Fabio Garofolo

发表

The exciting world of oligonucleotides: a multidisciplinary complex challenge for multitasking ingenious bioanalysts.

Yuanxin Xu, Fabio Garofolo, Adrien Musuku, 2019, Bioanalysis.

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity).

Renuka Pillutla, Viswanath Devanarayan, An Song, 2015, Bioanalysis.

2 Bioanalytical report writing

Kevin Bateman, Roger Hayes, Eric Woolf, 2022 .

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1--small molecules by LCMS).

Li Xue, Stacy Ho, Neil Spooner, 2014, Bioanalysis.

2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).

Neil Henderson, Rong Zeng, Renuka Pillutla, 2018, Bioanalysis.

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies).

Barry Jones, Jianing Zeng, An Song, 2016, Bioanalysis.

The 2nd Calibration and Validation Group workshop on recent issues in good laboratory practice bioanalysis.

Fabio Garofolo, Natasha Savoie, Steve Lowes, 2009, Bioanalysis.

Crucial Importance of evaluating internal standards (IS) Response and troubleshooting in effective LCMS method development, validation and sample analysis.

Fabio Garofolo, Stephen Vinter, Seongeun Julia Cho, 2019, Bioanalysis.

2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance.

Eric Woolf, Surendra Bansal, Mohammed Jemal, 2010, Bioanalysis.

Reliable procedures to evaluate and repair crosstalk for bioanalytical MS/MS assays.

Fabio Garofolo, Louis-Philippe Morin, Jean-Nicholas Mess, 2011, Bioanalysis.

Impact of sample hemolysis on drug stability in regulated bioanalysis.

Fabio Garofolo, Milton Furtado, Eugénie-Raphaëlle Bérubé, 2011, Bioanalysis.

International harmonization of bioanalytical guidance.

Fabio Garofolo, Mark Arnold, Surendra K Bansal, 2010, Bioanalysis.

An alternative solution to overcome carryover issues in bioanalysis.

Fabio Garofolo, Louis-Philippe Morin, Milton Furtado, 2012, Bioanalysis.

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity).

Lindsay King, Roger Hayes, Surinder Kaur, 2014, Bioanalysis.

2009 White Paper on recent issues in regulated bioanalysis from the 3rd Calibration and Validation Group Workshop.

Xia Yin, Robert Masse, Fabio Garofolo, 2010, Bioanalysis.

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input).

Lindsay King, Stacy Ho, Roger Hayes, 2014, Bioanalysis.

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 - small molecules by LCMS).

Roger Hayes, Amanda Wilson, Eric Woolf, 2015, Bioanalysis.

"The most important thing is to ensure that the method used for sample ana lysis is selective, because you can be sure that the regulatory agencies will be selective when deciding if your submission is acceptable."

Fabio Garofolo, Natasha Savoie, Annik Bergeron, 2010 .

2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections.

Stacy Ho, Eric Woolf, Binodh DeSilva, 2011, Bioanalysis.

2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS.

Stacy Ho, Roger Hayes, Eric Woolf, 2013, Bioanalysis.

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).

Stephanie Cape, Scott Summerfield, Amanda Wilson, 2016, Bioanalysis.

LC‐MS Instrument Calibration

Fabio Garofolo, 2004 .

Conference report: the 3rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum.

Fabio Garofolo, Rachel Green, Jaap Wieling, 2011, Bioanalysis.

Impact of plasma and whole-blood anticoagulant counter ion choice on drug stability and matrix effects during bioanalysis.

Fabio Garofolo, Annik Bergeron, Mélanie Bergeron, 2009, Bioanalysis.

2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).

Hao Jiang, Amanda Wilson, Eric Woolf, 2017, Bioanalysis.

Large-molecule quantification: sensitivity and selectivity head-to-head comparison of triple quadrupole with Q-TOF.

Fabio Garofolo, Louis-Philippe Morin, Jean-Nicholas Mess, 2013, Bioanalysis.

Formation of a Global Contract Research Organization Council for Bioanalysis.

Xinping Fang, Fabio Garofolo, Chad Briscoe, 2010, Bioanalysis.

Building the Global Bioanalysis Consortium - working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation.

Eric Woolf, Philip Timmerman, Surendra Bansal, 2010, Bioanalysis.

Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis.

Roger Hayes, Zhongping John Lin, Fabio Garofolo, 2011, Bioanalysis.

4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA guidelines, 483s and carryover.

Roger Hayes, Xinping Fang, Fabio Garofolo, 2012, Bioanalysis.

Society spotlight: Spotlight on the calibration and validation group.

Herman Lam, Fabio Garofolo, Wei Garofolo, 2009, Bioanalysis.

Global outsourcing.

Fabio Garofolo, Wei Garofolo, 2010, Bioanalysis.

Recommendations on incurred sample stability (ISS) by GCC.

Stephanie Cape, Roger Hayes, Jennifer Zimmer, 2014, Bioanalysis.

Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC).

Roger Hayes, Xinping Fang, Zhongping John Lin, 2012, Bioanalysis.

Pre-cut dried blood spot (PCDBS): an alternative to dried blood spot (DBS) technique to overcome hematocrit impact.

Fabio Garofolo, Annik Bergeron, Milton Furtado, 2011, Rapid communications in mass spectrometry : RCM.

How to manage having no incurred sample reanalysis evaluation failures.

Fabio Garofolo, Natasha Savoie, Annik Bergeron, 2011, Bioanalysis.

8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.

Roger Hayes, Jennifer Zimmer, Xinping Fang, 2014, Bioanalysis.

Recommendations on biomarker bioanalytical method validation by GCC.

Roger Hayes, Fabio Garofolo, John Allinson, 2012, Bioanalysis.

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies).

Surinder Kaur, Jian Wang, Fabio Garofolo, 2015, Bioanalysis.

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).

Roger Hayes, Jennifer Zimmer, Xinping Fang, 2012, Bioanalysis.

Request for global harmonization of the guidance for Bioanalytical Method Validation and sample analysis.

Philip Timmerman, Fabio Garofolo, Steve Lowes, 2010, Bioanalysis.

Bioanalytical Method Validation

Fabio Garofolo, F. Garofolo, 2004 .

Large molecule bioana lysis using Q-TOF without predigestion and its data processing

Fabio Garofolo, Ab Sciex, F. Garofolo, 2012 .

The 1st conference in Asia-Pacific on Recent Issues in Bioanalysis.

Fabio Garofolo, Isabelle Dumont, F. Garofolo, 2011, Bioanalysis.

Recommendations for Validation of LC-MS/MS Bioanalytical Methods for Protein Biotherapeutics

Surinder Kaur, Jianing Zeng, Faye Vazvaei, 2014, The AAPS Journal.

Recommendations on ISR in multi analyte assays, QA/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC).

Fabio Garofolo, Rachel Green, Colin Pattison, 2012, Bioanalysis.

Characterization of explosives by liquid chromatography/mass spectrometry and liquid chromatography/tandem mass spectrometry using electrospray ionization and parent‐ion scanning techniques

Fabio Garofolo, B. Casetta, F. Garofolo, 1994 .

7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing.

Stephanie Cape, Roger Hayes, Jennifer Zimmer, 2014, Bioanalysis.

2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity).

Eric Woolf, Akiko Ishii-Watabe, Naidong Weng, 2018, Bioanalysis.