Erschienen in:
01.10.2006 | Abstracts
ABSTRACTS: ISoP Annual Conference ‘Joining Forces for Managing Risks’ Liège, Belgium 11–13 October, 2006
verfasst von:
M. Hauben, L. Reich, M. Younus
Erschienen in:
Drug Safety
|
Ausgabe 10/2006
Einloggen, um Zugang zu erhalten
Excerpt
Background: Pfizer has recently presented as part of an effective life cycle risk management strategy for a product, a review of spontaneous reports of hepatic dysfunction with pegvisomant, a PEGylated compound used to treat acrogmegaly. There is no non-PEGylated version of this compound commercially available. In general, non-PEGylated versions of marketed PEGylated drugs have been commercially available earlier than their PEGylated counterparts. Data mining algorithms (DMAs) are currently being applied to spontaneous reporting system (SRS) databases as part of a multidisciplinary approach to drug safety to provide quantitative data to supplement case-level clinical review. …