著者

金 美恵子 橋本 健太郎 林 敬次 柳 元和 三田 康子

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.30, no.1, pp.197-198, 1999-01-31 (Released:2010-06-28)

著者

植田 国昭 加藤 順三

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.8, no.3, pp.389-395, 1977

著者

永井 尚美

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.5, pp.217-222, 2010 (Released:2010-11-25)

参考文献数

19

被引用文献数

2 1

---

Pharmacokinetics-Pharmacodynamics (PK-PD) is useful to understand the quantitative relationship between drug exposure and pharmacological outcome. In recent years, results of the pharmacokinetic analysis of Japanese patients have been frequently included in the new drug application dossier. Also, not only pharmacokinetics, there are an increasing number of cases where clarifying the relationships between pharmacokinetics and efficacy/safety data. Furthermore, PK-PD analysis has been applied to a growing range of drug development program, for example designing subsequent clinical studies using the modeling and simulation technique. The value and applied cases of PK-PD modeling and simulation in drug development have been discussing past several years, and the regulatory bodies and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) have published related documents and guidelines. The integration of information obtained during pre-clinical and early-phase clinical development and application of PK-PD modeling and simulation to a clinical drug development program is thought to be one of the powerful and scientific approaches for planning high-quality, speedy and cost-effective drug development program. However, it is a newly emerging approach especially in clinical drug development, therefore building multi-disciplinary teams, educating/training the professionals, collecting experiences to make database and intensive communication among different professionals are essential. This article reviews the current situation of this approach in Japan and regulatory point of view of the role of PK-PD modeling and simulation in drug development and approval.

著者

鈴木 哲哉

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.6, no.4, pp.307-313, 1975-12-30 (Released:2010-06-28)

参考文献数

4

著者

浜田 知久馬

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.33, no.4, pp.153-157, 2002-07-31 (Released:2010-06-28)

参考文献数

4

被引用文献数

1

著者

津谷 喜一郎 峰下 哲 富永 幸夫 佐久間 昭

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.16, no.1, pp.261-262, 1985-03-30 (Released:2010-06-28)

参考文献数

3

著者

野村 正和 後藤 弘 張 岫美

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.251S, 2004-01-31 (Released:2010-06-28)

参考文献数

3

著者

小林 真一

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.27, no.2, pp.535-540, 1996-06-30 (Released:2010-06-28)

参考文献数

4

著者

葛谷 健

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.31, no.3, pp.537-538, 2000-05-31 (Released:2010-06-28)

著者

岡元 律子 伊藤 善規 馬場 安里 村田 雄介 大石 了三 美根 和典

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.1, 2004-01-31

著者

熊谷 雄治 藤田 朋恵 横田 愼一 澤田 実花 井澤 志名野 鈴木 勇一 立岡 和弘 庄田 隆 矢後 和夫

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.5, pp.205-213, 2002-09-30 (Released:2010-06-28)

参考文献数

8

---

Objectives: Tibolone (KB-889) is a novel compound that possesses tissue-specific hormonal effects. We investigated the pharmacokinetics of tibolone in postmenopausal women in four pharmacokinetic studies, namely a dose linearity study, a multiple dose study, a study in fasted condition, and a study in elderly. In this report, the results obtained from the above four studies are summarized.Methods: In the dose linearity study, a single dose of 0.5 mg, 1 mg and 2 mg of tibolone was administered to 6 postmenopausal women using a 3-period crossover method with at least a 7-day wash-out period between treatments. In the multiple dose study, 2 mg of tibolone was administered once daily for 4 days to 6 postmenopausal women. In the study in fasted condition, a single dose of 2 mg of tibolone was administered to 6 postmenopausal women after overnight fasts. In the study in elderly, a single dose of 2 mg of tibolone was administered to 6 elderly women aged 65 or older. Plasma and urine concentrations of tibolone and its metabolites were measured.Results and Conclusion: Plasma concentrations of the 3α-OH and 3β-OH metabolites of tibolone were measured, since the levels of tibolone and its Δ4-isomer were under or near the detection limits. After single dose administration of 0.5, 1 and 2 mg of tibolone, the means of Cmax and AUC0-12h of plasma 3α-OH metabolite were 2.3, 3.5 and 6.5 ng/mL and 10.2, 18.5 and 36.7 ng·Eh/mL, respectively, and those of 3β-OH metabolites were 0.9, 1.7 and 3.1 ng/mL and 4.6, 8.8 and 17.7 ng·Eh/mL, respectively. The means of Tmax and T1/2 (6-12h) of plasma 3α-OH and 3β-OH metabolites were between 3.7 and 5.7 h, and between 3.2 and 4.4 h, respectively. The pharmacokinetic properties of tibolone were considered to be linear within the dose range of 0.5 mg to 2 mg. In the multiple dose study, no accumulation was found. When comparing the pharmacokinetic parameters obtained from the study in fasted condition with those of day 1 of the multiple dose study, the absorption of tibolone was rapid under fasted condition, but AUC was not influenced by food intake. [The means of Tmax of 3α-OH and 3β-OH metabolites were 1.17 and 1.33 h in fasted condition, and 3.83 and 4.00 h on day 1 of multiple dose.] Finally no difference in pharmacokinetics was found between postmenopausal women and elderly women in the comparison of the pharmacokinetic parameters obtained from the study in the elderly and those of day 1 of the multiple dose study.

