Same drug, different dosing: differences in dosing for drugs approved in the United States, Europe, and Japan.
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.
US Food and Drug Administration, Rochville, Maryland, USA. h_malinowski@comcast.net
Henry J
HJ
Malinowski
Agnes
A
Westelinck
Junko
J
Sato
Ting
T
Ong
D003625:Data Collection; D004358:Drug Therapy / Q000592:standards*; D005062:European Union; D005464:Fluorobenzenes / Q000008:administration & dosage; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage; D007564:Japan; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D011743:Pyrimidines / Q000008:administration & dosage; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000008:administration & dosage; D014481:United States
D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D004364:Pharmaceutical Preparations; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium