11:20 AM - 11:35 AM
[3M07] R&D on Medical RI production using domestic nuclear infrastructures to achieve self-preparedness (2)
(7) Manufacturing conditions for medical use of 225Ac
Keywords:Nuclear Medicine
A drug master file (DMF) is a document that domestic or foreign manufacturers of drug substances submit as an information for theire manufacturing methods, manufacturing control, quality control, etc. As a result, manufacturers of drugs can apply for approval without disclosing information about drug substances.
In order to spread the research and development of 225Ac for medical use that manufactured in nuclear reactors in Japan, it is the best way that manufacturers of 225Ac for medical use register it with the DMF.
We discussed the quality requirements for 225Ac derived from nuclear reactors based on the quality requirements for 225Ac that have already been clinically applied in Europe and the United States.
In order to spread the research and development of 225Ac for medical use that manufactured in nuclear reactors in Japan, it is the best way that manufacturers of 225Ac for medical use register it with the DMF.
We discussed the quality requirements for 225Ac derived from nuclear reactors based on the quality requirements for 225Ac that have already been clinically applied in Europe and the United States.
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