1. 2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 – LCMS: small molecules, peptides and small molecule biomarkers). (December 2017) Authors: Welink, Jan; Yang, Eric; Hughes, Nicola; Rago, Brian; Woolf, Eric; Sydor, Jens; Coppola, Laura; Ackermann, Brad; Li, Wenkui; Alley, Stephen C; Arnold, Mark; Berger, Isabella; Briscoe, Chad; Buonarati, Michael; Bustard, Mark; Cancilla, Mark; Cho, Seongeun (Julia); Duggan, Jeff; Fraier, Daniela; Ga... Journal: Bioanalysis Issue: Volume 9:Number 22(2017) Page Start: 1807 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
2. 2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs). (December 2017) Authors: Neubert, Hendrik; Song, An; Lee, Anita; Wei, Cong; Duggan, Jeff; Xu, Keyang; Woolf, Eric; Evans, Chris; Palandra, Joe; Laterza, Omar; Amur, Shashi; Berger, Isabella; Bustard, Mark; Cancilla, Mark; Chen, Shang-Chiung; Cho, Seongeun (Julia); Ciccimaro, Eugene; Cludts, Isabelle; Cocea, Laurent; D'Ar... Journal: Bioanalysis Issue: Volume 9:Number 23(2017) Page Start: 1895 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
3. Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK. Issue 1 (30th August 2021) Authors: Khin, Ni A.; Grandinetti, Cheryl; Dixey, Hayley; Yu, Bei; Skeete, Rachel; Ayalew, Kassa; Budwal‐Jagait, Mandy; Cho, Seongeun‐Julia; Dasgupta, Arindam; Fisher, Andrew; Kleppinger, Cynthia; Kronstein, Phillip D.; Martin, Jennifer; McGuinness, Michael; Mulinde, Jean; Vinter, Stephen; Wakelin‐Smith, ... Journal: Clinical pharmacology & therapeutics Issue: Volume 112:Issue 1(2022) Page Start: 31 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
4. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 – small molecules by LCMS). (November 2015) Authors: Welink, Jan; Fluhler, Eric; Hughes, Nicola; Arnold, Mark; Garofolo, Fabio; Bustard, Mark; Coppola, Laura; Dhodda, Raj; Evans, Christopher; Gleason, Carol; Haidar, Sam; Hayes, Roger; Heinig, Katja; Katori, Noriko; Blaye, Olivier Le; Li, Wenkui; Liu, Guowen; Lima Santos, Gustavo Mendes; Meng, Min; ... Journal: Bioanalysis Issue: Volume 7:Number 22(2015) Page Start: 2913 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
5. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 – small molecules by LCMS). (November 2015) Authors: Welink, Jan; Fluhler, Eric; Hughes, Nicola; Arnold, Mark; Garofolo, Fabio; Bustard, Mark; Coppola, Laura; Dhodda, Raj; Evans, Christopher; Gleason, Carol; Haidar, Sam; Hayes, Roger; Heinig, Katja; Katori, Noriko; Blaye, Olivier Le; Li, Wenkui; Liu, Guowen; Lima Santos, Gustavo Mendes; Meng, Min; ... Journal: Bioanalysis Issue: Volume 7:Number 22(2015) Page Start: 2913 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
6. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 – hybrid LBA/LCMS and input from regulatory agencies). (December 2015) Authors: Ackermann, Brad; Neubert, Hendrik; Hughes, Nicola; Garofolo, Fabio; Abberley, Lee; Alley, Stephen C; Brown-Augsburger, Patricia; Bustard, Mark; Chen, Lin-zhi; Heinrich, Julia; Katori, Noriko; Kaur, Surinder; Kirkovsky, Leo; Laterza, Omar F; Le Blaye, Olivier; Lévesque, Ann; Santos, Gustavo Mendes... Journal: Bioanalysis Issue: Volume 7:Number 23(2015) Page Start: 3019 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
7. 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 – Hybrid LBA/LCMS and input from regulatory agencies). (December 2016) Authors: Song, An; Lee, Anita; Garofolo, Fabio; Kaur, Surinder; Duggan, Jeff; Evans, Christopher; Palandra, Joe; Donato, Lorella Di; Xu, Keyang; Bauer, Ronald; Bustard, Mark; Chen, Linzhi; Cocea, Laurent; Croft, Stephanie; Galliccia, Fabrizio; Haidar, Sam; Hughes, Nicola; Ishii-Watabe, Akiko; Islam, Rafiq... Journal: Bioanalysis Issue: Volume 8:Number 23(2016) Page Start: 2457 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
8. 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). (29th November 2018) Authors: Neubert, Hendrik; Olah, Timothy; Lee, Anita; Fraser, Stephanie; Dodge, Robert; Laterza, Omar; Szapacs, Matthew; Alley, Stephen C; Saad, Ola M; Amur, Shashi; Chen, Linzhi; Cherry, Elana; Cho, Seongeun (Julia); Cludts, Isabelle; Donato, Lorella Di; Edmison, Anna; Ferrari, Luca; Garofolo, Fabio; Hai... Journal: Bioanalysis Issue: Volume 10:Number 23(2018) Page Start: 1897 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
9. 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). (29th November 2018) Authors: Welink, Jan; Xu, Yuanxin; Yang, Eric; Wilson, Amanda; Henderson, Neil; Luo, Lina; Fraser, Stephanie; Kavita, Uma; Musuku, Adrien; James, Christopher; Fraier, Daniela; Zhang, Yan; Goykhman, Dina; Summerfield, Scott; Woolf, Eric; Verhaeghe, Tom; Hughes, Nicola; Behling, Alexander; Brown, Kirk; Buly... Journal: Bioanalysis Issue: Volume 10:Number 22(2018) Page Start: 1781 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
10. 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 Workshop. Issue 5 (28th March 2020) Authors: Khin, Ni A.; Francis, Gail; Mulinde, Jean; Grandinetti, Cheryl; Skeete, Rachel; Yu, Bei; Ayalew, Kassa; Cho, Seongeun‐Julia; Fisher, Andrew; Kleppinger, Cynthia; Ayala, Ruben; Bonapace, Charles; Dasgupta, Arindam; Kronstein, Phillip D.; Vinter, Stephen Journal: Clinical pharmacology & therapeutics Issue: Volume 108:Issue 5(2020) Page Start: 949 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