巻号一覧
46 巻 (2015)
- 6 号 p. 253-
- 5 号 p. 225-
- 4 号 p. 179-
- 3 号 p. 115-
- 2 号 p. 55-
- 1 号 p. 3-
46 巻, 2 号
選択された号の論文の10件中1～10を表示しています
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原著
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小林 江梨子, 浅田 和広, 阿部 智美, 荒田 尚子, 大山 邦男, 川上 明三, 工藤 賢三, 小村 誠, 島田 安博, 鳥山 五月, ...2015 年 46 巻 2 号 p. 55-63
発行日: 2015/03/31
公開日: 2015/04/15
ジャーナル 認証ありPrescription drug labeling currently used in clinical practice is legally required drug information, and is regulated by the MHLW notification entitled “Guidance to describe prescription drug labeling” issued in 1997. Previous research has revealed that the majority of physicians and pharmacists, who are real users of the drug labeling, acknowledged the importance of drug labeling and recognized that the order of description in the labeling is appropriate. However, over a half of them did not recognize that “conditions for approval” are described in the labeling. The aim of the present study was to develop new format and contents of prescription drug labeling and to verify the new labeling by a large-scale questionnaire survey on physicians and pharmacists who work in clinical practice. New format and contents of prescription drug labeling were created to solve the problems indicated by previous studies. The questionnaire was distributed by post to 2,004 physicians and pharmacists to verify the new format and contents of prescription drug labeling, and 1,100 questionnaires were returned (response rate: 54.9%). Over 85% of respondents agreed to number all the items in drug labeling. Over 84% of them agreed to group the information of patients included in “administration with caution”, “pediatrics”, “pregnant and lactating women” and “elderly” into a single item of “information on special populations”. Regarding the newly created item “information on medical insurance coverage”, the majority of the respondents (over 96%) agreed. The proposed new format and contents of prescription drug labeling were verified and supported by physicians and pharmacists. Further activities are needed to distribute the proposed new format and contents of prescription drug labeling to a wide range of medical professionals to collect more opinions.抄録全体を表示PDF形式でダウンロード (4455K) -
佐藤 彰秀, 成川 衛2015 年 46 巻 2 号 p. 65-70
発行日: 2015/03/31
公開日: 2015/04/15
ジャーナル 認証ありWe conducted a retrospective study to review the no-observed-adverse-effect levels (NOAEL) in nonclinical studies and the first-human-doses (FHD) in first-in-human (FIH) studies, and to investigate the safety factors used in past FIH studies. In addition, we examined several potential factors that may influence the dose setting. Ethical drugs containing a new chemical entity approved in Japan from 2008 to 2012 were included in the present study. A human-equivalent dose of NOAEL (NHD) was calculated from NOAEL obtained from toxicity studies, based on the body surface area. The ratio of NHD to FHD was defined as the “FHD index” in this study, which was a synonym of safety factor based on body surface area. Drugs in the following categories were excluded from the study: biopharmaceuticals, derivatives of existing drug (including prodrug, active metabolite, and optical isomer), historically established medicines, combination drugs, topical application drugs, and general anaesthesia and relative medicines. In many therapeutic areas other than oncology, the safety factor to determine the starting dose in FIH studies was greater than 10, which was recommended by FDA guidance document. This finding suggested that the starting doses had been determined very prudently in past FIH studies. No apparent differences in FHD index were observed with respect to administration route (oral versus injection), subject population in FIH study (Japanese versus non-Japanese), and the most sensitive species in toxicity studies. No apparent relationship between the FHD index and the quantity of species-difference in NOAEL was identified in this study.抄録全体を表示PDF形式でダウンロード (1180K) -
