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Clinical Pharmacology and Therapeutics|August 6, 2021
Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UKNi A Khin, Cheryl Grandinetti, Hayley Dixey, et al.
Clinical Pharmacology and Therapeutics|November 6, 2025
Evolving Standards: Good Clinical Practice Insights from US FDA, MHRA UK, and Health CanadaCheryl Grandinetti, Mandy Budwal-Jagait, Hocine Abid, et al.
Bioanalysis|November 19, 2016
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, et al.
Clinical Pharmacology and Therapeutics|January 21, 2020
Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice WorkshopNi A Khin, Gail Francis, Jean Mulinde, et al.
Bioanalysis|November 30, 2010
2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidanceNatasha Savoie, Fabio Garofolo, Peter van Amsterdam, et al.
Bioanalysis|October 8, 2016
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, et al.
Bioanalysis|December 24, 2014
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity)Lauren Stevenson, Lakshmi Amaravadi, Heather Myler, et al.
Bioanalysis|December 16, 2014
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, et al.
Bioanalysis|December 3, 2015
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies)Brad Ackermann, Hendrik Neubert, Nicola Hughes, et al.
Bioanalysis|November 18, 2015
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 - small molecules by LCMS)Jan Welink, Eric Fluhler, Nicola Hughes, et al.
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