Review of global regulations concerning biowaivers for immediate release solid oral dosage forms.
The regulations with respect to biowaivers for immediate release (IR) solid oral dosage forms in the USA, the EU, Japan and from the World Health Organization (WHO) are summarized and compared. Two case studies are presented, one from our own files and one from the open literature, showing the similarities and the differences among the qualification requirements of the four systems. The regulatory experience gained up to now is reviewed and expected future trends are discussed.
Gupta
E
E
Bristol-Myers Squibb Pharmaceutical Research Institute, Princeton, NJ, USA.
Barends
D M
DM
Yamashita
E
E
Lentz
K A
KA
Harmsze
A M
AM
Shah
V P
VP
Dressman
J B
JB
Lipper
R A
RA
D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical; D004304:Dosage Forms; D004335:Drug and Narcotic Control; D012995:Solubility; D014481:United States; D014486:United States Food and Drug Administration; D014944:World Health Organization
D004304:Dosage Forms