Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
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Volume 37, Issue 6
Displaying 1-9 of 9 articles from this issue
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  • [title in Japanese]
    [in Japanese]
    2006 Volume 37 Issue 6 Pages 323
    Published: November 30, 2006
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.37.6_323
    JOURNAL FREE ACCESS
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  • 1. Activities at FDA
    Drug Use in Pregnancy and Lactation
    Kathleen Uhl
    2006 Volume 37 Issue 6 Pages 324-330
    Published: November 30, 2006
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.37.6_324
    JOURNAL FREE ACCESS
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    Many women experience medical problems during pregnancy and while breast-feeding that require chronic or episodic treatment with prescription medication. Pregnant and lactating women are typically excluded from clinical drug trials. At the time of a drug's initial marketing, there are seldom meaningful human data on the effects of that drug during pregnancy and lactation. Even after years of marketing, data in product labeling regarding use during pregnancy and lactation rarely go beyond the data available at the time of initial marketing.
    This paper will describe FDA's approach to pregnant and lactating women including revising regulations for labeling and guidance documents for industry and reviewers pertinent to the collection and interpretation of data in pregnant and lactating women. The consistent application of adequate study designs would improve the data available regarding drug use during pregnancy and lactation. The goal of improved labeling is to provide clinically useful information that aids the health care provider and patient in making decisions about drug use during pregnancy and lactation.
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  • [title in Japanese]
    [in Japanese]
    2006 Volume 37 Issue 6 Pages 331-337
    Published: November 30, 2006
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.37.6_331
    JOURNAL FREE ACCESS
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  • [title in Japanese]
    [in Japanese]
    2006 Volume 37 Issue 6 Pages 338-341
    Published: November 30, 2006
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.37.6_338
    JOURNAL FREE ACCESS
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  • [title in Japanese]
    [in Japanese]
    2006 Volume 37 Issue 6 Pages 343-345
    Published: November 30, 2006
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.37.6_343
    JOURNAL FREE ACCESS
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  • [title in Japanese]
    [in Japanese], [in Japanese]
    2006 Volume 37 Issue 6 Pages 347-352
    Published: November 30, 2006
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.37.6_347
    JOURNAL FREE ACCESS
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  • Effect of Meal on the Pharmacokinetics of Rifampicin
    Takahiro NISHIMURA, Haruichi KOHNO, Atuyuki KURASHIMA, Hiroaki KUBO, Y ...
    2006 Volume 37 Issue 6 Pages 353-357
    Published: November 30, 2006
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.37.6_353
    JOURNAL FREE ACCESS
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    Rifampicin (RFP) is one of the first-line drugs in the treatment of tuberculosis. Worldwide, the recommended administration of RFP is before breakfast, however it is commonly administered after the meal in Japan. It is known that the absorption of RFP is affected by a meal. Therefore, the effects of meal on the pharmacokinetics of rifampicin were studied in patients with tuberculosis.
    Ten male patients participated in this study. Five of the ten patients were given three capsules (450mg of RFP) 30 minutes before breakfast. The other five patients were given the same dose of RFP 30 minutes after breakfast. The mean age and weight were 54.6±3.3 years and 53.9±2.7kg in the group before meal and in the after the meal group, 49.8±8.4 years and 53.8±5.0kg, respectively. All the data were expressed as mean±S.D. Blood samples were taken at 0, 2, 4 and 6 hours after capsule administration. RFP concentra tions in serum were analyzed by reversed-phase high performance liquid chromatography and the relevant pharmacokinetic parameters were calculated. Group means were compared by use of nonparametric statis tics.
    In the group before meal, the peak concentration (Cmax) was significantly higher than that in the group after meal (9.32±0.88μg/mL versus 5.76 ± 1.04 μg/mL, p<0.05) and the AUC was also significantly higher than that in the group after meal (35.83±3.29μg/hr/mL versus 18.63±4.35μg/hr/mL, p<0.05). These results suggest that RFP should be taken 30 minutes before the meal.
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  • CYP2C19
    [in Japanese], [in Japanese], [in Japanese], [in Japanese], [in Japane ...
    2006 Volume 37 Issue 6 Pages 359-366
    Published: November 30, 2006
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.37.6_359
    JOURNAL FREE ACCESS
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  • [title in Japanese]
    [in Japanese]
    2006 Volume 37 Issue 6 Pages 367-368
    Published: November 30, 2006
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.37.6_367
    JOURNAL FREE ACCESS
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