ArticleClinical and translational science2019
Analysis of Global Drug Development Pathways and Postmarketing Safety in Japan: Local Studies May Reduce Drug-Related Deaths.
Article in Clinical and translational science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed, 5 citations in OpenAlex.
- Safety and Pharmacokinetics of Olamkicept Doses up to 2400 mg in Healthy Japanese Men: Phase I, Randomized, Placebo-Controlled, and Double-Blind Trial.Clinical and translational science · 2026Trial
- Evaluation of Drug Lags in Development Initiation, New Drug Application and Approval Between Japan and the USA and the Impact of Local Versus Multi-regional Clinical Trials.Pharmaceutical medicine · 2021Article
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Authors and funding
2 authors at 1 institution in 1 country.
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Abstract
Recent International Conference on Harmonization (ICH) guidelines provide pharmaceutical companies with regulatory justifications to pursue various global drug-development pathways, in some of which "local" dose-ranging and/or pivotal phase III studies are skipped. We examined the association between the clinical development pathway and postmarketing safety in Japan for 177 new molecular entities approved between 2004 and 2013 focusing on dose setting histories for each drug. The risk of drug-related deaths was higher when companies did not conduct local (i.e., Japanese) dose-ranging studies and/or pivotal studies. Even when local dose-ranging studies were conducted, the risk remained higher in some drugs for which the approved dose in Japan was set equal to that in the United States. Drugs developed under a bridging strategy tended to show lower risks. These results suggested that local clinical studies may play a substantial role in achieving optimization of postmarketing drug use in each local target population.
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