Best practices in a tiered approach to metabolite quantification: views and recommendations of the European Bioanalysis Forum.
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Data-driven approach for cross-species comparative metabolite exposure assessment: how to establish fundamental bioanalytical parameters for the peak area ratio method.Development of analytical methods for the quantification of metabolites of lesogaberan in a MIST investigation.Targeted peptide measurements in biology and medicine: best practices for mass spectrometry-based assay development using a fit-for-purpose approach.From definition to implementation: a cross-industry perspective of past, current and future MIST strategies.Radiolabelled mass-balance excretion and metabolism studies in laboratory animals: are they still necessary?The early estimation of circulating drug metabolites in humans.Bioanalysis of drug in tissue: current status and challenges.Measuring soluble biomarkers in clinical trials: do tiered approaches to the analysis and validation of assays provide an answer to the fit-for-purpose challenge?Tiered approach: sense and sensibility.Reflecting on a decade of metabolite screening and monitoring.Application of a tiered approach to the validation of accelerator MS assays.Integrating internal and external bioanalytical support to deliver a diversified pharmaceutical portfolio.Scientific or regulated validation: a tiered approach? Meeting report from a joint EBF/DVDMDG workshop.Survey on the tiered approach for Japanese bioanalysts operated by Japan bioanalysis forum DG2014-09.New frontiers-accelerator mass spectrometry (AMS): Recommendation for best practices and harmonization from Global Bioanalysis Consortium Harmonization Team.Tiered approaches to chromatographic bioanalytical method performance evaluation: recommendation for best practices and harmonization from the Global Bioanalysis Consortium harmonization team.European Bioanalysis Forum recommendation: scientific validation of quantification by accelerator mass spectrometry.Meeting report: metabolites in safety testing (MIST) symposium-safety assessment of human metabolites: what's REALLY necessary to ascertain exposure coverage in safety tests?Are multimetabolite methods fit-for-purpose for supporting toxicology studies?Best practices for metabolite quantification in drug development: updated recommendation from the European Bioanalysis Forum.European Bioanalysis Forum recommendation on method establishment and bioanalysis of biomarkers in support of drug development.Toward best practices in data processing and analysis for intact biotherapeutics by MS in quantitative bioanalysis.Implementing a tiered approach to bioanalytical method validation for large-molecule ligand-binding assay methods in pharmacokinetic assessments.Is the bioanalytical community ready to revise the use of certain validation concepts and nomenclature?Analysis of aluminium in rat following administration of allergen immunotherapy using either aluminium or microcrystalline-tyrosine-based adjuvants.Conference report: the 3rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum.Bioanalysis of chiral compounds during drug development using a tiered approach.An industry perspective on tiered approach to the investigation of metabolites in drug development.The practicalities of a 'fit-for-purpose' validation.A screening UHPLC-MS/MS method for the analysis of amyloid peptides in cerebrospinal fluid of preclinical species.A generic bioanalytical method development strategy and fit-for-purpose qualification to support hERG in vitro sample analysis.Meeting the MIST regulations: human metabolism in Phase I using AMS and a tiered bioanalytical approach.A tiered approach to address regulatory drug metabolite-related issues in drug development.New US FDA draft guidance on bioanalytical method validation versus current FDA and EMA guidelines: chromatographic methods and ISR.
P2860
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P2860
Best practices in a tiered approach to metabolite quantification: views and recommendations of the European Bioanalysis Forum.
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2010 nî lūn-bûn
@nan
2010年の論文
@ja
2010年学术文章
@wuu
2010年学术文章
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2010年学术文章
@zh-cn
2010年学术文章
@zh-hans
2010年学术文章
@zh-my
2010年学术文章
@zh-sg
2010年學術文章
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2010年學術文章
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name
Best practices in a tiered app ...... he European Bioanalysis Forum.
@en
Best practices in a tiered app ...... he European Bioanalysis Forum.
@nl
type
label
Best practices in a tiered app ...... he European Bioanalysis Forum.
@en
Best practices in a tiered app ...... he European Bioanalysis Forum.
@nl
prefLabel
Best practices in a tiered app ...... he European Bioanalysis Forum.
@en
Best practices in a tiered app ...... he European Bioanalysis Forum.
@nl
P2093
P2860
P356
P1433
P1476
Best practices in a tiered app ...... he European Bioanalysis Forum.
@en
P2093
Achim Freisleben
Ben Gordon
Morten Anders Kall
Philip Timmerman
Richard Hucker
Sirpa Laakso
P2860
P304
P356
10.4155/BIO.10.90
P577
2010-07-01T00:00:00Z