Workshop report: Crystal City V--quantitative bioanalytical method validation and implementation: the 2013 revised FDA guidance. - Wikidata - wikimedia - TriplyDB

Workshop report: Crystal City V--quantitative bioanalytical method validation and implementation: the 2013 revised FDA guidance.

Workshop report: Crystal City V--quantitative bioanalytical method validation and implementation: the 2013 revised FDA guidance.

http://www.wikidata.org/entity/Q35192897

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Involvement of the glutamate/glutamine cycle and glutamate transporter GLT-1 in antidepressant-like effects of Xiao Yao san on chronically stressed mice Large-scale human skin lipidomics by quantitative, high-throughput shotgun mass spectrometry.Rapid evaluation of 25 key sphingolipids and phosphosphingolipids in human plasma by LC-MS/MS.Hazards in chromatographic bioanalysis method development and applications.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.The promise of biomarkers in diagnosing major depression in primary care: the present and future.Parallelism experiments to evaluate matrix effects, selectivity and sensitivity in ligand-binding assay method development: pros and cons.Clinical applications of MS-based protein quantification.Perspectives on variability in pharmacokinetics of an oral contraceptive product.Evaluation of the Anti-Inflammatory Activity of Raisins (Vitis vinifera L.) in Human Gastric Epithelial Cells: A Comparative Study.Effects of blood processing and sample storage on the stability of biotherapeutics and anti-drug antibodies.Workshop Report: AAPS Workshop on Method Development, Validation, and Troubleshooting of Ligand-Binding Assays in the Regulated Environment Calculations for Adjusting Endogenous Biomarker Levels During Analytical Recovery Assessments for Ligand-Binding Assay Bioanalytical Method Validation.Recommendations for validation of LC-MS/MS bioanalytical methods for protein biotherapeutics.The Validation of Quantitative Mass Spectrometry Assays for Clinical Chemistry Assessments in Animal Models.An ultra-sensitive LC-MS/MS method to determine midazolam levels in human plasma: development, validation and application to a clinical study.Novel strategy using tryptic peptide immunoaffinity-based LC-MS/MS to quantify denosumab in monkey serum.2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies).Determination of tigecycline in human plasma by LC-MS/MS and its application to population pharmacokinetics study in Chinese patients with hospital-acquired pneumonia.A highly selective and sensitive LC-MS/HRMS assay for quantifying coproporphyrins as organic anion-transporting peptide biomarkers.Singlicate analysis in regulated bioanalysis using ligand-binding assays: where are we heading?The effect of in vitro gastrointestinal digestion on the anti-inflammatory activity of Vitis vinifera L. leaves.Simultaneous quantitation of the BACE1 inhibitor AZD3293 and its metabolite AZ13569724 in human matrices by LC-MS/MS.Biomarker measurements: how far have we come and where are we heading?Determination of selumetinib, N-desmethyl selumetinib and selumetinib amide in human biological samples by LC-MS/MS.Feedback from the EBF - Focus Workshop: bringing assay validation and analysis of biomarkers into practice.Population pharmacokinetics of artemether, dihydroartemisinin and lumefantrine in Rwandese pregnant women treated for uncomplicated malaria MS-based lipidomics of human blood plasma - a community-initiated position paper to develop accepted guidelines Development and Validation of an HPLC-MS/MS Method for Rapid Simultaneous Determination of Cefprozil Diastereomers in Human Plasma Soluble cMet levels in urine are a significant prognostic biomarker for diabetic nephropathy

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P2860

Workshop report: Crystal City V--quantitative bioanalytical method validation and implementation: the 2013 revised FDA guidance.

http://www.wikidata.org/entity/Q35192897

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2014 nî lūn-bûn

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2014 թուականի Դեկտեմբերին հրատարակուած գիտական յօդուած

@hyw

2014 թվականի դեկտեմբերին հրատարակված գիտական հոդված

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2014年の論文

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2014年論文

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2014年論文

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2014年論文

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2014年論文

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2014年論文

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2014年论文

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The AAPS Journal

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Workshop report: Crystal City ...... the 2013 revised FDA guidance.

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Binodh DeSilva

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Boris Gorovits

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Brian Booth

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Eric Woolf

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Lakshmi Amaravadi

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Lauren Stevenson

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Marie Rock

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Mark E Arnold

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P2860

Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays.

Workshop report and follow-up--AAPS Workshop on current topics in GLP bioanalysis: Assay reproducibility for incurred samples--implications of Crystal City recommendations.

Challenges in developing bioanalytical assays for characterization of antibody-drug conjugates.

Site-specific conjugation of a cytotoxic drug to an antibody improves the therapeutic index.

Contribution of linker stability to the activities of anticancer immunoconjugates.

Key elements of bioanalytical method validation for macromolecules.

Structural characterization of the maytansinoid-monoclonal antibody immunoconjugate, huN901-DM1, by mass spectrometry.

Appropriate calibration curve fitting in ligand binding assays.

Pharmacokinetics and biodistribution of the antitumor immunoconjugate, cantuzumab mertansine (huC242-DM1), and its two components in mice.

Anti-CD22-MCC-DM1 and MC-MMAF conjugates: impact of assay format on pharmacokinetic parameters determination.

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