飯村 美波, 土岐 浩介, 嶋田 沙織, 鶴嶋 英夫, 松村 明, 本間 真人2015 年 46 巻 2 号 p. 71-75
発行日: 2015/03/31
公開日: 2015/04/15
ジャーナル 認証ありClinical trial sponsors have been requested to improve the on-site visit activities of clinical research associates (CRA) in Japan, because their activities are less efficient compared with those in the European Union and the United States. Although the sponsors have taken various measures in attempts to improve on-site visit activities, it is unknown whether or not the measures are effective to improve current activities at trial sites in Japan. We therefore surveyed the on-site visit activities of CRA at the University of Tsukuba Hospital. The mean number of on-site visits made by CRA decreased from 14.4 to 10.0/year per clinical trial from 2006 to 2012. The change in number of on-site visits differed depending on the objective of visit: the number of visits for transfer of documents and meetings for explanation of clinical trial information tended to decrease, while the number of visits for source data verification (SDV) as well as delivery and return of investigational products tended to increase. Outsourcing the delivery of investigational products to general transportation companies was started from 2009 (constituting 44% of all deliveries in 2012), and the frequencies of delivery and return of investigational products had increased using interactive voice response system or interactive web response system. These findings suggest that improvement in SDV as well as delivery and return of investigational products may have improved the on-site visit activities of CRA.抄録全体を表示PDF形式でダウンロード (1099K)
症例報告
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Terumi ITOH, Ainari KONDA, Sachiko YASUDA, Takuya FUJIMURA, Mayuko ...2015 年 46 巻 2 号 p. 77-79
発行日: 2015/03/31
公開日: 2015/04/15
ジャーナル 認証ありA 26-year-old man treated for epilepsy with sodium valproate (VPA-Na, 800 mg/day) was admitted to the emergency room with dehydration, poor appetite, fatigue, arthralgia and general malaise. He stated that he had taken 50 VPA-Na tablets at 12:00 midnight because he was hungry. Clinical findings on admission included blood pressure, 106/60 mmHg; body temperature, 36.9℃; percutaneous oxygen saturation, 98%; plasma total protein, 5.9 g/dL; and plasma ammonia level, 291 μg/dL. Markers of hepatic and renal functions and amylase levels were all within normal ranges. Serum total and free VPA concentrations at 16 h after VPA-Na ingestion were respectively 218 and 98 μg/mL, decreasing to 122 and 31 μg/mL at 31 h, and 66 and 11 μg/mL at 55 h after ingestion. Plasma ammonia level correlated linearly with both serum total and unbound VPA concentrations, but the correlation coefficient (r) for the latter (0.980) tended to be greater than that for the former (0.998). These results suggest that serum unbound VPA concentration may be a better biomarker for predicting the time course of hyperammonemia in patients with VPA intoxication.抄録全体を表示PDF形式でダウンロード (993K)
第21回 臨床薬理学講習会記録（2014年度) 「特殊病態における臨床薬理学」
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志賀 剛2015 年 46 巻 2 号 p. 83-88
発行日: 2015/03/31
公開日: 2015/04/15
ジャーナル 認証ありPDF形式でダウンロード (1264K) -
越前 宏俊2015 年 46 巻 2 号 p. 89-92
発行日: 2015/03/31
公開日: 2015/04/15
ジャーナル 認証ありPDF形式でダウンロード (1148K) -
鶴岡 秀一2015 年 46 巻 2 号 p. 93-98
発行日: 2015/03/31
公開日: 2015/04/15
ジャーナル 認証ありPDF形式でダウンロード (1447K) -
長谷川 純一2015 年 46 巻 2 号 p. 99-103
発行日: 2015/03/31
公開日: 2015/04/15
ジャーナル 認証ありPDF形式でダウンロード (1045K) -
中村 秀文2015 年 46 巻 2 号 p. 105-111
発行日: 2015/03/31
公開日: 2015/04/15
ジャーナル 認証ありPDF形式でダウンロード (4906K) -
村島 温子2015 年 46 巻 2 号 p. 112-114
発行日: 2015/03/31
公開日: 2015/04/15
ジャーナル 認証ありPDF形式でダウンロード (1086K)
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