Publications by authors named "Jason Wakelin-Smith"

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Evolving Standards: Good Clinical Practice Insights from US FDA, MHRA UK, and Health Canada.
Cheryl Grandinetti, Mandy Budwal-Jagait, Hocine Abid, Emily Gebbia, Elena Boley, Jason Wakelin-Smith

Clin Pharmacol Ther· November 2025

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Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK.
Ni A Khin, Cheryl Grandinetti, Hayley Dixey, Bei Yu, Rachel Skeete, Jason Wakelin-Smith

Clin Pharmacol Ther· July 2022

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Conduct of remote inspections: challenges and progress.
Jason Wakelin-Smith, Stephen Vinter

Bioanalysis· December 2021

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2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies).
An Song, Anita Lee, Fabio Garofolo, Surinder Kaur, Jeff Duggan, Jason Wakelin-Smith

Bioanalysis· December 2016

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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, Jason Wakelin-Smith

Bioanalysis· November 2016

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2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input).
Dawn Dufield, Hendrik Neubert, Fabio Garofolo, Leo Kirkovsky, Lauren Stevenson, Jason Wakelin-Smith

Bioanalysis· August 2015

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2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity).
Lauren Stevenson, Lakshmi Amaravadi, Heather Myler, Laura Salazar-Fontana, Boris Gorovits, Jason Wakelin-Smith

Bioanalysis· August 2015

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2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1--small molecules by LCMS).
Eric Fluhler, Roger Hayes, Fabio Garofolo, Isabelle Dumont, Olivier Le Blaye, Jason Wakelin-Smith

Bioanalysis· July 2015

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2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS.
Lauren Stevenson, Fabio Garofolo, Binodh DeSilva, Isabelle Dumont, Suzanne Martinez, Jason Wakelin-Smith

Bioanalysis· December 2013

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2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance.
Natasha Savoie, Fabio Garofolo, Peter van Amsterdam, Surendra Bansal, Chris Beaver, Jason Wakelin-Smith

Bioanalysis· December 2010

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