Recommendations On: Internal Standard Criteria, Stability, Incurred Sample Reanalysis and Recent 483s by the Global CRO Council for Bioanalysis

Lowes, Steve; Jersey, Jim; Shoup, Ronald E.; Garofolo, Fabio; Savoie, Natasha; Mortz, Ejvind; Needham, Shane; Caturla, Maria Cruz; Steffen, Ray; Sheldon, Curtis; Hayes, Roger N.; Samuels, T.; Donato, Lorella Di; Kamerud, John; Michael, Steve; Lin, Zhongping John; Hillier, Jim; Moussallie, Marc; Teixeira, Leonardo de Souza; Rocci, Mario L.; Buonarati, Mike; Truog, James; Hussain, Saleh; Lundberg, Richard; Breau, Alan P.; Zhang, Tianyi; Jonker, J.J.J.; Berger, Neil; Gagnon-Carignan, Sofi; Nehls, Corey; Nicholson, Robert Ian; Hilhorst, Martijn; Karnik, Shane; Boer, Theo de; Houghton, Richard; Smith, Kirk H.; Cojocaru, Laura; Allen, Mike; Harter, Tammy; Fatmi, Saadya; Sayyarpour, Farhad; Vija, Jenifer; Malone, Michele; Heller, Dennis

doi:10.4155/bio.11.135

Cited by 78 publications

(46 citation statements)

References 8 publications

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“…The chosen IS should resemble the analyte of interest during the sample preparation and analysis [28]. It should perfectly track the analyte and improves both accuracy and precision of the assay.…”

Section: Selection Of Internal Standardmentioning

confidence: 99%

Development of an LC–MS/MS method for simultaneous determination of memantine and donepezil in rat plasma and its application to pharmacokinetic study

Bhateria

Ramakrishna

Pakala

et al. 2015

Journal of Chromatography B

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Section: Selection Of Internal Standardmentioning

confidence: 99%

Development of an LC–MS/MS method for simultaneous determination of memantine and donepezil in rat plasma and its application to pharmacokinetic study

Bhateria

Ramakrishna

Pakala

et al. 2015

Journal of Chromatography B

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“…The Global CRO Council for bioana lysis [19] has started an ini tiative to collect CRO data already available or in progress on matrix stability for coformu lated and coadministered drugs. An article was published to that effect, providing preliminary results of a survey distributed to all Global CRO Council members and demonstrating the gen eral lack of an impact on stability caused by the presence of such drugs [20].…”

Section: Effect Of Anticoagulant Counterionsmentioning

confidence: 99%

2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and Inspections

Garofolo

Rocci²,

Dumont

et al. 2011

Bioanalysis

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The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for pharmaceutical companies, CROs and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon a consistent approach to recent issues in the bioanalysis of both small and large molecules. High quality, better compliance to regulations and scientific excellence are the foundation of this workshop. As in the previous editions of this significant event, recommendations were made and a consensus was reached among panelists and attendees, including industry leaders and regulatory experts representing the global bioanalytical community, on many 'hot' topics in bioanalysis. This 2011 White Paper is based on the conclusions from this workshop, and aims to provide a practical reference guide on those topics.

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“…More detailed information is available on its website [101]. QC; the use of a predefined criteria for samples employed for system conditioning and system suitability; the stability of compounds stated as light sensitive by suppliers; the approach for performing whole-blood stability; findings regarding IS variability; carryover and reporting of validation evaluations [12,[30][31][32][33][34]104]. An FDA untitled letter issued following FDA inspections of the bioanalytical facility of Cetero Research reporting dates/times falsifications, manipulation of samples and lack of documentation regarding system equilibration was discussed by Roger Hayes (Vice President and General Manager of Laboratory Sciences, MPI Research, USA).…”

Section: Appendix: 6th Wrib Conference Reportmentioning

confidence: 99%

2012 White Paper on Recent Issues in Bioanalysis And Alignment of Multiple Guidelines

DeSilva

Garofolo

Rocci³

et al. 2012

Bioanalysis

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Over 400 professionals representing pharmaceutical companies, CROs, and multiple regulatory agencies participated in the 6th Workshop on Recent Issues in Bioanalysis (WRIB). Like the previous sessions, this event was in the format of a practical, focused, highly interactive and informative workshop aiming for high-quality, improved regulatory compliance and scientific excellence. Numerous 'hot' topics in bioanalysis of both small and large molecules were shared and discussed, leading to consensus and recommendations among panelists and attendees representing the bioanalytical community. The major outcome of this year's workshop was the noticeable alignment of multiple bioanalytical guidance/guidelines from different regulatory agencies. This represents a concrete step forward in the global harmonization of bioanalytical activities. The present 2012 White Paper acts as a practical and useful reference document that provides key information and solutions on several topics and issues in the constantly evolving world of bioanalysis.

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Recommendations On: Internal Standard Criteria, Stability, Incurred Sample Reanalysis and Recent 483s by the Global CRO Council for Bioanalysis

Abstract: "The Global CRO Council (GCC) for Bioanalysis was formed in an effort to bring together many CRO leaders to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry"

Cited by 78 publications

References 8 publications

Development of an LC–MS/MS method for simultaneous determination of memantine and donepezil in rat plasma and its application to pharmacokinetic study

Development of an LC–MS/MS method for simultaneous determination of memantine and donepezil in rat plasma and its application to pharmacokinetic study

2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and Inspections

2012 White Paper on Recent Issues in Bioanalysis And Alignment of Multiple Guidelines

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