HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:
Sign In to gain access to subscriptions and/or personal tools.

This Article Full Text Full Text (PDF) All Versions of this Article: 0091270008319794v1 48/8/900    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Request Reprints Citing Articles Citing Articles via Web of Science (1) Citing Articles via Google Scholar Google Scholar Articles by Malinowski, H. J. Articles by Ong, T. Search for Related Content PubMed PubMed Citation Articles by Malinowski, H. J. Articles by Ong, T. Social Bookmarking                         What's this?

Same Drug, Different Dosing: Differences in Dosing for Drugs Approved in the United States, Europe, and Japan

From the US Food and Drug Administration, Rockville, Maryland (Ms. Ong, Dr Malinowski [retired]); Pharmaceutical and Medical Devices Agency, Tokyo, Japan (Dr Sato); and Hoffmann-LaRoche, Nutley, New Jersey (Dr Westelinck).

With globalization of the pharmaceutical industry, newly approved drugs nearly always become available worldwide, including the 3 major pharmaceutical regions: the United States, Europe, and Japan. One might think that these drugs would have the same recommended dosing throughout the world, but this appears not to be true in many instances. The objective of this study was to identify any patterns of differences in labeled dosing. Approved labeling, for the most widely prescribed proprietary drugs in the United States, was used as a basis for this study. Dosing was compared, for common indications, for the United States, Europe, and Japan. Overall, these data indicate that there are numerous differences in approved dosing for drugs approved in all 3 regions. For about half of the drugs studied, dosing in Japan is considerably lower than the United States or Europe. Some differences in dosing are also apparent between the United States and Europe.

Key Words: International • dosing • regulatory decisions • exposure response • drug safety

Address for reprints: Henry J. Malinowski, PhD, 15459 Arnold Palmer Dr, Haymarket, VA 20169; e-mail: h_malinowski{at}comcast.net.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?