QT PRODACT : Inter-facility Variability in Electrocardiographic and Hemodynamic Parameters in Conscious Dogs and Monkeys
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概要
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In safety pharmacology studies, the effect of a test compound on the electrocardiogram is routinely examined by using conscious dogs. However, the results may be widely variable. The monkey, on the other hand, has scarcely been used for such studies; and as yet, there have not been reported studies on monkeys conducted at several facilities with a standard protocol. In the present study, we examined inter-facility variabilities in electrocardiographic and hemodynamic parameters as described below. We analyzed the data from 8 facilities (9 test groups) on dogs and 5 facilities (7 test groups) on monkeys. This data was obtained from the studies employing the following standard protocol: dl-Sotalol or a vehicle (0.5 w/v% methylcellulose solution) was given to animals; and the PR interval, QRS duration, QT interval, heart rate, and mean blood pressure were determined time-sequentially before and after administration of the vehicle or dl-sotalol in each test group. dl-Sotalol produced a prolongation of the maximum mean QTcF interval in conscious dogs and QTcB interval in conscious monkeys by more than 10% in every test group. No difference in the corrected QT interval among the test groups was observed in dogs, but a difference was observed in monkeys. Supplementary material (Appendix): available only at http://dx.doi.org/10.1254/jphs.QT-B6
- 社団法人 日本薬理学会の論文
- 2005-12-31
著者
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Yamamoto Keiji
日本製薬工業協会
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Yamamoto Keiji
Development Research Center Takeda Pharmaceutical Co. Ltd.
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Yamamoto Keiji
Non-clinical Evaluation Subcommittee Drug Evaluation Committee Japan Pharmaceutical Manufactures Ass
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SASAKI Hiroyuki
Research Department, Saitama Daiichi Pharmaceutical Co., Ltd.
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SHIMIZU Noritsugu
Kobuchisawa Laboratories, Fuji Biomedix Co., Ltd.
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SUGANAMI Hideki
Biostatistics and Data Management Department, Kowa Co., Ltd.
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Yamamoto Keiji
Development Research Center Takeda Pharmaceutical Co.
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Yamamoto Keiji
Drug Safety Research Laboratories Tanabe Seiyaku Co. Ltd.
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Kii Yoshihide
Safety Research Laboratories Dainippon Sumitomo Pharma Co. Ltd.
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Suganami Hideki
Biostatistics And Data Management Department Kowa Co. Ltd.
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Yamada Kiyoshi
Pharmaceutical Research Laboratories Toray Industries Inc.
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Suganami Hideki
Research Department Saitama Daiichi Pharmaceutical Co. Ltd.
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Shimizu Noritsugu
Kobuchisama Laboratories Fuji Biomedix Co. Ltd.
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Sasaki Hiroyuki
Research Department Saitama Daiichi Pharmaceutical Co. Ltd.
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Yamamoto Keiji
Non-clinical Evaluation Subcommittee Drug Evaluation Committee Japan Pharmaceutical Manufactures Ass
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