Publications by authors named "Daniela Fraier"

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Metabolite Bioanalysis in Drug Development: Recommendations from the IQ Consortium Metabolite Bioanalysis Working Group.
Wenkui Li, Faye Vazvaei-Smith, Gordon Dear, Jason Boer, Filip Cuyckens, Daniela Fraier

Clin Pharmacol Ther· May 2024

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2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs ( - Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC &  - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Surinder Kaur, Stephen C Alley, Matt Szapacs, Amanda Wilson, Eugene Ciccimaro, Daniela Fraier

Bioanalysis· May 2022

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2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome ( - Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos).
Hendrik Neubert, Stephen C Alley, Anita Lee, Wenying Jian, Michael Buonarati, Daniela Fraier

Bioanalysis· February 2021

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Bioanalytical aspects and challenges in supporting pediatric drug development.
Katja Heinig, Elke Zwanziger, Julian Potter, Daniela Fraier

Bioanalysis· November 2020

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2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs ( - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity).
Brian Booth, Lauren Stevenson, Renuka Pillutla, Michael Buonarati, Chris Beaver, Daniela Fraier

Bioanalysis· December 2019

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Inconsistent internal standard response in LC-MS/MS bioanalysis: an evaluation of case studies.
Daniela Fraier, Luca Ferrari, Katja Heinig, Elke Zwanziger

Bioanalysis· September 2019

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2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1 - small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis).
Jan Welink, Yuanxin Xu, Eric Yang, Amanda Wilson, Neil Henderson, Daniela Fraier

Bioanalysis· November 2018

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Ocular bioanalysis: challenges and advancements in recent years for these rare matrices.
Katja Heinig, Enric Bertran, Julian Potter, Daniela Fraier

Bioanalysis· December 2017

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2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers).
Jan Welink, Eric Yang, Nicola Hughes, Brian Rago, Eric Woolf, Daniela Fraier

Bioanalysis· November 2017

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LC-MS/MS determination of alectinib and its major human metabolite M4 in human urine: prevention of nonspecific binding.
Katja Heinig, Denis Herzog, Luca Ferrari, Daniela Fraier, Kazuhiro Miya

Bioanalysis· March 2017

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An ultra-sensitive LC-MS/MS method to determine midazolam levels in human plasma: development, validation and application to a clinical study.
Mu Chen, Wenzhe Lu, Yang Lu, Lijuan Kang, Harry Zhao, Daniela Fraier

Bioanalysis· February 2017

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2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 - small molecules, peptides and small molecule biomarkers by LCMS).
Eric Yang, Jan Welink, Stephanie Cape, Eric Woolf, Jens Sydor, Daniela Fraier

Bioanalysis· November 2016

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Clinical Micro-Dose Studies to Explore the Human Pharmacokinetics of Four Selective Inhibitors of Human Nav1.7 Voltage-Dependent Sodium Channels.
Hannah M Jones, Richard P Butt, Rob W Webster, Ian Gurrell, Pawel Dzygiel, Daniela Fraier

Clin Pharmacokinet· July 2016

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Bioanalysis of alectinib and metabolite M4 in human plasma, cross-validation and impact on PK assessment.
Katja Heinig, Kazuhiro Miya, Tomonori Kamei, Elena Guerini, Daniela Fraier

Bioanalysis· July 2016

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Evaluation of metaquant microdialysis for measurement of absolute concentrations of amphetamine and dopamine in brain: a viable method for assessing pharmacokinetic profile of drugs in the brain.
Pooja Sood, Susan Cole, Daniela Fraier, Andrew M J Young

J Neurosci Methods· December 2009

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Sensitive quantitation of reboxetine enantiomers in rat plasma and brain, using an optimised reverse phase chiral LC-MS/MS method.
Paul Turnpenny, Daniela Fraier

J Pharm Biomed Anal· January 2009

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Development of a micro-turbulent flow chromatography focus mode method for drug quantitation in discovery bioanalysis.
Paul Turnpenny, Daniela Fraier, Christophe Chassaing, Jonathan Duckworth

J Chromatogr B Analyt Technol Biomed Life Sci· September 2007

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Evaluation of water-compatible molecularly imprinted polymers as solid-phase extraction sorbents for the selective extraction of sildenafil and its desmethyl metabolite from plasma samples.
Paweł Dzygiel, Elizabeth O'Donnell, Daniela Fraier, Christophe Chassaing, Peter A G Cormack

J Chromatogr B Analyt Technol Biomed Life Sci· June 2007

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Ion-suppression effects in liquid chromatography-tandem mass spectrometry due to a formulation agent, a case study in drug discovery bioanalysis.
Patrice J Larger, Massimo Breda, Daniela Fraier, Heather Hughes, Christopher A James

J Pharm Biomed Anal· September 2005

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