Microdose Clinical Trial by Use of Radioisotope and Perspective of its Possible Utilization in Drug Development

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Other Title
  • ＲＩを用いたマイクロドーズ臨床試験とその創薬実用化への展望
  • RI オ モチイタ マイクロドーズ リンショウ シケン ト ソノ ソウヤク ジツヨウカ エ ノ テンボウ

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Description

Many promising PET tracers have been developed by the progress of molecular imaging research, and new era could be opened by clinical trials using investigational products labeled by RI. Guidance for microdose clinical trial issued by MHLW in June, 2008, is the regulatory basis to develop PET tracer under clinical trial by the pharmaceutical affairs law. In this review, the discussion from the aspect of regulatory science is highlighted, particularly, on the topics of guidance for microdose and exploratory IND study including sub-therapeutic dose(typeII) and therapeutic dose(typeIII), the revised GMP for investigational product including RI-labeled product, and toward guidance for microdose clinical trial for biological product. Finally, the US FDA guidance developing medical imaging drug including biological product is introduced, and then perspective of possible utilization of in vivo radiopharmaceutical agents in drug development is discussed.

Journal

  • RADIOISOTOPES

    RADIOISOTOPES 58 (3), 101-113, 2009

    Japan Radioisotope Association

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