Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples.
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Stability: recommendation for best practices and harmonization from the Global Bioanalysis Consortium Harmonization TeamA white paper--consensus and recommendations of a global harmonization team on assessing the impact of immunogenicity on pharmacokinetic measurements.Critical topics in ensuring data quality in bioanalytical LC-MS method development.Issues on fit-for-purpose validation of a panel of ELISAs for application as biomarkers in clinical trials of anti-Angiogenic drugs.An integrated bioanalytical method development and validation approach: case studies.Analysis of Amisulpride in Human Plasma by SPE and LC with Fluorescence Detection.A model for calcium permeation into small intestineDevelopment of a liquid chromatography assay for the determination of opicapone and BIA 9-1079 in rat matrices.Hazards in chromatographic bioanalysis method development and applications.Biomarker method validation in anticancer drug developmentValidation of analytic methods for biomarkers used in drug developmentRecommendations and best practices for reference standards and reagents used in bioanalytical method validation.Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs.Bioanalytical issues in patient-friendly sampling methods for therapeutic drug monitoring: focus on antiretroviral drugs.Method validation and application of protein biomarkers: basic similarities and differences from biotherapeutics.Factors affecting the stability of drugs and drug metabolites in biological matrices.Quality requirements for critical assay reagents used in bioanalysis of therapeutic proteins: what bioanalysts should know about their reagents.Incurred sample reanalysis (ISR): a decisive tool in bioanalytical research.Ligand binding assays in the 21st century laboratory: recommendations for characterization and supply of critical reagents.Bioanalytical method validation: An updated review.Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part V - assay performance criteria.Life cycle management of critical ligand-binding reagents.The evolution of guidelines for the validation of flow cytometric methods.Current industrial practices and regulatory requirements to assess analyte and reagent stability using ligand-binding assays.Ligand binding assay critical reagents and their stability: recommendations and best practices from the Global Bioanalysis Consortium Harmonization Team.Stability issues of mycophenolic Acid in plasma: from patient to laboratory.Determination and pharmacokinetic study of gentiopicroside, geniposide, baicalin, and swertiamarin in Chinese herbal formulae after oral administration in rats by LC-MS/MS.Influence of phosvitin and calcium gluconate concentration on permeation and intestinal absorption of calcium ions.An HPLC-DAD method for the simultaneous quantification of opicapone (BIA 9-1067) and its active metabolite in human plasma.Degradation of zopiclone during storage of spiked and authentic whole blood and matching dried blood spots.Evaluation of an isochronic study design for long-term frozen stability investigation of drugs in biological matrices.Serum sample stability in ligand-binding assays: challenges in assessments of long-term, bench-top and multiple freeze-thaw.Simultaneous quantitation of meperidine, normeperidine, tramadol, propoxyphene and norpropoxyphene in human plasma using solid-phase extraction and gas chromatography/mass spectrometry: Method validation and application to cardiovascular safety of tSimultaneous quantification of tobacco alkaloids and major phase I metabolites by LC-MS/MS in human tissue.Bioanalytical method transfer considerations of chromatographic-based assays.Old to new ligand-binding assay method modifications.Aspects of bioanalytical method validation for the quantitative determination of trace elements.
P2860
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P2860
Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples.
description
2007 nî lūn-bûn
@nan
2007年の論文
@ja
2007年論文
@yue
2007年論文
@zh-hant
2007年論文
@zh-hk
2007年論文
@zh-mo
2007年論文
@zh-tw
2007年论文
@wuu
2007年论文
@zh
2007年论文
@zh-cn
name
Best practices during bioanaly ...... y controls, and study samples.
@en
type
label
Best practices during bioanaly ...... y controls, and study samples.
@en
prefLabel
Best practices during bioanaly ...... y controls, and study samples.
@en
P356
P1433
P1476
Best practices during bioanaly ...... y controls, and study samples.
@en
P2093
Eric Woolf
William Nowatzke
P2860
P2888
P304
P356
10.1208/AAPSJ0902013
P407
P577
2007-04-20T00:00:00Z
P5875
P6179
1026154280