著者

奇 錦峰 豊嶋 穆 峰下 哲

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.27, no.1, pp.251-252, 1996-03-31 (Released:2010-06-28)

著者

志賀 剛

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.44, no.6, pp.490-494, 2013-11-30 (Released:2013-12-20)

参考文献数

8

著者

中園 直子 猪爪 信夫 飛野 幸子 岩奥 玲子 中野 眞汎

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.16, no.2, pp.401-407, 1985-06-30 (Released:2010-06-28)

参考文献数

27

被引用文献数

1

---

The bioavailability of theophylline following administration of two pediatric sustained release tablets (Theona-P® and Theo-Dur®), two crushed sustained release tablets (crushed Theona-P® and crushed Theo-Dur®), and newly developed sustained release granules (E-0686-023, investigational drug) was studied in four volunteers by measuring salivary concentrations. The pharmacokinetic parameters tmax and MRT (mean residence time) for crushed Theona-P® and crushed Theo-Dur® were significantly shorter compared to Theona-P®, Theo-Dur®, and E-0686 granules, but the AUC0-∞ values were not different among them. The results show that each preparation is equivalent in the extent of bioavailability but not in the rate of bioavailability. More frequent administration is required when crushed Theona-P® or crushed Theo-Dur® are taken, and sustained release granules are desirable in children with chronic asthma who cannot swallow tablets.

著者

松永 憲和 松田 秀康 木下 香葉子 福圓 修一 新宅 紗里 福田 剛史 山本 勇 東 純一

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.33, no.1, pp.101S-102S, 2002-01-31 (Released:2010-06-28)

参考文献数

6

著者

柳田 知司

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.5, no.2, pp.125-132, 1974-06-30 (Released:2010-06-28)

参考文献数

11

著者

荒木 徹

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.175S, 2004-01-31 (Released:2010-06-28)

著者

中野 重行 菅原 英世 坂本 真佐哉 小関 哲郎 上村 尚人 丹生 聖治 角南 由紀子 松木 俊二 梅月 恵美

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.30, no.1, pp.1-7, 1999-01-31 (Released:2010-06-28)

参考文献数

8

被引用文献数

5 5

---

Objectives: A variety of factors influence the incidence of placebo effects . The purpose of this study was to clarify the influence of factors such as the doctor-patient relationship, patient's motivation and expectation for drug therapy on placebo effectsMethods: Data were obtained from two double-blind randomized clinical trials with a placebo control group of 123 patients with psychosomatic disorders. The improvement was assessed by doctors at two weeks after the initiation of treatment. The doctor-patient relationship, patient's motivation and expectation for drug therapy were assessed by doctors at the beginning of clinical trials.Results: The improvement rate in the placebo group was 42.3%, whereas the improvement rate in the diazepam group was 57.6% (p <0.05). In the placebo group, improvement rates were 50.0% in patients with a good doctor-patient relationship, 31.4% in patients with a moderate relationship and 10.0% in patients with a poor relationship (p < 0.05).Improvement rates were 46.1% in patients with a good motiva-tion for drug therapy and 19.0% in patients with poor or lack of motivation (p <0.01).Improvement rates were 36.4% in patients with low expectation for drug therapy, 53.0% in patients with a moderate one, and 7.7% in patients with high expectation (p <0.05).Conclusion: In patients with psychosomatic disorders, factors such as the doctor-patient relationship, patient's motivation and expectation for drug therapy clearly influ-ence the incidence of placebo effects.

著者

田村 豊幸

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.4, no.2, pp.119-123, 1973-06-30 (Released:2010-06-28)

参考文献数

8

著者

Iori SAKAKIBARA Kazuki IDE Yohei KAWASAKI

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.48, no.3, pp.95-98, 2017-05-31 (Released:2017-06-21)

参考文献数

10

---

The National Center Biobank Network (NCBN) was launched in Japan in 2012 and currently comprises the biobanks of six national centers. The NCBN collects and controls information of patients' biological specimens along with a supplemental catalog of disease names, medical examinatian forms, and diagnostic information. However, these data do not comply with universal standard data formats. In this study, we investigated the possibility of data sharing or collaboration between the NCBN and other biobanks, and whether the data collected and controlled at the NCBN can be standardized following the international standard guidelines of the Clinical Data Interchange Standards Consortium (CDISC) to allow use of these data in future clinical studies. We also evaluated whether data mapped to the Study Data Tabulation Model (SDTM), a standard specification regulated under the CDISC, can be converted to Analysis Data Models (ADaMs) to facilitate searches for the feasibility of data adaptation to clinical trials, and determined the advantages and drawbacks of this conversion. In addition, we examined the potential of utilizing standardized data sets in clinical trials. As a result, we classified the 202 NCBN catalog data items into seven SDTM domains, which were subsequently converted into four ADaM domains. While we expect that conversion of NCBN catalog data to ADaM is possible, the NCBN catalog data currently lack items that can be utilized in actual clinical trials. Thus it is necessary to retain the medical data required for clinical trials at each national center. Standardization of these data is essential, but is currently difficult given the lack of standard clinical trial protocols. Thus, standardization of the data at national center would help promote their usage for planning clinical trials.