The Japanese Journal of Antibiotics
Online ISSN : 2186-5477
Print ISSN : 0368-2781
ISSN-L : 0368-2781
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Volume 54, Issue 12
Displaying 1-3 of 3 articles from this issue
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  • BACTERICIDAL ACTIVITY OF BIAPENEM AGAINST VARIOUS BACTERIA
    TOORU HIRAISHI, AIKO MIYATA, TETSURO HARA, MINAKO ARAAKE, HIROSHI OGAW ...
    2001 Volume 54 Issue 12 Pages 581-595
    Published: December 25, 2001
    Released on J-STAGE: May 17, 2013
    DOIhttps://doi.org/10.11553/antibiotics1968b.54.581
    JOURNAL FREE ACCESS
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    The bactericidal activity of biapenem (BIPM), a new carbapenem agent, against Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa and Serratia marcescens was compared with those of imipenem (IPM), panipenem (PAPM), meropenem (MEPM) and ceftazidime (CAZ). The bactericidal activity of BIPM against S. aureus was equal to those of IPM, PAPM and MEPM. Against E. coli and K. pneumoniae, BIPM showed higher bactericidal activity than IPM and PAPM. Against P. aeruginosa, BIPM showed excellent bactericidal activity campared with IPM. The killing speeds of BIPM and IPM were obviously the most rapid among four carbapenems. BIPM showed a strong bactericidal activity against 5 species of bacteria including P. aeruginosa.
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  • THE PROBLEM OF POST-MARKETING SURVEILLANCE PLANNING ON DRUGS FOR INFECTIOUS DISEASE
    JUNKO SATO
    2001 Volume 54 Issue 12 Pages 596-604
    Published: December 25, 2001
    Released on J-STAGE: May 17, 2013
    DOIhttps://doi.org/10.11553/antibiotics1968b.54.596
    JOURNAL FREE ACCESS
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    In principle, a new drug is approved via the assessments of safety and efficacy by the Ministry of Health,Labor and Welfare (MHLW). After approval, conduct of post-marketing surveillance is requested by law in order to assess the safety and efficacy of the drug in a large number of patients. Before initiating a surveillance, submission to MHLW of a document on the plan of survey is necessary in the purpose of inspection if it includes any ethical or regulatory problem or not. Through the inspections of the plans submitted during the period of April 1998 and March 2000, many problems have been pointed out. In this report, the author introduces some of the concrete problems noted in the plans on drugs for infectious diseases and shows some of the guidance made by the authority how to improve them.It is expected that such practical analyses of cases may be useful for future planning of post-marketing surveillance on drugs for infectious diseases.
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  • [title in Japanese]
    [in Japanese], [in Japanese], [in Japanese], [in Japanese]
    2001 Volume 54 Issue 12 Pages 605-630
    Published: December 25, 2001
    Released on J-STAGE: May 17, 2013
    DOIhttps://doi.org/10.11553/antibiotics1968b.54.605
    JOURNAL FREE ACCESS
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