References
- 1. The 2nd Calibration and Validation Group Workshop on recent issues in Good Laboratory Practice bioanalysis. Bioanalysis 1(1), 19–30 (2009).
- 2. 2009 White Paper on recent issues in regulated bioanalysis from the 3rd Calibration and Validation Group Workshop. Bioanalysis 2(1), 53–68 (2010).
- 3. 2010 White Paper on recent issues in regulated bioanalysis and global harmonization of bioanalytical guidance. Bioanalysis 2(12), 1945–1960 (2010).
- 4. 2011 White Paper on recent issues in bioanalysis and regulatory findings from audits and inspections. Bioanalysis 3(18), 2081–2096 (2011).
- 5. 2012 White Paper on recent issues in bioanalysis and alignment of multiple guidelines. Bioanalysis 4(18), 2213–2226 (2012).
- 6. 2013 White Paper on recent issues in bioanalysis: “hybrid” – the best of LBA & LC/MS. Bioanalysis 5(23), 2903–2918 (2013).
- 7. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1 – small molecules by LCMS). Bioanalysis 6(22), 3039–3049 (2014).
- 8. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 – hybrid LBA/LCMS, ELN & regulatory agencies’ input). Bioanalysis 6(23), 3237–3249 (2014).
- 9. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity). Bioanalysis 6(24), 3355–3368 (2014).
- 10. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 – small molecules by LCMS). Bioanalysis 7(22), 2913–2925 (2015).
- 11. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 – hybrid LBA/LCMS and input from regulatory agencies). Bioanalysis 7(23), 3019–3034 (2015).
- 12. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3 – LBA, biomarkers and immunogenicity). Bioanalysis 7(24), 3107–3124 (2015).
- 13. 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). Bioanalysis 8(22), 2363–2378 (2016).
- 14. 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 – hybrid LBA/LCMS and input from regulatory agencies). Bioanalysis 8(23), 2457–2474 (2016).
- 15. 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 – LBA, biomarkers and immunogenicity). Bioanalysis 8(23), 2475–2496 (2016).
- 16. 2017 White Paper on recent issues in bioanalysis: aren’t BMV guidance/guidelines ‘scientific’? (Part 1 – LCMS: small molecules, peptides and small molecule biomarkers). Bioanalysis 9(22), 1807–1825 (2017).
- 17. 2017 White Paper on recent issues in bioanalysis: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies’ inputs). Bioanalysis 9(23), 1895–1912 (2017).
- 18. 2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 – LBA: immunogenicity, biomarkers and PK assays). Bioanalysis 9(24), 1967–1996 (2017).
- 19. 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). Bioanalysis 10(22), 1781–1801 (2018).
- 20. 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). Bioanalysis 10(23), 1897–1917 (2018).
- 21. 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). Bioanalysis 10(24), 1973–2001 (2018).
- 22. Future Science. Most read Bioanalysis articles. www.future-science.com/journals/bio/mostread
- 23. . The Decennial Index of the White Papers in Bioanalysis: ‘a decade of recommendations (2007–2016)’. Bioanalysis 9(21), 1681–1704 (2017).
- 24. Bioanalysis Zone: The decennial index of White Papers in Bioanalysis: an interview with Natasha Savoie. www.bioanalysis-zone.com/2018/06/22/decennial-index-white-papers-bioanalysis-interview-natasha-savoie/
- 25. Bioanalysis. www.future-science.com/journal/bio
- 26. WRIB: Submit Your Questions to Regulators. www.wrib.org/questions-to-regulators.php