Rinsho Yakuri\/japanese Journal of Clinical Pharmacology and Therapeutics最新文献

{"title":"Proposal of Quality Management in Clinical Trials based on the Concept of ICH Guideline Q8","authors":"F. Kojima, Toko Shimomukai, M. Yoshihara, Hiroaki Shakudo, K. Kariya, Toru Hirai","doi":"10.3999/JSCPT.49.15","DOIUrl":"https://doi.org/10.3999/JSCPT.49.15","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"13 10","pages":"15-21"},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91499070","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":"Pharmacokinetics of Loxoprofen and Cefcapene following a Single Combined Dose in Healthy Volunteers before, during or Immediately after 120-min Enteral Tube Feeding of 400 mL Ensure Liquid®","authors":"Mikiko Ueda, Kazuo Harada, K. Ikeda, Minako Ohishi, M. Kitamura, H. Ueda, Katsumi Azenishi, Setsu Inatsuki, Kazunori Niki, C. Okajima, Mamoru Tempaku, Y. Fukuda, S. Yoshida, K. Hirata, Shinichiro Suna, K. Kataoka, M. Kogo, E. Uejima","doi":"10.3999/JSCPT.48.185","DOIUrl":"https://doi.org/10.3999/JSCPT.48.185","url":null,"abstract":"Many patients in medical and nursing care facilities cannot ingest food orally. The reasons for the difficulty in ingesting food vary and may include decreased swallowing function, decreased cognitive function, and decreased gastrointestinal tract function, which may be ageor disease-related or associated with surgical management. In such patients, the enteral tube feeding method is commonly used for nutritional management, and oral drugs are often administered through a nasogastric tube for enteral tube feeding. Generally, tablets and capsules are administered either in the pulverized form or through a simple suspension method. The Osaka University Dental Hospital(the hospital at which this study took place)manages patients with diseases affecting the oral cavity in particular. Approximately 40% of the inpatients receive nutrition through an enteral tube feeding over the treatment period or as treatment progresses after surgery. In particular, antibiotics and analgesics are administered as part of the surgical management. The administration of many pharmaceutical products, with or without regard to food, is usually documented in package inserts. The pharmacokinetics of investigational drugs are to be investigated in clinical pharmacology studies, with concomitant ingestion of regular food as a prerequisite. However, the pharmacokinetics of drugs administered in patients receiving enteral tube feeding have not been investigated thus far for many drugs. Therefore, this study investigated the pharmacokinetic profiles of drugs commonly used for surgical management when a pharmaceutical product is administered before, during, and after tube feeding(meals)under enteral tube feeding management, using loxoprofen and cefcapene pivoxil hydrochloride fine granules as the test drugs. Loxoprofen is a representative nonsteroidal anti-inflammatory 臨床薬理 Jpn J Clin Pharmacol Ther 2017; 48(6): 185-193 185","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"39 1","pages":"185-193"},"PeriodicalIF":0.0,"publicationDate":"2017-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85182855","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 1st Annual Meeting of the Hokkaido & Tohoku Regions of the JSCPT","authors":"Norihiro Sato","doi":"10.3999/JSCPT.48.213","DOIUrl":"https://doi.org/10.3999/JSCPT.48.213","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"10 1","pages":"213-216"},"PeriodicalIF":0.0,"publicationDate":"2017-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78281065","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":"ゲノム・遺伝子解析が付随した治験の倫理審査における課題 ―セントラルIRBの審査体制確立のために―","authors":"Akiko Okumura, Yoichi Yamamoto","doi":"10.3999/JSCPT.48.195","DOIUrl":"https://doi.org/10.3999/JSCPT.48.195","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"6 1","pages":"195-203"},"PeriodicalIF":0.0,"publicationDate":"2017-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78620225","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":"Influences of Long-Term, High-Dose Acetaminophen Administration on Liver Function Markers in Healthy Japanese Adults","authors":"Ildae Song, R. Tanaka, Masako Aso, Yasutoshi