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

Garofolo, Fabio; Rocci, Mario L.; Dumont, Isabelle; Martinez, Suzanne; Lowes, Steve; Woolf, Eric; Amsterdam, Peter van; Bansal, Surendra K.; Barra, Ariadna Cristina Gomes; Bauer, Ronald S.; Booth, Brian; Carrasco‐Triguero, Montserrat; DeSilva, Binodh; Dunn, John A.; Gallicano, Keith; Gouty, Dominique; Ho, Stacy; Hucker, Richard; Jemal, Mohammed; Katori, Noriko; Blaye, Olivier Le; Lee, Jean; Li, Wenkui; Michael, Steve; Nehls, Corey; Nicholson, Robert Ian; Ormsby, Eric; Tang, Daniel; Viswanathan, C. T.; Weiner, Russell; Young, Graeme

doi:10.4155/bio.11.192

Cited by 85 publications

(56 citation statements)

References 14 publications

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“…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]. Still, further clarifications were requested in 2016 in order to better define a manual modification.…”

Section: Chromatogram Integrationmentioning

confidence: 99%

“…Following 2 years of testing the impact of anticoagulant counterions by industry, it was concluded in 2011 that no significant impact had been observed. This could be verified during method development via benchtop stability testing with the different anticoagulant counterions of interest [5].…”

Section: Anticoagulant Counterionsmentioning

confidence: 99%

“…However, the recommendation in 2011 states that although different calibration curve slopes may be obtained between different LCMS systems, a coefficient of variation of ≤15% in slope values within injection systems suggests that the robustness of the method is not affected [5]. This was expanded in 2015 to add that unexplained, extreme variations should be evaluated to assess impact on accuracy [11].…”

Section: Calibration Curve: Slopementioning

confidence: 99%

“…However, when performing stability evaluations, a 'fresh' curve preparation means freshly fortified calibration standards only, while QC samples may not need to be freshly f ortified since subject samples are generally frozen at least once and thawed [5].…”

Section: Calibration Curvesmentioning

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: Chromatogram Integrationmentioning

confidence: 99%

Section: Anticoagulant Counterionsmentioning

confidence: 99%

Section: Calibration Curve: Slopementioning

confidence: 99%

Section: Calibration Curvesmentioning

confidence: 99%

See 2 more Smart Citations

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

Garofolo¹,

Savoie²

2017

Bioanalysis

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“…Some regulators, for example, in Europe and Brazil, are recommending the evaluation of matrix factor in hemolyzed plasma in their bioanalytical assay validation guidelines (17,18). Analyses of hemolyzed study samples have been much discussed in the bioanalytical field, with a focus on matrix effect, analyte stability in hemolyzed plasma, and Breportability^of the bioanalytical results (19)(20)(21)(22). Bioanalytical laboratories in general conduct formal evaluation of matrix factor, specificity/selectivity in hemolyzed plasma during method validation, usually at a pre-defined level of hemolysis, for example, plasma spiked with hemolyzed blood to a final percentage of 2% (19).…”

Section: Introductionmentioning

confidence: 99%

Utilizing Internal Standard Responses to Assess Risk on Reporting Bioanalytical Results from Hemolyzed Samples

Fung

Aubry

Allentoff

et al. 2015

AAPS J

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Abstract. Bioanalytical analysis of toxicokinetic and pharmacokinetic samples is an integral part of small molecule drugs development and liquid chromatography-tandem mass spectrometry (LC-MS/MS) has been the technique of choice. One important consideration is the matrix effect, in which ionization of the analytes of interest is affected by the presence of co-eluting interfering components present in the sample matrix. Hemolysis, which results in additional endogenous components being released from the lysed red blood cells, may cause additional matrix interferences. The effects of the degree of hemolysis on the accuracy and precision of the method and the reported sample concentrations from hemolyzed study samples have drawn increasing attention in recent years, especially in cases where the sample concentrations are critical for pharmacokinetic calculation. Currently, there is no established procedure to objectively assess the risk of reporting potentially inaccurate bioanalytical results from hemolyzed study samples. In this work, we evaluated the effect of different degrees of hemolysis on the internal standard peak area, accuracy, and precision of the analyses of BMS-906024 and its metabolite, BMS-911557, in human plasma by LC-MS/MS. In addition, we proposed the strategy of using the peak area of the stable isotope-labeled internal standard (SIL-IS) from the LC-MS/MS measurement as the surrogate marker for risk assessment. Samples with peak areas outside of the pre-defined acceptance criteria, e.g., less than 50% or more than 150% of the average IS response in study samples, plasma standards, and QC samples when SIL-IS is used, are flagged out for further investigation.KEY WORDS: hemolyzed sample/haemolyzed sample; hyperlipemic sample; internal standard peak area/internal standard responses; LC-MS/MS; regulated bioanalysis; risk assessment.

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Model‐Independent and Model‐Based Methods to Assess Drug–Drug Interactions for Therapeutic Proteins

Barrett

2013

Pharmaceutical Sciences Encyclopedia

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

Cited by 85 publications

References 14 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)’

Utilizing Internal Standard Responses to Assess Risk on Reporting Bioanalytical Results from Hemolyzed Samples

Model‐Independent and Model‐Based Methods to Assess Drug–Drug Interactions for Therapeutic Proteins

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