巻号一覧
36 巻 (2005)
- 6 号 p. 265-
- 5 号 p. 219-
- 4 号 p. 165-
- 3 号 p. 109-
- 2 号 p. 45-
- 1 号 p. 1-
36 巻, 6 号
選択された号の論文の12件中1～12を表示しています
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第36巻第6号特集/神経疾患治療薬の現状と今後の開発野元 正弘2005 年 36 巻 6 号 p. 265
発行日: 2005/11/30
公開日: 2010/06/28
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松原 悦朗, 東海林 幹夫2005 年 36 巻 6 号 p. 266-272
発行日: 2005/11/30
公開日: 2010/06/28
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永井 将弘, 野元 正弘2005 年 36 巻 6 号 p. 273-276
発行日: 2005/11/30
公開日: 2010/06/28
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中島 健二, 竹島 多賀夫2005 年 36 巻 6 号 p. 277-283
発行日: 2005/11/30
公開日: 2010/06/28
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有村 公良2005 年 36 巻 6 号 p. 284-288
発行日: 2005/11/30
公開日: 2010/06/28
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Yuri SHIDA, Shigeru NOHDA, Annette S GROSS, Jonathan L PALMER, Kentaro ...2005 年 36 巻 6 号 p. 289-296
発行日: 2005/11/30
公開日: 2010/06/28
ジャーナル フリーThe pharmacokinetics of adefovir dipivoxil, a novel reverse transcriptase inhibitor for the treatment of chronic hepatitis B, were investigated in healthy Japanese subjects (n=12) and Japanese patients with chronic hepatitis B (n=11).
Healthy males received single and multiple doses (once daily for 5 days) of adefovir dipivoxil 10 mg. After the first and final doses, blood and urine samples were collected over 48 hours and concentrations of adefovir, the hydrolysed active metabolite, measured by LC-MS/MS. Adefovir pharmacokinetic parameters (mean±SD) were comparable after single and multiple dosing: Cmax 22.9±3.3 and 24.5±3.8 ng/mL, respectively. The single dose AUC 0-∞ (239.4±35.7 ng·hr/mL) and half-life (6.89±1.21 hr) were also similar to AUC 0-24 (249.3±32.9 ng·hr/mL) and t 1/2 (7.73±0.73 hr) after multiple dosing. The steadystate accumulation ratio was 1.05±0.12, indicating a lack of appreciable accumulation during multiple dosing. Approximately 60% of the dose was recovered in urine as adefovir.
Chronic hepatitis B patients with evidence of abnormal liver function associated with YMDD mutant hepatitis B virus and taking lamivudine 100 mg once daily were also studied. The results were similar to those in healthy subjects. Cmax and AUC 0-∞ after the first dose of adefovir dipivoxil 10 mg in chronic hepatitis B patients were 20.1±3.3 ng/mL and 272.8±51.3 ng·hr/mL, respectively. Furthermore, the pharmacokinetics of adefovir were comparable in patients with and without cirrhosis. Adefovir pharmacokinetics in Japanese subjects with normal renal function are therefore not altered by chronic hepatitis B infection, lamivudine co-administration or the severity of hepatic disease. These Japanese results are consistent with those in Western subjects and a major inter-ethnic difference is not observed.抄録全体を表示PDF形式でダウンロード (1279K) -
公共ヒト組織バンクへ組織提供する医療機関としての取組み中谷 祥子, 櫻井 史穂子, 熊井 俊夫, 武半 優子, 田中 政巳, 松本 直樹, 松井 宏晃, 中野 浩, 朝倉 武士, 野田 真一郎, ...2005 年 36 巻 6 号 p. 297-303
発行日: 2005/11/30
公開日: 2010/06/28
ジャーナル フリーSince the importance of human tissue in the research for therapeutics and drug development has been widely recognized, the frequency of human tissue use for research has increased. The Human Science Research Resources Bank (HSRRB) has been established by the Japan Health Sciences Foundation as the first bank of human tissue for research in Japan. This public bank supplies human tissues for medical research to the scientists in Japan. To collect the human tissue for this bank, St. Marianna University School of Medicine has established an in-house institutional bank system as the human tissue supplier. The job clinical research coordinator, and a newly formatted informed consent and masking system of personal information by a special security manager have all been introduced, and high-quality tissue storage was installed for this system. The details of our system is described in the present paper; the problems encountered and countermeasures for such problems are also discussed.抄録全体を表示PDF形式でダウンロード (1086K) -
