| Literature DB >> 16806858 |
E Gupta1, D M Barends, E Yamashita, K A Lentz, A M Harmsze, V P Shah, J B Dressman, R A Lipper.
Abstract
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.Mesh：
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Year: 2006 PMID： 16806858 DOI： 10.1016/j.ejps.2006.05.001
Source DB: PubMed Journal: Eur J Pharm Sci ISSN： 0928-0987 Impact factor: 4.384