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Ingelse B.,Merck And Co. | Ingelse B.,Quintiles | Gray N.,Covance | Jakob-Rodamer V.,CRS Clinical Research Services Mannheim | And 5 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.

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 86 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.

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.

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