Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays

Viswanathan, C. T.; Bansal, Surendra K.; Booth, Brian; DeStefano, Anthony J.; Rose, Mark J.; Sailstad, Jeffrey; Shah, Vinod P.; Skelly, Jerome P.; Swann, Patrick G.; Weiner, Russell

doi:10.1208/aapsj0901004

Cited by 470 publications

(324 citation statements)

References 4 publications

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“…For decades, bioanalytical practitioners across the globe have relied upon the "Crystal City" (CC) white papers (1)(2)(3) and the FDA Guidance (4) for direction and standards on bioanalytical method validation (BMV) and sample analysis.…”

Section: Introductionmentioning

confidence: 99%

Repeat Analysis and Incurred Sample Reanalysis: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

Fluhler

Vazvaei²,

Singhal

et al. 2014

AAPS J

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Abstract. The A7 harmonization team (A7 HT), a part of the Global Bioanalysis Consortium (GBC), focused on reviewing best practices for repeat analysis and incurred sample reanalysis (ISR) as applied during regulated bioanalysis. With international representation from Europe, Latin America, North America, and the Asia Pacific region, the team first collated common practices and guidance recommendations and assessed their suitability from both a scientific and logistical perspective. Subsequently, team members developed best practice recommendations and refined them through discussions and presentations with industry experts at scientific meetings. This review summarizes the team findings and best practice recommendations. The few topics where no consensus could be reached are also discussed. The A7 HT recommendations, together with those from the other GBC teams, provide the basis for future international harmonization of regulated bioanalytical practices.

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Section: Introductionmentioning

confidence: 99%

Repeat Analysis and Incurred Sample Reanalysis: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

Fluhler

Vazvaei²,

Singhal

et al. 2014

AAPS J

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“…The 2001 US FDA bioanalytical method validation (BMV) [14] does not reference the need to provide or discuss rejected data. However, the Crystal City III conference report [15], a resource for industry providing additional information from regulators and industry representatives on BMV, expands on the topic and states that data from failed runs should be included in the validation report as part of a summary table of all validation runs analyzed, along with the reason for failure. Furthermore, "quality control (QC) data from validation runs that only failed to meet QC acceptance criteria with no assignable cause for failure should be included in the precision and accuracy estimation" and "although drug concentration data from the rejected runs need not be included in the final report, a brief description of the reasons and a tabular listing of rejected runs should be provided."…”

Section: Reporting Data From Failed Methods Validation Runsmentioning

confidence: 99%

The 10th GCC Closed Forum: Rejected Data, GCP in Bioanalysis, Extract Stability, BAV, Processed Batch Acceptance, Matrix Stability, Critical Reagents, Eln and Data Integrity and Counteracting Fraud

Cape¹,

Islam²,

Nehls³

et al. 2017

Bioanalysis

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The 10th Global CRO Council (GCC) Closed Forum was held in Orlando, FL, USA on 18 April 2016. In attendance were decision makers from international CRO member companies offering bioanalytical services. The objective of this meeting was for GCC members to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at this closed forum included reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, biomarker assay validation, processed batch acceptance criteria, electronic laboratory notebooks and data integrity, Health Canada's Notice regarding replicates in matrix stability evaluations, critical reagents and regulatory approaches to counteract fraud. In order to obtain the pharma perspectives on some of these topics, the first joint CRO–Pharma Scientific Interchange Meeting was held on 12 November 2016, in Denver, Colorado, USA. The five topics discussed at this Interchange meeting were reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, processed batch acceptance criteria and electronic laboratory notebooks and data integrity. The conclusions from the discussions of these topics at both meetings are included in this report.

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“…Sample storage stability should be performed under the similar conditions for the study sample measurement. The experiment should be conducted in unaltered representative matrix (20). Stability of protein biomarkers is also required to show that the assay is not compromised by pre-analytical factors, such as the variation in specimen collection and handling as well as the biological variation of the subjects to be tested.…”

Section: Selectivity and Parallelismmentioning

confidence: 99%

“Fit-for-Purpose” Method Validation and Application of a Biomarker (C-terminal Telopeptides of Type 1 Collagen) in Denosumab Clinical Studies

Wang

Lee

Burns

et al. 2009

AAPS J

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Abstract. Biomarkers are used to study drug effects, exposure-response relationships, and facilitate early decision making during development. Denosumab, a fully human monoclonal antibody against receptor activator of nuclear factor-κB ligand, profoundly inhibits bone resorption. C-terminal telopeptides of type I collagen (CTx), a bone resorption biomarker, provides early indications of denosumab effectiveness and informs protracted clinical outcomes (e.g., bone mineral density). Because of the dynamic relationship between denosumab and CTx, a precise and robust assay was desired. Thus, we adopted a fit-for-purpose approach to modify and validate a commercial CTx diagnostic kit to meet the intended applications of a quantitative pharmacodynamic biomarker for denosumab development. Seven standards were prepared to replace five calibrators provided in the kit. Three quality controls (QC) and two sample controls were used to characterize and monitor assay performance. Robotic workstations were used for standard and QC preparation and assay execution. Method validation experiments were conducted with rigor and procedures similar to those used for drug bioanalysis. The method demonstrated a linear range of 0.0490-2.34 ng/mL with four-parameter logistic regression. Inter-assay total error of validation samples in serum was ≤26.7%. Extensive tests were conducted on selectivity in sera from target populations, specificity, stability, parallelism, and dilutional linearity. Applications to samples from numerous clinical studies confirmed that the CTx method was reliable, robust, and fit for use as an early indicator of denosumab effectiveness. Refinement supported the confidence for use in pharmacokinetic/pharmacodynamic modeling, dose selections, correlation to clinical effects, and formulation bioequivalence work.KEY WORDS: bone resorption marker; commercial immunoassay kit; method validation; pharmacodynamic (PD) biomarker; serum C-terminal telopeptides of type 1 (CTx).

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Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays

Cited by 470 publications

References 4 publications

Repeat Analysis and Incurred Sample Reanalysis: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

Repeat Analysis and Incurred Sample Reanalysis: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

The 10th GCC Closed Forum: Rejected Data, GCP in Bioanalysis, Extract Stability, BAV, Processed Batch Acceptance, Matrix Stability, Critical Reagents, Eln and Data Integrity and Counteracting Fraud

“Fit-for-Purpose” Method Validation and Application of a Biomarker (C-terminal Telopeptides of Type 1 Collagen) in Denosumab Clinical Studies

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