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Parameter-finding studies of photodynamic therapy for approval in Japan and the USA

机译：在日本和美国进行光动力疗法参数寻找研究的批准

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摘要

Objective: The purpose of this study is to investigate methods of evaluating therapeutic parameters used in the premarket evaluation of photodynamic therapy (PDT) drugs that have previously been approved in Japan and the United States, in order to establish a methodology that allows optimization of the therapeutic parameters of PDT, and to analyze current issues. Materials and Methods: We examined the details of premarket evaluation of drug dose, drug-light intervals, as well as wavelengths, power density, and energy density of illumination sources used for the PDT drugs that have been approved in Japan the United States. Results: There was a tendency for optimal drug dose and light energy density to be assessed in clinical studies. Drug-light intervals were assessed in the United States in clinical studies, and in Japan only in non-clinical studies. For various drugs, drug-light intervals were assessed based on fluorescence. For most drugs, the wavelength at which the drug can be photo-activated was determined in non-clinical studies. We found only few examples regarding the optimization of light power density as compared to the other therapeutic parameters. Conclusions: Drug dose, drug-light interval, and light energy density are particularly important parameters with regard to the efficacy and safety of PDT drugs. In order to determine the optimal therapeutic parameters of PDT more effectively, appropriate clinical studies need to be designed. Also the use of biomedical engineering, such as fluorescence measurement, is effective for optimizing PDT therapeutic parameters. We believe that in the future there will be a greater number of regulatory science related studies like ours will lead to the further spread of PDT.
机译：目的：本研究的目的是研究在日本和美国之前已批准的光动力疗法（PDT）药物的上市前评估中所使用的评估治疗参数的方法，以便建立可优化药物治疗的方法。 PDT的治疗参数，并分析当前问题。材料和方法：我们检查了上市前评估药物剂量，药物光间隔以及波长，功率密度和用于日本的PDT药物的照明光源的能量密度的详细评估，这些药物已在日本日本获得批准。结果：在临床研究中有评估最佳药物剂量和光能密度的趋势。在美国，仅在临床研究中评估了药物间隔时间，在日本仅在非临床研究中进行了评估。对于各种药物，根据荧光评估药物间隔。对于大多数药物，可以在非临床研究中确定可以光激活药物的波长。与其他治疗参数相比，我们仅发现了几个有关光功率密度优化的例子。结论：就PDT药物的有效性和安全性而言，药物剂量，药物光间隔和光能密度是特别重要的参数。为了更有效地确定PDT的最佳治疗参数，需要设计适当的临床研究。同样，使用生物医学工程，例如荧光测量，对于优化PDT治疗参数也是有效的。我们相信，将来像我们一样，将会有更多与监管科学相关的研究导致PDT的进一步普及。

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  • 来源
    《Photodiagnosis and Photodynamic Therapy》 |2013年第4期|434-445|共12页
  • 作者

    Yuki Kawase; Hiroshi lseki;

  • 作者单位

    Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo Women's MedicalUniversity and Waseda University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan,Corporate Research & Development Center, Panasonic Healthcare Co., Ltd., 600 Saedo-cho, Tsuzuki-ku,Yokohama 224-0054, Japan;

    Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo Women's MedicalUniversity and Waseda University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan,Institute of Advanced Biomedical Engineering and Science, Tokyo Women's Medical University,8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan;

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  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类
  • 关键词

    Photodynamic therapy; Regulatory science; Therapeutic parameter;

    机译：光动力疗法;监管科学;治疗参数;

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