What to look forward to in GaBI Journal, 2013, Issue 2
Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 2
Abstract
The first of two Letters to the Editor is from Ms Gaspani and Ms Milani expressing their concerns about the lack of clear regulatory guidelines for approval of liposomal generic formulations. Liposomal products are only one and perhaps some of the best-characterized example of non-biological complex drugs (NBCDs). NBCDs while not having a biological source can still be as or even more complex than many biologicals. New NBCDs are handled by some regulatory authorities as are generic drugs whose chemical structures can be completely characterized by their physico-chemical characteristics but this is not true for most NBCDs. In future issues of GaBI Journal we hope to publish many additional manuscripts concerning the testing and approval of both liposomal products as well as a number of other more complex NCBDs.
Authors and Affiliations
Philip D Walson
Keywords
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- EP ID EP354924
- DOI 10.5639/gabij.2013.0202.028
- Views 107
- Downloads 0
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