001). No significative correlation between overall DOR and RPV PK and creatinine, BMI or age or difference by gender was found. Conclusion: RPV proved to accumulate in PBMCs at a higher degree as compared to DOR: RPV and DOR IC levels were 498% and 50% higher than in plasma. RPV showed an IC PBMC/plasma ratio 3-fold higher than DOR. Potential explanation could rely on the higher lipophilicity of RPV. Clinical significance of these data needs to be investigated in further studies.","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":"18 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73885391","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}
{"title":"Report of the 6th Annual Meeting of the Kanto & Koushinetsu Region of the JSCPT","authors":"T. Fujita","doi":"10.3999/jscpt.53.6_263","DOIUrl":"https://doi.org/10.3999/jscpt.53.6_263","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45318750","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}
{"title":"Report of the 6th Annual Meeting of the Kinki Region of the JSCPT","authors":"Yoji Nagai","doi":"10.3999/jscpt.53.6_273","DOIUrl":"https://doi.org/10.3999/jscpt.53.6_273","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42274180","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}
{"title":"National Survey on Clinical Practice of Gene Therapy using Adeno-associated Virus Vector ―The Actual Status and Hurdle on Clinical Practice in Gene Therapy for Spinal Muscular Atrophy―","authors":"Masayoshi Nakakuni, M. Onodera","doi":"10.3999/jscpt.53.6_217","DOIUrl":"https://doi.org/10.3999/jscpt.53.6_217","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43800817","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}
Yutaka Takahashi, Mirai Kawano, Hidefumi Kobayashi, Hiromitsu Takahashi, R. Koike
{"title":"An Approach for Packaging to Prevent Mix-up of Investigational Drugs","authors":"Yutaka Takahashi, Mirai Kawano, Hidefumi Kobayashi, Hiromitsu Takahashi, R. Koike","doi":"10.3999/jscpt.53.6_243","DOIUrl":"https://doi.org/10.3999/jscpt.53.6_243","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48885597","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}
{"title":"Mechanisms of GLP‒1 Receptor Agonists on the Cardio-Renal Protective Effects","authors":"S. Kuriyama, Kei Matsumoto","doi":"10.3999/jscpt.53.6_249","DOIUrl":"https://doi.org/10.3999/jscpt.53.6_249","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42307743","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}
Motoki Arakawa, M. Wakita, Ayumi Sahashi, Junichi Nishino, Kiyotaka Nakajima, S. Hidaka
{"title":"Nutrient Profiling for Salt Content on Simplified Front-of-package Labels for Japanese Patients with Hypertension","authors":"Motoki Arakawa, M. Wakita, Ayumi Sahashi, Junichi Nishino, Kiyotaka Nakajima, S. Hidaka","doi":"10.3999/jscpt.53.6_207","DOIUrl":"https://doi.org/10.3999/jscpt.53.6_207","url":null,"abstract":"","PeriodicalId":14602,"journal":{"name":"JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42393194","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}
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