Differences in maximum tolerated doses and approva

Authors: Hideki Maeda Tatsuo Kurokawa

Publish Date: 2014/03/11

Volume: 32, Issue: 4, Pages: 661-669

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Abstract

Approved doses of a number of drugs in Japan are known to be different from those in the United States US and the European Union EU and doses are often set lower for the Japanese than for the western people Similarly some oncology drugs also have lower dose approved for the Japanese than for the western people A total of 40 oncology drugs were approved as new molecular entities in Japan between 2001 and 2013 Of the 40 drugs 21 were molecularly targeted drugs and 13 were cytotoxic drugs Five 125  of the 40 drugs had different approved dose from that in the US and the EU Of the 13 cytotoxic drugs four drugs 308  differed in approved dose while all the molecularly targeted drugs 21 of 21 drugs had the same approved dose We compared the maximum tolerated dose MTD of the 21 molecularly targeted drugs in the Japanese with that in the western people and found that the MTD was determined lower in the Japanese than that in the western people two drugs was not different 10 drugs and MTD was not determined in the Japanese and incommensurable because of the different dose range tested in Japan nine drugs All the molecularly targeted drugs are the same in approved doses and few molecularly targeted drugs differ in MTD between Japan and the Western countries

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