Differences between Japan and the United States in dosages of drugs recently approved in Japan

Journal of Clinical Pharmacology
K NakashimaM Takeuchi

Abstract

The internationalization of clinical and regulatory guidelines and disease treatment and the globalization of the pharmaceutical industry have led drug development strategies in Japan to shift from bridging studies to multinational trials. However, the current standard for adequate dose-finding processes may sometimes complicate the timely participation of Japan in these multinational trials. The objective of this study is to investigate different factors that might influence dosage selection in Japan. Approved drug dosages in Japan and the United States during the period 2003-2008 were compared and assessed across different therapeutic areas and approval timings. Factors such as company type and daily dosage indication were demonstrated to have a statistically significant relationship with different dosages in Japan and the United States. Anticancer, antiviral, and enzyme drugs showed similar dosages in the 2 regions, whereas neurological drugs were observed to undergo more careful dosage-finding processes, resulting in the approval of generally lower doses in Japan. A broader analysis is needed for detailed assessment. The findings in this study serve as an initial review to identify important factors that should be considere...Continue Reading

References

Jan 1, 1992·Critical Reviews in Toxicology·S A Wrighton, J C Stevens
Mar 27, 2001·Annual Review of Pharmacology and Toxicology·H G XieC M Stein
Nov 13, 2002·Pharmacoepidemiology and Drug Safety·H A J Struijker Boudier
Nov 13, 2002·Pharmacoepidemiology and Drug Safety·James CrossCarl Peck
Nov 13, 2002·Pharmacoepidemiology and Drug Safety·Eibert R HeerdinkHubert G Leufkens
Dec 31, 2002·Journal of Diabetes and Its Complications·Nicola Abate, Manisha Chandalia
Sep 3, 2004·Journal of Clinical Pharmacology·Kiman KimHartmut Derendorf
Nov 30, 2006·Annals of the New York Academy of Sciences·Yongsoo Park
Nov 30, 2006·Annals of the New York Academy of Sciences·Hiroshi IkegamiToshio Ogihara
Jun 16, 2007·Clinical Pharmacology and Therapeutics·C C Peck, J T Cross
Jun 6, 2008·Journal of Clinical Pharmacology·Henry J MalinowskiTing Ong
Sep 17, 2008·The Review of Diabetic Studies : RDS·Hiroshi IkegamiYumiko Kawabata
Feb 3, 2009·Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan·Kazuhiko Nakajima
Apr 23, 2010·Clinical Pharmacology and Therapeutics·F L ArnoldS Ono

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Citations

Jan 11, 2018·Therapeutic Advances in Drug Safety·Rashmi R Shah, Andrea Gaedigk
Nov 28, 2013·Clinical Pharmacology and Therapeutics·F L ArnoldS Ono
Jul 20, 2016·Nihon yakurigaku zasshi. Folia pharmacologica Japonica·Yoshiaki Uyama
Sep 30, 2017·Annual Review of Pharmacology and Toxicology·Richard W Peck
Jun 13, 2020·International Journal of Hematology·Takashi IkedaYoshinobu Kanda
Feb 13, 2021·British Journal of Clinical Pharmacology·Catarina AbrantesFernando Fernandez-Llimos

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