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 35, Issue 6
Displaying 1-12 of 12 articles from this issue
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  • [title in Japanese]
    [in Japanese]
    2004 Volume 35 Issue 6 Pages 269
    Published: November 30, 2004
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.35.6_269
    JOURNAL FREE ACCESS
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  • [title in Japanese]
    [in Japanese]
    2004 Volume 35 Issue 6 Pages 271-274
    Published: November 30, 2004
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.35.6_271
    JOURNAL FREE ACCESS
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  • [title in Japanese]
    [in Japanese]
    2004 Volume 35 Issue 6 Pages 275-279
    Published: November 30, 2004
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.35.6_275
    JOURNAL FREE ACCESS
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  • [title in Japanese]
    [in Japanese], [in Japanese], [in Japanese]
    2004 Volume 35 Issue 6 Pages 280-284
    Published: November 30, 2004
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.35.6_280
    JOURNAL FREE ACCESS
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  • [title in Japanese]
    [in Japanese], [in Japanese], [in Japanese]
    2004 Volume 35 Issue 6 Pages 285-289
    Published: November 30, 2004
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.35.6_285
    JOURNAL FREE ACCESS
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  • Pharmacokinetic Evaluation of Anticonvulsants in a Patient with Porphyria
    Masanori OHMOTO, Etsuko UEJIMA, Kyoko TAKAHASHI, Kazuo ABE, Saburo SAK ...
    2004 Volume 35 Issue 6 Pages 291-296
    Published: November 30, 2004
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.35.6_291
    JOURNAL FREE ACCESS
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    The aim of this study was to establish the appropriate regimen of anticonvulsants for a female patient with porphyria by pharmacokinetic evaluation of the influence of anticonvulsants on porphyria. The pharmacokinetics of phenytoin, carbamazepine, clonazepam, and clobazam were estimated by the Bayesian method. The urinary 6β-hydroxycortisol/cortisol (6β-0HF/F) ratio was also evaluated as an index of hepatic CYP3A4 induction.
    The phenytoin concentrations in the toxic area fitted the predicted value for CYP2C9* 1/*3 better than that for CYP2C9*1/*1 (her genotype). The concomitant phenytoin altered the clearance of carbamazepine considerably. The clearances of clonazepam and clobazam were not altered, although hepatic CYP3A4 induction was implied from the value of the urinary 6β-OHF/F ratio.
    From the pharmacokinetic evaluations, the following were concluded: (1) phenytoin was not the proper medication for this patient, (2) carbamazepine can be used safely within a relatively small dose, 500 mg/day, (3) the combination of clonazepam and carbamazepine can be used, and (4) a concomitant small dose of clobazam with carbamazepine can also be used.
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  • Evaluation of Deviation from Protocol in Osaka University Hospital
    How to Reduce the Deviation
    Mami IWASAKI, Yoshiko IWAMOTO, Hiroko SHIGEMATSU, Fumiko SAITO, Hajime ...
    2004 Volume 35 Issue 6 Pages 297-303
    Published: November 30, 2004
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.35.6_297
    JOURNAL FREE ACCESS
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    We investigated deviations reported between April 1, 2002 and March 31, 2003 at Osaka Univ. Hospital. The causes of deviations were identified as investigators/institution (32 cases; 54.2%), subjects (23 cases; 39.0%), and sponsors (4 cases; 6.8%). The deviations were classified as predictable deviations (13 cases; 22.0%), inadvertent deviations (25 cases; 42.4%), deviations identified during source document verification (SDV) (14 cases; 23.7%), and deviations identified after SDV (7 cases; 11.9%). The predictable deviations were generally caused by adverse events or delays in schedules. The inadvertent deviations included insufficient laboratory data and poor medication compliance. The deviations identified during SDV included incomplete understanding of the protocol and poor medication compliance. These deviations occurred during the trials, but the investigators and their trial personnel were not aware of the deviations. During SDV, the monitor communicated such deviations to the investigators. The deviations identified after SDV were caused by delays in schedules. They also occurred during the trial, but the sponsor did not regard them as deviations during SDV.
    Different types of deviations occurred within the same trial, suggesting that this kind of clinical trial seemed difficult to conduct in compliance with the protocol. Before the start of a clinical trial, the investigators/institution and IRB need to consider whether it can be conducted in compliance with the protocol. To reduce deviations, the investigators/institution should anticipate various types of deviations and take appropriate action to prevent them before and during the trial. The checklist of the protocol is a useful tool for such prevention.
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  • Response of Trial Subjects to the Packing Form of an Investigational Produc
    Tomoko KITAGAWA, Hiroko HORIKAWA, Kaoru HADA, Noriko MORISHITA, Shuji ...
    2004 Volume 35 Issue 6 Pages 305-310
    Published: November 30, 2004
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.35.6_305
    JOURNAL FREE ACCESS
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    In some clinical trials, the packing form of an investigational product is modified to improve the compliance or recognize it easily. However, it is not clarified whether such device is helpful to trial subjects, or whether they accept a different size packing form or a different appearance from the usual one. To elucidate which form of packing is desirable for them, we investigated their responses to the different type of the packing forms used in clinical trials of our hospital.(N=38)
    Our results indicate that the device indicating the time and the way of taking medicine directly to the packing is well accepted by the subject, and helpful for the self-check of drug administration. Portability and easy handling of the packing are requested, and further improvement is necessary. Since the subjects are quite different based on the study protocols, packing form fitted to the subjects in each study should be considered.
    Modification of the device to the packing form of an investigational product is important and effective to increase the quality of clinical trials. It is necessary to examine the packing form from the viewpoints of merits for both the subjects and the sponsor, including the convenience for the subjects.
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  • [title in Japanese]
    [in Japanese]
    2004 Volume 35 Issue 6 Pages 311-312
    Published: November 30, 2004
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.35.6_311
    JOURNAL FREE ACCESS
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  • [title in Japanese]
    [in Japanese], [in Japanese]
    2004 Volume 35 Issue 6 Pages 313-314
    Published: November 30, 2004
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.35.6_313
    JOURNAL FREE ACCESS
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  • [title in Japanese]
    [in Japanese]
    2004 Volume 35 Issue 6 Pages 315-316
    Published: November 30, 2004
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.35.6_315
    JOURNAL FREE ACCESS
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  • [title in Japanese]
    [in Japanese], [in Japanese]
    2004 Volume 35 Issue 6 Pages 317-320
    Published: November 30, 2004
    Released on J-STAGE: June 28, 2010
    DOIhttps://doi.org/10.3999/jscpt.35.6_317
    JOURNAL FREE ACCESS
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