文献一覧: 03881601 (ISSN) - Ceek.jp Altmetrics

1 0 0 0 OA 6.医薬品の臨床試験と承認審査におけるPK-PDの活用

著者: 佐藤玲子
出版者: 一般社団法人日本臨床薬理学会
雑誌: 臨床薬理 (ISSN:03881601)
巻号頁・発行日: vol.41, no.4, pp.181-184, 2010 (Released:2010-10-08)
参考文献数: 4

2020-07-16 10:09:44
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1 0 0 0 OA 医薬品の臨床開発におけるアダプティブ・デザイン ―米国研究製薬工業協会ワーキング・グループのエグゼクティブ・サマリー邦訳―

著者: 小宮山靖越水孝菅波秀規酒井弘憲渡橋靖東宮秀夫
出版者: 一般社団法人日本臨床薬理学会
雑誌: 臨床薬理 (ISSN:03881601)
巻号頁・発行日: vol.40, no.6, pp.303-310, 2009 (Released:2009-12-25)
参考文献数: 22

A PhRMA Working Group on adaptive clinical trial designs has been formed to investigate and facilitate opportunities for wider acceptance and usage of adaptive designs and related methodologies. A White Paper summarizing the findings of the group is currently in preparation. This article is an Executive Summary of that full White Paper; it summarizes the findings and recommendations of the group. Logistic, operational, procedural, and statistical challenges associated with adaptive designs are addressed. Three particular areas where adaptive designs can likely be utilized beneficially are discussed: dose finding, seamless Phase II/III trial designs, and sample size reestimation.

2020-04-08 20:52:01
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1 0 0 0 製薬企業の見方 : ヒト化抗HER2モノクローナル抗体(ハーセプチン^【○!R】)の開発を例に

著者: 仁平新一
出版者: 一般社団法人日本臨床薬理学会
雑誌: 臨床薬理 = JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS (ISSN:03881601)
巻号頁・発行日: vol.35, no.2, pp.363S-364S, 2004-03-31
参考文献数: 2

2020-04-03 11:59:09
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1 0 0 0 OA 健康成人における抗ヒスタミン薬の中枢抑制作用に関する研究

著者: 脇坂真美宋一大田ヶ谷浩邦藤田朋恵前田実花野村今日子小林真美山本明子坂本泰理田中理英子熊谷雄治
出版者: 一般社団法人日本臨床薬理学会
雑誌: 臨床薬理 (ISSN:03881601)
巻号頁・発行日: vol.46, no.5, pp.243-248, 2015-09-30 (Released:2016-01-15)
参考文献数: 15

The aim of the present trial was to compare the sedative effects of second generation antihistamines in healthy adult male volunteers. This randomized, double-blind, cross-over clinical trial compared the effects of single doses of olopatadine 5 mg, ketotifen fumarate 1.38 mg, fexofenadine 60 mg, and placebo on psychomotor function in 15 healthy male subjects who gave written informed consent for participation in the study. For each sedative, sleep latency time was measured using the multiple sleep latency test (MSLT); and psychomotor function was measured by thresholds of critical flicker fusion (CFF), the digit symbol substitution test (DSST), and a Straight line Analog Rating Scale (LARS). Measurements were performed before and 2, 5, and 8h after drug administration. The differences between the drugs and placebo were analyzed by repeated analysis of variance (ANOVA) and paired t-tests as appropriate. Intergroup differences in baseline values of all parameters were not significant. Ketotifen induced the shortest sleep latency at 2h (p=0.03 vs. fexofenadine, p=0.03 vs. olopatadine) and 5h (p=0.04 vs. fexofenadine) after administration. Ketotifen also showed the most prolonged recognition (CFF down) at 2h (p<0.001 vs. fexofenadine, p=0.03 vs. olopatadine) and 8h (p=0.01 vs. fexofenadine). Olopatadine showed a more prolonged recognition than fexofenadine at 2h (p=0.03). Ketotifen induced the greatest decline in concentration and cognitive function at 8h (p=0.03) according to DSST. The drugs affected objective psychomotor function without causing subjective symptoms as shown by no significant differences in LARS score. The study indicates that the extent of impaired performance, an important adverse drug reaction, may differ even among second generation antihistamines.

