1. 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). (November 2016) Authors: Yang, Eric; Welink, Jan; Cape, Stephanie; Woolf, Eric; Sydor, Jens; James, Christopher; Goykhman, Dina; Arnold, Mark; Addock, Neil; Bauer, Ronald; Buonarati, Michael; Ciccimaro, Eugene; Dodda, Raj; Evans, Christopher; Garofolo, Fabio; Hughes, Nicola; Islam, Rafiq; Nehls, Corey; Wilson, Amanda; Br... Journal: Bioanalysis Issue: Volume 8:Number 22(2016) Page Start: 2363 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
2. 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) ↗
3. 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 – LBA, biomarkers and immunogenicity). (November 2016) Authors: Richards, Susan; Amaravadi, Lakshmi; Pillutla, Renuka; Birnboeck, Herbert; Torri, Albert; Cowan, Kyra J.; Papadimitriou, Apollon; Garofolo, Fabio; Satterwhite, Christina; Piccoli, Steven; Wu, Bonnie; Krinos-Fiorotti, Corinna; Allinson, John; Berisha, Flora; Cocea, Laurent; Croft, Stephanie; Frase... Journal: Bioanalysis Issue: Volume 8:Number 23(2016) Page Start: 2475 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
4. 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). (December 2017) Authors: Gupta, Shalini; Richards, Susan; Amaravadi, Lakshmi; Piccoli, Steven; Desilva, Binodh; Pillutla, Renuka; Stevenson, Lauren; Mehta, Devangi; Carrasco-Triguero, Montserrat; Neely, Robert; Partridge, Michael; Staack, Roland F; Zhao, Xuemei; Gorovits, Boris; Kolaitis, Gerry; Sumner, Giane; Stubenrauc... Journal: Bioanalysis Issue: Volume 9:Number 24(2017) Page Start: 1967 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
5. 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) ↗
6. 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) ↗