The 2nd Calibration and Validation Group Workshop on Recent Issues in Good Laboratory Practice Bioanalysis

Savoie, Natasha; Booth, Brian; Bradley, T Hyman; Garofolo, Fabio; Hughes, Nicola; Hussain, Saleh; King, Shang‐Ying P.; Lindsay, Michael; Lowes, Steve; Ormsby, Eric; Phull, Rupinder; Rocci, Mario L.; Vallano, Patrick T.; Viau, Alan; Zhu, Zhigang

doi:10.4155/bio.09.11

Cited by 87 publications

(37 citation statements)

References 8 publications

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“…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].…”

Section: Incurred Sample Reanalysismentioning

confidence: 99%

“…In 2008, consensus was reached that the evaluation of hemolysis effects was required [2]. 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].…”

Section: Hemolysis Testing (Lcms)mentioning

confidence: 99%

“…In 2008, the acceptance of nonlinear calibration models and how much quadracity is acceptable were discussed [2]. A second look at the topic in 2015 resulted in the recommendation that the selection of the regression model should be step-by-step, beginning with a simple model (linear) and then moving to more complex models (quadratic), each testing the model improvement through the use of weighting, supported by a predefined statistical approach and documented as part of company SOPs [11].…”

Section: Calibration Curve: Regression Modelmentioning

confidence: 99%

“…It was clarified in 2008 that autosampler stability and reinjection reproducibility are two different evaluations that test stability during different parts of samples analysis. Depending on how routine sample analysis is conducted in a bioanalytical laboratory, it may be necessary to perform one or both evaluations during method validation [2]. Best practice for extract stability dictates that stored low and high QC samples should be measured against a fresh calibration curve, and analyte/IS ratio should be used [14].…”

Section: Autosampler Stability and Reinjection Reproducibilitymentioning

confidence: 99%

“…When selecting a regression type, guidance documents state that the simplest model should be used [2]. In 2008, the acceptance of nonlinear calibration models and how much quadracity is acceptable were discussed [2].…”

Section: Calibration Curve: Regression Modelmentioning

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: Incurred Sample Reanalysismentioning

confidence: 99%