2020-03-16 02:03:34
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1 0 0 0 OA アニラセタム (サープル, ドラガノン) の効能・効果は証明されていない

著者: 橋本健太郎林敬次柳元和梅田忠斎浜六郎
出版者: 一般社団法人日本臨床薬理学会
雑誌: 臨床薬理 (ISSN:03881601)
巻号頁・発行日: vol.30, no.1, pp.199-200, 1999-01-31 (Released:2010-06-28)
参考文献数: 4

2020-03-10 16:04:53
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1 0 0 0 OA 2.過活動膀胱の病態と薬物治療

著者: 吉田正貴永田卓士桝永浩一宮本豊工藤惇三
出版者: 一般社団法人日本臨床薬理学会
雑誌: 臨床薬理 (ISSN:03881601)
巻号頁・発行日: vol.40, no.5, pp.201-206, 2009 (Released:2009-11-25)
参考文献数: 17
被引用文献数: 1

Overactive bladder (OAB) syndrome, which is characterized by a complex of storage symptoms (urinary urgency, frequency, nocturia and urgency incontinence) is highly prevalent in the general population; it causes significant distress to patients in terms of their psychosocial and physical functioning. Muscarinic receptors of bladder smooth muscles are involved in both normal and involuntary detrusor contraction (detrusor overactivity). Up-regulation of the muscarinic receptor function may contribute to the pathophysiology of OAB. In addition, several reports have suggested that various stimulations release many substances (ATP, prostaglandins, nitric oxide and acetylcholine) from bladder urothelium, which contribute to the pathophysiology of the increased bladder sensation, OAB symptoms and detrusor overactivity. The bladder urothelium also prossesses the non-neuronal cholinergic system and high density of muscarinic receptors. The roles and functions of the non-neuronal cholinergic system in OAB are currently under evaluation. Furthermore, new action sites of anticholinergic drugs have also been proposed. In this review, in addition to the pathophysiology of detrusor overactivity and OAB, the pharmacotherapy for OAB is discussed.

2020-01-17 18:38:06
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1 0 0 0 OA 日本における依存性薬物乱用の動向

著者: 加藤正明
出版者: 一般社団法人日本臨床薬理学会
雑誌: 臨床薬理 (ISSN:03881601)
巻号頁・発行日: vol.5, no.2, pp.100-103, 1974-06-30 (Released:2010-06-28)

2020-01-02 15:43:40
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1 0 0 0 OA 2.MEGA研究

著者: 渡邉裕司
出版者: 一般社団法人日本臨床薬理学会
雑誌: 臨床薬理 (ISSN:03881601)
巻号頁・発行日: vol.39, no.5, pp.147-150, 2008 (Released:2009-02-05)
参考文献数: 9

2019-12-07 15:08:55
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1 0 0 0 OA 生物学的同等性試験における検出力

著者: 鈴木徳治藤田正一古座谷醇大木俊光
出版者: The Japanese Society of Clinical Pharmacology and Therapeutics
雑誌: 臨床薬理 (ISSN:03881601)
巻号頁・発行日: vol.14, no.3, pp.437-452, 1983-09-30 (Released:2010-06-28)
参考文献数: 39

The usefulness of an approximation formula to calculate the power of analysis of variance for bioequivalence tests in a two-way crossover design was examined by comparison with the power estimated from the upper probability integrals of the noncentral F-distribution. The approximation formula was shown to be useful for the calculation of the power for usual bioequivalence tests . The calculation of the power for bioequivalence tests in a multi-way crossover design was attempted using the approximation formula.Further, data in previously published reports on bioequivalence between drug preparations were reviewed from the standpoint of the power. Only 24 of 86 bioequivalence analyses conducted with 25 different drugs gave a power higher than 80% to detect a 20% difference in bioavailability with α=0.05, and the power of about a half of the analyses was lower than 50%.

