2009 White Paper on Recent Issues in Regulated Bioanalysis from The 3rd Calibration and Validation Group Workshop

Savoie, Natasha; Garofolo, Fabio; Amsterdam, Peter van; Booth, Brian; Fast, Douglas M.; Lindsay, Michael; Lowes, Steve; Massé, Robert; Mawer, Louise; Ormsby, Eric; Phull, Rupinder; Rocci, Mario L.; Vallano, Patrick T.; Yin, Xiaobin

doi:10.4155/bio.09.134

Cited by 83 publications

(54 citation statements)

References 8 publications

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“…It was stated at that time, however, that the anticoagulant used in the study protocol should be consistent with the validation, otherwise additional testing should be done [3]. Following 2 years of testing the impact of anticoagulant counterions by industry, it was concluded in 2011 that no significant impact had been observed.…”

Section: Anticoagulant Counterionsmentioning

confidence: 99%

“…Discussions continued in 2008, where it was confirmed that ISR was being successfully implemented within the industry, although there were still clarifications needed regarding the amount of samples necessary and the final criteria to be used [2]. The following year, consensus stipulated that the number of samples to be re-assayed for the ISR evaluation should be between 5% and 10%, based on the attendees' experiences in LCMS [3]. The recommendation was extended to LBAs in 2010, with the additional statement that the same dilution factor as the original analysis is not required as long as supporting parallelism data exist, but is usually selected in practice [4].…”

Section: Incurred Sample Reanalysismentioning

confidence: 99%

“…However, good scientific judgment must be used in the cases where a change is required and changes must be documented with management approval. Manually modified chromatograms are not generally reported in the final report but they may be reported if desired [3]. In 2011, the recommendation was clarified for cases when manual modifications were judged necessary; they may be performed with scientific justification, before the results are regressed and documented in a controlled fashion [5].…”

Section: Chromatogram Integrationmentioning

confidence: 99%

“…Following continued discussions in 2009, 2010 and 2011, it was recommended to at least investigate the impact of hemolysis during method development since agency trends demonstrate that this evaluation is requested [3,4,5]. In 2011, it was also stated that the prevalence of hemolyzed samples during sample analysis should be taken into account [5].…”

Section: Hemolysis Testing (Lcms)mentioning

confidence: 99%

“…The signal can be saturated resulting in unacceptable chromatography and suppression or enhancement of matrix effects. The need and method to perform tests to validate a range of injection volumes during method validation was discussed in 2009 [3].…”

Section: Injection Volumesmentioning

confidence: 99%

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The Decennial Index of The White Papers in Bioanalysis: ‘A Decade of Recommendations (2007–2016)’

Garofolo¹,

Savoie²

2017

Bioanalysis

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Each year, the Workshop on Recent Issues in Bioanalysis (WRIB) gathers a wide range of industry opinion leaders and regulatory authorities working on bioanalysis, biomarkers and immunogenicity to discuss the most current topics of interest, and to provide potential solutions aiming to improve quality, increase regulatory compliance and achieve scientific excellence.These yearly 'hot' topics (covering both small and large molecules), are the starting point for fruitful exchanges of knowledge, and extensive sharing of ideas among presenters, regulators and attendees, and are distilled into a series of relevant recommendations. The resultant White Papers summarizing these conclusions and consensus points from each WRIB provide the global bioanalytical community with key information and practical solutions on topics and issues addressed each year. This series of White Papers has always been among the 'most read' articles in Bioanalysis over the past 10 years [17].WRIB White Papers are designed to be 'horizontal' documents providing consensus on multiple topics rather than 'vertical' (i.e., 'consensus documents on a single topic for standardizing industry practice'). It is a cumulative effort spanning more than a year, with tremendous work behind the scenes by each co-author, starting from exhaustive preparation/design of each issue long before the WRIB, then extensive working-dinner discussions to prepare open panel discussions at the WRIB, and finally the refinement and critical review of the draft recommendations before turning it into a consensus paper.In recent years, to reflect the new structure of three sequential, core workshop days at WRIB, each White Paper has been divided into three parts to reflect the focus of each core workshop day: Part 1 on LCMS, Part 2 on hybrid ligand-binding assays (LBA)/LCMS and Regulatory Inputs and Part 3 on LBA.Although the recommendations presented in this article demonstrate that some topics have been extensively discussed repeatedly in the last decade, the evolution of bioanalysis, biomarkers and immunogenicity, and the accompanying technologies and regulations continue to bring additional challenges and solutions to existing problems. Continued assembly of industry and regulators will ensure that best practices continue in order to market safe and effective pharmaceutical products. The future publication of the 2017 White Paper in Bioanalysis signals the global bioanalytical community's intent to continue providing a consensus document for such discussions.After a decade of discussions and consensus, this article acts as a general index, organized by topic in alphabetic order, to easily consult all these recommendations and their evolution over time.

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Section: Anticoagulant Counterionsmentioning

confidence: 99%

Section: Incurred Sample Reanalysismentioning

confidence: 99%

Section: Chromatogram Integrationmentioning

confidence: 99%

Section: Hemolysis Testing (Lcms)mentioning

confidence: 99%

Section: Injection Volumesmentioning

confidence: 99%

See 3 more Smart Citations

The Decennial Index of The White Papers in Bioanalysis: ‘A Decade of Recommendations (2007–2016)’

Garofolo¹,

Savoie²

2017

Bioanalysis

Self Cite

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Analytical Method Development and Validation in Accordance to the Regulatory Guidelines

Unger

2012

Encyclopedia of Drug Metabolism and Interactions

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Best practices and detailed requirements to perform LCMS bioanalysis for submission to regulatory agencies are defined in this chapter. The rationale for regulations is discussed, along with recommendations on achieving compliance. Novel drug candidates, new technology, and innovative processes continue to change LCMS bioanalysis. The evolution of global regulatory guidance is also shaping bioanalysis to test assays in a more consistent and thorough manner. Common procedures are now in place for validation and sample analysis of both large and small molecules, allowing consistent review of new drug applications. Influence from GMPs is seen in incurred sample reanalysis and associated out‐of‐specification investigations in bioanalysis. The nature of regulated bioanalysis is ever changing as new methodology and guidance challenges past practices.

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Regulatory Inspection Trends and Findings of Bioanalytical Laboratories

Chow¹,

Yau²,

Lachman³

2013

Handbook of LC‐MS Bioanalysis

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2009 White Paper on Recent Issues in Regulated Bioanalysis from The 3rd Calibration and Validation Group Workshop

Cited by 83 publications

References 8 publications

The Decennial Index of The White Papers in Bioanalysis: ‘A Decade of Recommendations (2007–2016)’

The Decennial Index of The White Papers in Bioanalysis: ‘A Decade of Recommendations (2007–2016)’

Analytical Method Development and Validation in Accordance to the Regulatory Guidelines

Regulatory Inspection Trends and Findings of Bioanalytical Laboratories

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