国立大学法人附属病院におけるアンケート調査山本 雅人, 鍋島 俊隆2005 年 36 巻 6 号 p. 305-313
発行日: 2005/11/30
公開日: 2010/06/28
ジャーナル フリーIt is likely that requests from hospital pharmacists to pharmaceutical companies are increasing with the greater sophistication and diversification of hospital pharmacist's practice in recent years. However, there is no nation-wide information concerning the requests to pharmaceutical companies. We surveyed the requests from hospital pharmacists to research laboratories of pharmaceutical companies by questionnaire. The questionnaires were sent to 42 national university hospitals, and 129 replies were received from pharmacists of 28 hospitals. Highly placed requests regarding drug developments included commercialization of in-hospital preparations (15.5%), commercialization of dosage forms taken easily (13.2%), improvement of packaging of medical products (24.8%), the addition of doses (19.4%) and expansion of therapeutic use of narcotics (8.6%). Hospital pharmacists requested a wide variety of information regarding effectiveness, safety, drug interactions, contraindication, instruction for use, patient instruction and guidelines. In the response calculations, 91.5 percent of hospital pharmacists wished to take part in drug development, but 68.2% of hospital pharmacists did not have contact with the research and development departments of pharmaceutical companies. These results suggest that it is necessary to establish close and bilateral exchange between hospital pharmacists and research and development departments of pharmaceutical companies in order to realize unmet hospital pharmacist's requests.抄録全体を表示PDF形式でダウンロード (5106K) -
櫻井 史穂子, 松本 直樹, 長谷川 節雄, 河野 純, 入江 伸, 竹元 直行, 中村 紘一, 越村 典子, 深瀬 広幸, 田中 克孝, ...2005 年 36 巻 6 号 p. 315-322
発行日: 2005/11/30
公開日: 2010/06/28
ジャーナル フリーAfter the renovation of Good Clinical Practice (GCP), the industrial sponsors and medical institutions have improved their practice. However, the clinical trials greatly depend upon the understanding and cooperation of participating volunteers. The survey of Kobayashi et al. on Phase II/III Trials, revealed that participating patients generally had a good impression. We conducted a questionnaire on healthy volunteers to clarify whether a difference may exist.
Those who participated in a Phase I Trial after April 2001 at the six participating institutions were enrolled in the study. The questionnaire covered 31 topics related to the impression before and after participating in their first trial, general impression on the trial and others from between October 2004 and January 2005. Analysis of the data (without personal information) was conducted at St. Marianna University.
Healthy volunteers had almost the same impression of Clinical Trials as diseased patients in Phase II/III Trails. The study revealed that they wished for trials for new drug development to widely inform the public, and be carried out safely, but also in an active manner. We concluded that it is important to keep ourselves attentive to the public/volunteer opinion, and to continue to carry out good practice in Clinical Trials with a good relationship between and cooperation of volunteers and patients.抄録全体を表示PDF形式でダウンロード (1250K) -
規制の解釈と実施可能性中垣 直美2005 年 36 巻 6 号 p. 323-325
発行日: 2005/11/30
公開日: 2010/06/28
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医療現場の状況と方向性内田 英二2005 年 36 巻 6 号 p. 326-328
発行日: 2005/11/30
公開日: 2010/06/28
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中野 眞汎2005 年 36 巻 6 号 p. 329-331
発行日: 2005/11/30
公開日: 2010/06/28
ジャーナル フリーPDF形式でダウンロード (2861K)
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