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Recommendations on biomarker bioanalytical method validation by GCC.
The 5th GCC in Barcelona (Spain) and 6th GCC in San Antonio (TX, USA) events provided a unique opportunity for CRO leaders to openly share opinions and perspectives, and to agree upon recommendationsExpand
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Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).
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 regulatoryExpand
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Simultaneous quantitation of polymyxin B1, polymyxin B2 and polymyxin B1-1 in human plasma and treated human urine using solid phase extraction and liquid chromatography-tandem mass spectrometry.
Two liquid chromatographic-tandem mass spectrometric (LC-MS/MS) methods have been developed and validated for the quantitative determination of polymyxin B1, polymyxin B2 and polymyxin B1-1Expand
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Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars.
The 6th Global CRO Council for Bioanalysis (GCC) Closed Forum was held on 27 March 2012 in San Antonio, TX, USA, the day before the start of the 6th Workshop on Recent Issues in Bioanalysis. TheExpand
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Recommendations on incurred sample stability (ISS) by GCC.
The topic of incurred sample stability (ISS) has generated considerable discussion within the bioanalytical community in recent years. The subject was an integral part of the seventh annual WorkshopExpand
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A systematic approach for developing a robust LC-MS/MS method for bioanalysis.
In order to meet the drug discovery and development needs of pharmaceutical companies, CROs are constantly challenged by the requirements for rapid LC-MS/MS method development prior to methodExpand
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Identifying trends and developing solutions for incurred sample reanalysis failure investigations in a bioanalytical CRO.
In 2007, the US FDA recommended that pharmaceutical companies and CROs conduct incurred sample reanalysis (ISR) following the analysis of study samples using validated methods. Between January 2008Expand
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8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.
The 8th GCC Closed Forum for Bioanalysis was held in Baltimore, MD, USA on 5 December 2013, immediately following the 2013 AAPS Workshop (Crystal City V): Quantitative Bioanalytical MethodsExpand
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Small Molecule Specific Run Acceptance, Specific Assay Operation, and Chromatographic Run Quality Assessment: Recommendation for Best Practices and Harmonization from the Global Bioanalysis
Consensus practices and regulatory guidance for liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) assays of small molecules are more aligned globally than for any of the otherExpand
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Method development and validation of six bile acids for regulated bioanalysis: improving selectivity and sensitivity.
BACKGROUND Quantification of bile acids using LC-MS has previously been very challenging on triple quadrupole MS systems due to the absence of a primary fragment ion for unconjugated bile acids. Expand
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