2013 White Paper on recent issues in bioanalysis: ‘hybrid’ – the best of LBA and LCMS

作者: Lauren Stevenson , Fabio Garofolo , Binodh DeSilva , Isabelle Dumont , Suzanne Martinez

DOI: 10.4155/BIO.13.238

关键词:

摘要: The 2013 7th Workshop on Recent Issues in Bioanalysis was held Long Beach, California, USA, where close to 500 professionals from pharmaceutical and biopharmaceutical companies, CROs regulatory agencies convened discuss current topics of interest bioanalysis. These ‘hot’ topics, which covered both small large molecules, were the starting point for fruitful exchanges knowledge, sharing ideas among speakers, panelists attendees. discussions led specific recommendations pertinent bioanalytical science. Such as previous editions, this White Paper addresses important issues provides practical answers presented, discussed agreed upon by global community attending Bioanalysis.

参考文章(26)
D. Rodbard, Y. Feldman, M.L. Jaffe, L.E.M. Miles, Kinetics of two-site immunoradiometric (‘sandwich’) assays—II Immunochemistry. ,vol. 15, pp. 77- 82 ,(1978) , 10.1016/0161-5890(78)90046-9
D. Rodbard, Y. Feldman, Kinetics of two-site immunoradiometric (‘sandwich’) assays—I Immunochemistry. ,vol. 15, pp. 71- 76 ,(1978) , 10.1016/0161-5890(78)90045-7
Marian Kelley, Ago B. Ahene, Boris Gorovits, John Kamerud, Lindsay E. King, Thomas McIntosh, Jihong Yang, Theoretical Considerations and Practical Approaches to Address the Effect of Anti-drug Antibody (ADA) on Quantification of Biotherapeutics in Circulation The AAPS Journal. ,vol. 15, pp. 646- 658 ,(2013) , 10.1208/S12248-013-9468-4
Richard Hougton, Dominique Gouty, John Allinson, Rachel Green, Mike Losauro, Steve Lowes, Richard LeLacheur, Fabio Garofolo, Philippe Couerbe, Stéphane Bronner, Petra Struwe, Christine Schiebl, Timothy Sangster, Colin Pattison, Rafiq Islam, Wei Garofolo, Maria Pawula, Mike Buonarati, Roger Hayes, Mark Cameron, Robert Nicholson, Jake Harman, Jaap Wieling, Theo De Boer, Scott Reuschel, Laura Cojocaru, Tammy Harter, Michele Malone, William Nowatzke, Recommendations on biomarker bioanalytical method validation by GCC Bioanalysis. ,vol. 4, pp. 2439- 2446 ,(2012) , 10.4155/BIO.12.197
Robert A Hamilton, William R Garnett, Berry J Kline, Determination of mean valproic acid serum level by assay of a single pooled sample Clinical Pharmacology and Therapeutics. ,vol. 29, pp. 408- 413 ,(1981) , 10.1038/CLPT.1981.56
Massimo Breda, Fabio Garofolo, Maria Cruz Caturla, Philippe Couerbe, John Maltas, Peter White, Petra Struwe, Timothy Sangster, Suzanne Riches, Jim Hillier, Wei Garofolo, Thomas Zimmerman, Maria Pawula, Eileen Collins, Dick Schoutsen, Jaap Wieling, Rachel Green, Richard Houghton, Bernard Jeanbaptiste, Quinton Claassen, Tammy Harter, Mark Seymour, Conference report: the 3rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum. Bioanalysis. ,vol. 3, pp. 2721- 2727 ,(2011) , 10.4155/BIO.11.242
Shalini Gupta, Viswanath Devanarayan, Deborah Finco, George R. Gunn, Susan Kirshner, Susan Richards, Bonita Rup, An Song, Meena Subramanyam, Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics. Journal of Pharmaceutical and Biomedical Analysis. ,vol. 55, pp. 878- 888 ,(2011) , 10.1016/J.JPBA.2011.03.038
M O’Mara, B Hudson-Curtis, K Olson, Y Yueh, J Dunn, N Spooner, The effect of hematocrit and punch location on assay bias during quantitative bioanalysis of dried blood spot samples. Bioanalysis. ,vol. 3, pp. 2335- 2347 ,(2011) , 10.4155/BIO.11.220
Jean W. Lee, Marian Kelley, Lindsay E. King, Jihong Yang, Hossein Salimi-Moosavi, Meina T. Tang, Jian-Feng Lu, John Kamerud, Ago Ahene, Heather Myler, Cindy Rogers, Bioanalytical Approaches to Quantify “Total” and “Free” Therapeutic Antibodies and Their Targets: Technical Challenges and PK/PD Applications Over the Course of Drug Development Aaps Journal. ,vol. 13, pp. 99- 110 ,(2011) , 10.1208/S12248-011-9251-3
Steve Lowes, Jim Jersey, Ronald Shoup, Fabio Garofolo, Natasha Savoie, Ejvind Mortz, Shane Needham, Maria Cruz Caturla, Ray Steffen, Curtis Sheldon, Roger Hayes, Tim Samuels, Lorella Di Donato, John Kamerud, Steve Michael, Zhongping (John) Lin, Jim Hillier, Marc Moussallie, Leonardo de Souza Teixeira, Mario Rocci, Mike Buonarati, James Truog, Saleh Hussain, Richard Lundberg, Alan Breau, Tianyi Zhang, Jianine Jonker, Neil Berger, Sofi Gagnon-Carignan, Corey Nehls, Robert Nicholson, Martijn Hilhorst, Shane Karnik, Theo de Boer, Richard Houghton, Kirk Smith, Laura Cojocaru, Mike Allen, Tammy Harter, Saadya Fatmi, Farhad Sayyarpour, Jenifer Vija, Michele Malone, Dennis Heller, Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis Bioanalysis. ,vol. 3, pp. 1323- 1332 ,(2011) , 10.4155/BIO.11.135