Sakamoto, M. Maeda, Michiru Ochiai, Yoshiro Saito, K. Maekawa, Y. Kumagai","doi":"10.3999/JSCPT.48.153","DOIUrl":"https://doi.org/10.3999/JSCPT.48.153","url":null,"abstract":"Background : Acetaminophen is widely used as an analgesic and antipyretic; however, acetaminophen overdose is known to cause hepatic injury. However, minor and self-limiting alanine aminotransferase ( ALT ) elevation unrelated to hepatic injury is occasionally observed in individuals receiving high-dose acetaminophen. The aim of this study was to evaluate the changes in liver function markers induced by long-term, high-dose acetaminophen administration. Methods : Acetaminophen ( 3000 mg ／ day ) or placebo was re-peatedly administered to 242 healthy Japanese adults for 28 days. Plasma samples collected on Day 1 were used to measure the pharmacokinetics of acetaminophen. Liver function was monitored in terms of aspartate aminotransferase ( AST ) , ALT, alkaline phosphatase ( ALP ) , total bilirubin ( T-Bil ) , and high mobility group box 1 ( HMGB-1 ) levels for 35 days, from the day of the first dose. Subjects were withdrawn from the study if their AST, ALT, or ALP levels exceeded twice the respective upper limit of normal ( 2 × ULN ) . Results : From a total of 242 subjects, 202 and 40 subjects were assigned to the acetaminophen group and the placebo group, respectively. Twelve subjects in the acetaminophen group ( 6 . 0 ％) were withdrawn owing to ALT elevation over 2 × ULN; no subjects were withdrawn from the placebo group. During the study period, ALT was higher in the acetaminophen group than in the placebo group, and increased from Day 7 to 14 after the start of administration. However, no evidence of hepatic injury owing to acetaminophen was observed, and the ALT elevation was attenuated after Day 14. Moreover, no correlation was observed between maximum ALT and levels of HMGB-1, a novel biomarker candidate for hepatic injury, during the study period. These findings led us to conclude that the ALT elevation was not caused by hepatic injury. Conclusion : ALT elevation ＞ 2 × ULN was observed in 6 . 0 ％ of subjects in the acetaminophen group. However, no subjects developed hepatic injury, and ALT levels started to return to the normal values even during continued administration. The phenomenon of adaptation may be involved in these changes. -","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"86 1","pages":"153-159"},"PeriodicalIF":0.0,"publicationDate":"2017-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83765419","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 2nd Annual Meeting of the Tokai & Hokuriku Regions of the JSCPT","authors":"M. Nishikawa","doi":"10.3999/JSCPT.48.177","DOIUrl":"https://doi.org/10.3999/JSCPT.48.177","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"67 1","pages":"177-180"},"PeriodicalIF":0.0,"publicationDate":"2017-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73204931","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":"Partial Pill Counts for Assessments of Medication Adherence in Type 2 Diabetic Patients Treated with Polypharmacy","authors":"M. Takahara, T. Shiraiwa, Naoko Ogawa, Mayumi Yamamoto, Kaoru Yamamoto, Masayuki Doi, Y. Yoshida, Setsuko Gotou","doi":"10.3999/JSCPT.48.173","DOIUrl":"https://doi.org/10.3999/JSCPT.48.173","url":null,"abstract":"Jpn J Clin Pharmacol Ther . 2017; 48 ( 5 ) : 173 - 175 Abstract Background : Although pill counts can objectively measure medication adherence, they are often labor-intensive and time-consuming, especially in patients taking numerous medications. We hypothesized that counting pills for not all but only some medications, which would undoubtedly spare time and labor, could provide reliable information on adherence to all medications. The aim of the present study was to evaluate how accurately medication adherence could be assessed using partial pill counts. Methods : We retrospectively analyzed pill count data from 158 consecutive Japanese type 2 diabetic outpatients treated with polypharmacy. Adherence was defined as an 80 ％ or higher medication consumption rate, whereas non-adherence was defined as ＜ 80 ％ . We assessed how accurately a patient ʼ s adherence to one medication could be predicted based on information on his ／ her adherence to another medication. Results : The positive likelihood ratio for adherence ( i.e., reciprocal of the negative likelihood ratio of non-adherence ) was 2 . 