A new issue of this journal has just been published. To see abstracts of the papers it contains (with links through to the full papers) click here:
Selected papers from this issue:Transfer of analytical procedures: a panel of strategies selected for risk management, with emphasis on an integrated equivalence-based comparative testing approach
02 June 2011, 21:16:53
Publication year: 2011
Source: Journal of Pharmaceutical and Biomedical Analysis, In Press, Accepted Manuscript, Available online 2 June 2011
C., Agut , A., Caron , C., Giordano , D., Hoffman , A., Ségalini
In 2001, a multidisciplinary team made of analytical scientists and statisticians at sanofi-aventis has published a methodology which has governed, from that time, the transfers from R&D sites to Manufacturing sites of the release monographs. This article provides an overview of the recent adaptations brought to this original methodology taking advantage of our experience and the new regulatory framework, and, in particular, the risk management perspective introduced by ICH Q9. Although some alternate strategies have been introduced in our practices, the comparative testing one, based equivalence testing as statistical approach, remains the standard for assays lying on very critical quality...
Source: Journal of Pharmaceutical and Biomedical Analysis, In Press, Accepted Manuscript, Available online 2 June 2011
C., Agut , A., Caron , C., Giordano , D., Hoffman , A., Ségalini
In 2001, a multidisciplinary team made of analytical scientists and statisticians at sanofi-aventis has published a methodology which has governed, from that time, the transfers from R&D sites to Manufacturing sites of the release monographs. This article provides an overview of the recent adaptations brought to this original methodology taking advantage of our experience and the new regulatory framework, and, in particular, the risk management perspective introduced by ICH Q9. Although some alternate strategies have been introduced in our practices, the comparative testing one, based equivalence testing as statistical approach, remains the standard for assays lying on very critical quality...
Isolation, identification and antiviral activities of metabolites of calycosin-7-O-β-D-glucopyranoside
01 June 2011, 21:26:45
Publication year: 2011
Source: Journal of Pharmaceutical and Biomedical Analysis, In Press, Accepted Manuscript, Available online 1 June 2011
Luying, Chen , Zhixiong, Li , Yihong, Tang , Xiaolan, Cui , Ronghua, Luo , ...
In vivo and in vitro metabolites of calycosin-7-O-β-D-glucopyranoside in rats were identified using a specific and sensitive high performance liquid chromatography-tandem mass spectrometry (HPLC-MSn) method. The parent compound and twelve metabolites were found in rat urine after oral administration of calycosin-7-O-β-D-glucopyranoside. The parent compound and six metabolites were detected in rat plasma. In heart, liver, spleen, lung and kidney samples respectively, six, eight, seven, nine and nine metabolites were identified, in addition to the parent compound. Three metabolites, but no trace of parent drug, were found in the rat intestinal flora incubation mixture and feces, which demonstrated cleavage of the...
Source: Journal of Pharmaceutical and Biomedical Analysis, In Press, Accepted Manuscript, Available online 1 June 2011
Luying, Chen , Zhixiong, Li , Yihong, Tang , Xiaolan, Cui , Ronghua, Luo , ...
In vivo and in vitro metabolites of calycosin-7-O-β-D-glucopyranoside in rats were identified using a specific and sensitive high performance liquid chromatography-tandem mass spectrometry (HPLC-MSn) method. The parent compound and twelve metabolites were found in rat urine after oral administration of calycosin-7-O-β-D-glucopyranoside. The parent compound and six metabolites were detected in rat plasma. In heart, liver, spleen, lung and kidney samples respectively, six, eight, seven, nine and nine metabolites were identified, in addition to the parent compound. Three metabolites, but no trace of parent drug, were found in the rat intestinal flora incubation mixture and feces, which demonstrated cleavage of the...
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