Journal Article > CommentaryFull Text
Pathway to affordable quality assured sources of pegylated interferon alpha for treating hepatitis C
GaBI J. 2013 November 14; Volume 2; DOI:10.5639/gabij.2013.0204.053
Gaspani S, Milani B
GaBI J. 2013 November 14; Volume 2; DOI:10.5639/gabij.2013.0204.053
Journal Article > LetterFull Text
GaBI J. 2013 May 13; Volume 2 (Issue 2); DOI:10.5639/gabij.2013.0202.022
Gaspani S, Milani B
GaBI J. 2013 May 13; Volume 2 (Issue 2); DOI:10.5639/gabij.2013.0202.022
The lack of clear regulatory guidance remains a key bottleneck for securing a second quality-assured source of liposomal amphotericin B (LAmB), the WHO-recommended drug for visceral leishmaniasis. The approval of the first generic liposomal product by the US Food and Drug Administration in February 2013 could be a turning point, and serve as a basis for WHO to develop guidance for the evaluation of generic liposomal formulations.