C. A. James
Pharmacia
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Publication
Featured researches published by C. A. James.
Journal of Pharmaceutical and Biomedical Analysis | 2003
G. Basileo; Massimo Breda; G. Fonte; R. Pisano; C. A. James
This paper describes a high-throughput sample preparation procedure combined with LC-MS/MS analysis to measure paclitaxel in human plasma. Paclitaxel and an internal standard were extracted from plasma by a semi-automated robotic method using liquid-liquid extraction. Thereafter compounds were separated on a RP C18 column. Detection was by a PE Sciex API 3000 mass spectrometer equipped with a TurboIonSpray interface. The compounds were detected in positive ion mode using the mass transition m/z 854.6-->286.2 and m/z 831.6-->263.2 for paclitaxel and the internal standard, respectively. The limit of quantitation for paclitaxel was 1 ng/ml with an imprecision of 5.2% following extraction of 0.1 ml of plasma. Linearity was confirmed over the whole calibration range (1-1000 ng/ml) with correlation coefficients higher than 0.99 indicating good fits of the regression models. The inter and intra-day precision was better than 9.5% and the accuracy ranged from 90.3 to 104.4%. The assay was simple, fast, specific and exhibited excellent ruggedness.
Journal of Pharmaceutical and Biomedical Analysis | 2003
Sara Calderoli; Emiliana Colombo; Enrico Frigerio; C. A. James; Martin Sibum
LC-MS-MS method using automated on-line solid-phase extraction (SPE) has been developed and validated for the quantitation of brostallicin (I), a new distamycin derivative, in human plasma. I is a DNA minor groove binder currently under phase I-II clinical evaluation as an anticancer drug. Plasma (0.4 ml) was spiked with 0.2 ml stable label IS solution and placed in a 96-well plate maintained at +4 degrees C. Aliquots of 0.1 ml of prepared samples were loaded into the on-line SPE HySphere Resin SH cartridges (10 mm x 2 mm ID) and the analytes back eluted with the mobile phase into LC-MS-MS system. A Platinum Cyano column (100 mm x 4.6 mm, 3.6 microm) was used to perform the chromatographic analysis. The mobile phase was acetonitrile-ammonium formate buffer (pH 3.5; 20 mM) (70:30, v/v) at a flow rate of 1.0 ml/min. LC flow was split so that 300 microl/min was directed toward the mass spectrometer interface. Retention time of I was 2.6 min and the total cycle time was 8 min. MS detection used an Applied Biosystems/MDS SCIEX API 365 with a TurboIonSpray interface and MRM (m/Z: 725/257 for I and m/Z: 729/257 for IS) operated in positive ion mode. The method was validated over the calibration range 0.124-497 ng/ml. A negligible carry-over effect from the system was observed. In spite of the known instability of I in human plasma (about 20% decrease over 12 h), the ratio analyte/IS peak area showed good stability over the analysis time required for 96 samples. The automated on-line SPE method can be considered as a valid alternative to the off-line manual SPE procedure previously developed.
Chromatographia | 2002
J. M. Long; C. A. James; Brian J. Clark; M. G. Castelli; S. Rolando
SummaryThe bioavailability of a novel anticancer drug has been estimated in a cannulated mouse model, in which full pharmacokinetic profiles were obtained from a single animal. After with-drawing serial blood samples from the animal, small volumes of the plasma were prepared and analysed by the direct on-line injection of plasma into a turbulent flow chromatography extraction system linked to mass spectrometric detection. The use of these techniques significantly reduced both the number of animals needed to perform the experiment and the amount of active drug synthesised for administration whilst still maintaining adequate sensitivity to provide suitable pharmacokinetic profiles.
Bioanalysis | 2016
Eric Yang; Jan Welink; Stephanie Cape; E.J. Woolf; Jens Sydor; C. A. James; Dina Goykhman; Mark E. Arnold; Neil Addock; Ronald Bauer; Michael Buonarati; Eugene Ciccimaro; Raj Dodda; Christopher Evans; Fabio Garofolo; Nicola Hughes; Rafiq Islam; Corey Nehls; Amanda Wilson; Chad Briscoe; Mark Bustard; Laura Coppola; Stephanie Croft; Dieter M. Drexler; Luca Ferrari; Daniela Fraier; Rand Jenkins; John Kadavil; Lloyd King; Wenkui Li
The 2016 10th Workshop on Recent Issues in Bioanalysis (10th WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - A Full Immersion Week of Bioanalysis including Biomarkers and Immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecule analysis involving LCMS, hybrid LBA/LCMS, and LBA approaches, with the focus on biomarkers and immunogenicity. This 2016 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. This white paper is published in 3 parts due to length. This part (Part 1) discusses the recommendations for small molecules, peptides and small molecule biomarkers by LCMS. Part 2 (Hybrid LBA/LCMS and regulatory inputs from major global health authorities) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will be published in the Bioanalysis journal, issue 23.
Chromatographia | 2002
C. A. James; M. Breda; E. Frigerio; J. Long; K. Munesada
SummaryFast turnaround bioanalysis can significantly improve decision making within the drug discovery and development process. Such analyses can generally be efficiently achieved by application of appropriate strategies and use of modern analytical instruments and techniques. A rethink of some bioanalytical processes will be required if all demands for rapid analyses are to be met in future.
Chromatographia | 2002
C. A. James; M. Breda; E. Frigerio; J. Long; K. Munesada
SummaryDue to the life-threatening nature of cancer as a disease, treatment strategies are undertaken which would not be acceptable in other therapeutic classes. Bioanalytical problems can be related directly to the characteristics of certain oncology drugs in cluding their mechanism of action, use of novel intravenous formulations, attempts at tumour targeting, and drug carrier systems. Increasing challenges may also be presented by the need to analyze for a wide range of biomarker molecules.
Journal of Pharmaceutical and Biomedical Analysis | 2005
Patrice J. Larger; Massimo Breda; Daniela Fraier; Heather Hughes; C. A. James
Journal of Pharmaceutical and Biomedical Analysis | 2005
Rossella Pisano; Massimo Breda; Simona Grassi; C. A. James
Cancer Chemotherapy and Pharmacology | 2003
Nenad Sarapa; Margaret Britto; William Speed; MariaGabriella Jannuzzo; Massimo Breda; C. A. James; MariaGrazia Porro; Maurizio Rocchetti; Alkvin Wanders; Haile Mahteme; Peter Nygren
Journal of Pharmaceutical and Biomedical Analysis | 2002
D Fraier; E. Frigerio; G Brianceschi; C. A. James