2019-11-19 23:03:03
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1 0 0 0 OA 透析患者の皮膚そう痒症に対する止痒外用剤の検討

著者: 田近奈津子上野雄一郎木下保子榊原千賀大桃美穂羽生訓子山本裕美子宇田川崇山本亮木村弘章
出版者: 一般社団法人日本臨床薬理学会
雑誌: 臨床薬理 (ISSN:03881601)
巻号頁・発行日: vol.35, no.1, pp.176S, 2004-01-31 (Released:2010-06-28)
参考文献数: 3

2019-07-13 02:43:20
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1 0 0 0 5 .臨床薬理学視点からみる最近の医薬品臨床試験の落とし穴誰のための臨床試験?

著者: 植田真一郎
出版者: 一般社団法人日本臨床薬理学会
雑誌: 臨床薬理 (ISSN:03881601)
巻号頁・発行日: vol.50, no.3, pp.125-129, 2019

2019-07-10 02:05:06
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1 0 0 0 3 .姿勢としての研究倫理のススメ

著者: 金城隆展
出版者: 一般社団法人日本臨床薬理学会
雑誌: 臨床薬理 (ISSN:03881601)
巻号頁・発行日: vol.50, no.3, pp.112-114, 2019

2019-07-10 02:05:05
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1 0 0 0 OA 5.横紋筋融解症の診断基準設定に関する提案

著者: 原田和博
出版者: 一般社団法人日本臨床薬理学会
雑誌: 臨床薬理 (ISSN:03881601)
巻号頁・発行日: vol.39, no.3, pp.35S-36S, 2008 (Released:2009-02-04)
参考文献数: 3

2019-06-20 12:30:33
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1 0 0 0 OA ヒトCYPIA2の遺伝子多型と人種差に関する研究

著者: 中村克徳横井毅中島美紀 Fred F. Kadlubar 鎌滝哲也
出版者: 一般社団法人日本臨床薬理学会
雑誌: 臨床薬理 (ISSN:03881601)
巻号頁・発行日: vol.26, no.1, pp.243-244, 1995-03-31 (Released:2010-06-28)
参考文献数: 6

2019-06-03 10:44:24
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1 0 0 0 OA 肺癌患者における塩酸イリノテカン (CPT-11) の胸水中および心嚢液中への移行性

著者: 井藤達也高岡和夫竹本功秦温信井上勝一佐々木健太郎平野剛井関健菅原満宮崎勝巳
出版者: The Japanese Society of Clinical Pharmacology and Therapeutics
雑誌: 臨床薬理 (ISSN:03881601)
巻号頁・発行日: vol.33, no.2, pp.47-52, 2002-03-31 (Released:2010-06-28)
参考文献数: 13

The purpose of this study was to evaluate the distribution of CPT-11 and its active metabolite, SN-38, in pleural and pericardial fluid after intravenous administration.Two patients with lung cancer were treated with intravenous CPT-11 (60 mg/m2) on days 1, 8, and 15. The CPT-11 was detected in the pleural fluid 1.5 hr after the begining of intravenous infusion, and the level reached the maximum 24 hrs later. Similarly, the active metabolite SN-38 was detected in the pleural fluid 1.5 hr after the begining of intravenous infusion, and SN-38 concentration in the pleural fluid was almost as high as that in plasma 24 hrs later. These results suggest that intravenously administered CPT-11 may penetrate the thoracic cavity and may be metabolized to SN-38 there. The proportions of maximum concentrations of CPT-11 and SN-38 in the pleural fluid to the corresponding plasma levels were 20.4% and 28.5%, respectively. In addition, the AUCs of the lactone form SN-38 were much lower than those of the carboxyl form in the pleural fluid.CPT-11, SN-38 and SN-38 glucronide showed similar pharmacokinetics in the pericardium as that in plasma.