ArticleInvestigational new drugs2014
Differences in maximum tolerated doses and approval doses of molecularly targeted oncology drug between Japan and Western countries.
Article in Investigational new drugs, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
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Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Trends of Phase I Clinical Trials of New Drugs in Mainland China Over the Past 10 Years (2011-2020).Frontiers in medicine · 2021Pooled it
- Impact of race on dose selection of molecular-targeted agents in early-phase oncology trials.British journal of cancer · 2018Trial
- Global regulatory variability in small-molecule inhibitor approvals: Differences in timelines, dosing, and pediatric indications across FDA, EMA, and PMDA.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Article
- Assessment of Surrogate End Point Trends in Clinical Trials to Approve Oncology Drugs From 2001 to 2020 in Japan.JAMA network open · 2023Article
- Surveys/Research Exploring Japanese Phase I Studies in Global Drug Development: Are They Necessary Prior to Joining Global Clinical Trials?Clinical pharmacology in drug development · 2021Article
- Estimating Similarity of Dose-Response Relationships in Phase I Clinical Trials-Case Study in Bridging Data Package.International journal of environmental research and public health · 2021Article
- An adaptive power prior for sequential clinical trials - Application to bridging studies.Statistical methods in medical research · 2020Article
- The drug lag and associated factors for orphan anticancer drugs in Japan compared to the United States.Investigational new drugs · 2019Article
- Unique characteristics of regulatory approval and pivotal studies of orphan anticancer drugs in Japan.Investigational new drugs · 2018Article
- Precision medicine: does ethnicity information complement genotype-based prescribing decisions?Therapeutic advances in drug safety · 2018Review
- Toward Optimum Benefit-Risk and Reduced Access Lag For Cancer Drugs in Asia: A Global Development Framework Guided by Clinical Pharmacology Principles.Clinical and translational science · 2016Review
- Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan?International journal of clinical oncology · 2015Article
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
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 (12.5 %) of the 40 drugs had different approved dose from that in the US and the EU. Of the 13 cytotoxic drugs, four drugs (30.8 %) 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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