Sangster T.,Charles River Associates |
Maltas J.,BASi |
Struwe P.,Celerion |
Hillier J.,Gen-Probe |
And 27 more authors.
Bioanalysis | Year: 2012
The 5th Global CRO Council for Bioanalysis (GCC) meeting, held in Barcelona, Spain, in November 2011, provided a unique opportunity for CRO leaders to openly share opinions, perspectives and to agree on bioanalytical recommendations on incurred sample reproducibility in multi-analyte assays, regulation of quality assurance/bioanalytical consultants and regulatory requirements for GCP. © 2012 Future Science Ltd.
Lowes S.,Quintiles |
Boterman M.,ABL |
Doig M.,ABS Laboratories |
Breda M.,Accelera |
And 88 more authors.
Bioanalysis | Year: 2012
An open letter written by the Global CRO Council for Bioanalysis (GCC) describing the GCC survey results on stability data from co-administered and co-formulated drugs was sent to multiple regulatory authorities on 14 December 2011. This letter and further discussions at different GCC meetings led to subsequent recommendations on this topic of widespread interest within the bioanalytical community over the past 2 years. © 2012 Future Science Ltd.
Agency: European Commission | Branch: FP7 | Program: BSG-SME | Phase: SME-1 | Award Amount: 1.42M | Year: 2009
The project will focus on the pre-clinical development of carbon monoxide releasing molecules (CORMs) for the treatment of rheumatoid arthritis (RA). Carbon monoxide (CO) has been shown, by several renowned laboratories around the world, to have a number of anti-inflammatory properties which turn it into an exceptionally promising compound against chronic inflammatory diseases such as RA. In its gaseous form CO will hardly be applicable as a drug in a clinical setting. One proponent SME, has conceived and produced a large number of molecules which will release or donate CO, inside the organism, in specific physiological or pathological conditions. These molecules, called CORMs, hold the promise of delivering CO in controlled amounts, at specific rates and in a targeted manner to inflamed tissues such as arthritic joints. In recent months some of these CORMs have been tested in preliminary experiments using rodent models of RA, and have yielded encouraging results in terms of efficacy and toxicity. The main goal of this project will be: to select a small number of exceptionally promising CORMs for the treatment of RA, to develop the best formulations for those compounds, to test their detailed pharmacological and toxicological properties, and ultimately arrive at one lead candidate for clinical development. With this aim, three different SMEs will join their resources, critical mass and knowledge in the field of CORMs, pharmacological test, analysis and standardization and validation of developed assays to gain the ambitious, but reasonable goal: at least one new molecule in clinical trials.
Ingelse B.,Merck And Co. |
Ingelse B.,Quintiles |
Barroso B.,Astellas Pharma Europe |
Gray N.,Covance |
And 6 more authors.
Bioanalysis | Year: 2014
Recent guidelines on bioanalytical method validation have recommended to investigate matrix effects in special matrices such as hemolytic and hyperlipidemic plasma. However, these guidelines were not clear on how to implement these recommendations. The European Bioanalysis Forum has discussed this topic in depth and has asked for feedback from member companies. Those discussions have resulted in more specific guidance on how to define hemolytic and hyperlipidemic plasma, how to validate bioanalytical methods for these matrices and how to deal with hemolytic and hyperlipidemic study samples. These recommendations are presented in this manuscript. © 2014 Future Science Ltd.
Enzler M.,Swiss BioQuant AG |
Schipp S.,Swiss BioQuant AG |
Nicolas L.B.,Actelion Pharmaceuticals |
Dingemanse J.,Actelion Pharmaceuticals |
Siethoff C.,Swiss BioQuant AG
Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences | Year: 2012
An HPLC-MS/MS method was developed and validated for the quantification of 6-keto prostaglandin F1α, the stable hydrolysis product of prostacyclin, and its metabolites 2,3-dinor-6-keto prostaglandin F1α and 6,15-diketo-13,14-dihydro prostaglandin F1α in human plasma. For sample preparation, a solid phase extraction step was combined with a column switching approach for analytes enrichment and further sample clean-up of the processed sample. The assay was validated in the concentration range 50.0-5000. pg/mL for 6-keto prostaglandin F1α and 6,15-diketo-13,14-dihydro prostaglandin F1α, and 100-10,000. pg/mL for 2,3-dinor-6-keto prostaglandin F1α. The inter-batch precision was better than 12.7%, 9.2%, and 9.4% for 6-keto prostaglandin F1α, 2,3-dinor-6-keto prostaglandin F1α, and 6,15-diketo-13,14-dihydro prostaglandin F1α, respectively. The inter-batch accuracy was between 97.3% and 100.8% for 6-keto prostaglandin F1α, between 97.5% and 103.0% for 2,3-dinor-6-keto prostaglandin F1α, and between 92.0% and 100.0% for 6,15-diketo-13,14-dihydro prostaglandin F1α. Further it has been demonstrated that the analytes were stable in plasma for 20. h at room temperature, during three freeze-and-thaw cycles, for 96 days at -25°C storage temperature, and 50. h in the autosampler tray at room temperature. © 2012 Elsevier B.V.
PubMed | Swiss BioQuant AG
Type: | Journal: Journal of chromatography. B, Analytical technologies in the biomedical and life sciences | Year: 2012
An HPLC-MS/MS method was developed and validated for the quantification of 6-keto prostaglandin F1, the stable hydrolysis product of prostacyclin, and its metabolites 2,3-dinor-6-keto prostaglandin F1 and 6,15-diketo-13,14-dihydro prostaglandin F1 in human plasma. For sample preparation, a solid phase extraction step was combined with a column switching approach for analytes enrichment and further sample clean-up of the processed sample. The assay was validated in the concentration range 50.0-5000 pg/mL for 6-keto prostaglandin F1 and 6,15-diketo-13,14-dihydro prostaglandin F1, and 100-10,000 pg/mL for 2,3-dinor-6-keto prostaglandin F1. The inter-batch precision was better than 12.7%, 9.2%, and 9.4% for 6-keto prostaglandin F1, 2,3-dinor-6-keto prostaglandin F1, and 6,15-diketo-13,14-dihydro prostaglandin F1, respectively. The inter-batch accuracy was between 97.3% and 100.8% for 6-keto prostaglandin F1, between 97.5% and 103.0% for 2,3-dinor-6-keto prostaglandin F1, and between 92.0% and 100.0% for 6,15-diketo-13,14-dihydro prostaglandin F1. Further it has been demonstrated that the analytes were stable in plasma for 20 h at room temperature, during three freeze-and-thaw cycles, for 96 days at -25 C storage temperature, and 50h in the autosampler tray at room temperature.