4 ( 95 ％ confidence interval: 1 . 7 to 3 . 3 ) , whereas that for non-adherence ( i.e., reciprocal of the negative likelihood ratio of adherence ) was 9 . 9 ( 95 ％ confidence interval: 7 . 1 to 13 . 8 ) ( both p ＜ 0 . 05 ) . The accuracy was dependent on the consistency of administration times. Adherence ( or non-adherence ) to a medication could be more accurately predicted based on information regarding another medication with the same administration schedule, compared with another with a different administration schedule. Conclusion : Adherence ( or non-adherence ) to medications could be predicted with considerable accuracy based on information regarding adherence ( or non-adherence ) to another medication in type 2 diabetic patients treated with polypharmacy.","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"23 1","pages":"173-175"},"PeriodicalIF":0.0,"publicationDate":"2017-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80186550","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":"A Single-Center Experience with Japanese Patients with Severe Ischemic Heart Failure and Arrhythmia Receiving Amiodarone","authors":"A. Suzuki, T. Shiga, Kotaro Arai, N. Hagiwara","doi":"10.3999/JSCPT.48.161","DOIUrl":"https://doi.org/10.3999/JSCPT.48.161","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"44 1","pages":"161-165"},"PeriodicalIF":0.0,"publicationDate":"2017-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74429120","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":"Completion Report of the Overseas Training Program Awarded by Japanese Society of Clinical Pharmacology and Therapeutics in 2015","authors":"R. Kato","doi":"10.3999/JSCPT.48.149","DOIUrl":"https://doi.org/10.3999/JSCPT.48.149","url":null,"abstract":"","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"6 1","pages":"149-151"},"PeriodicalIF":0.0,"publicationDate":"2017-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80262935","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":"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Galcanezumab, a Monoclonal Antibody to Calcitonin Gene-Related Peptide, in Healthy Japanese and Caucasian Subjects","authors":"M. Nakano, K. Uenaka, W. Kielbasa, Y. Matsuyama, Akichika Ozeki, M. Ayan-Oshodi","doi":"10.3999/JSCPT.48.131","DOIUrl":"https://doi.org/10.3999/JSCPT.48.131","url":null,"abstract":"s : American Headache Society® 58th Annual Scientific Meeting. Headache. 2016; 56(Suppl 1) : PS29. doi : 10.1111/head. 12832. 17) Bourdage JS, Cook CA, Farrington DL, Chain JS, Konrad RJ. An Affinity Capture Elution (ACE) assay for detection of anti-drug antibody to monoclonal antibody therapeutics in the presence of high levels of drug. J Immunol Methods. 2007; 327 (1-2) : 10-17. doi : 10.1016/j.jim.2007.07.004. 18) de Hoon J, Monteith D, Vermeersch S, Van Hecken A, Abu-Raddad E, Collins E, et al. Safety, pharmacokinetics, and pharmacodynamics of LY2951742: a monoclonal antibody targeting CGRP. In : International Headache Congress 2013 Program of Abstracts. Cephalalgia. 2013; 33 (Suppl 8) : P367. doi : 10.1177/0333102413490487. 19) Miller B, Collins EC, Hodsdon M, Camporeale A, Nguyen H, Oakes T, et al. Evaluation of treatment-emergent anti-drug antibodies following administration of LY2951742, a calcitonin gene-related peptide antibody, to migraine patients. In : Program Abstracts : American Headache Society®58th Annual Scientific Meeting. Headache. 2016; 56(Suppl 1) : PS43. doi : 10.1111/head.12832. 20) Davda JP, Hansen RJ. Properties of a general PK/PD model of antibody-ligand interactions for therapeutic antibodies that bind to soluble endogenous targets. MAbs. 2010; 2 (5) : 576-88. doi : 10.4161/mabs.2.5.12833. NAKANO, et al. : Safety and PK of Galcanezumab in Japanese Subjects 139","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"77 1","pages":"131-139"},"PeriodicalIF":0.0,"publicationDate":"2017-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76898641","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}