Zobrazeno 1 - 10
of 80
pro vyhledávání: '"Jean W. Lee"'
Publikováno v:
Biomarkers in Drug Discovery and Development. :149-176
The use of novel biomarkers has become a prominent component of decision-making processes in drug development. They are used in the in vitro and preclinical models and early clinical phase for quick-hit and early-attrition decisions. This article foc
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8635a3ff1c7932e33c9d4e7c7f8bf59a
https://doi.org/10.1002/9781119187547.ch9
https://doi.org/10.1002/9781119187547.ch9
Autor:
Jean W Lee
Publikováno v:
Bioanalysis. 8:19-27
Monoclonal antibody (mAb) and mAb-derived biotherapeutics are being developed to interact with specific target molecule(s) to intervene disease formation or progression. LC–MS/MS methods have emerged to compensate for the limitations of conventiona
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f12446b437384cca5978115d1ce5aff4
https://doi.org/10.4155/bio.15.231
https://doi.org/10.4155/bio.15.231
Autor:
Sam Haidar, Stacy Ho, Lauren Stevenson, Surinder Kaur, Jeff Duggan, Alvydas Mikulskis, Jian Wang, Judy Shih, Magnus Knutsson, Lakshmi Amaravadi, Boris Gorovits, Rand Jenkins, Steve Lowes, Hanlan Liu, Mark Ma, Binodh DeSilva, Ronald Shoup, Emma Whale, Chad Ray, Christopher P. Evans, Marian Kelley, Jean W. Lee, An Song, João Tavares Neto, Bob Nicholson, Laixin Wang, Dominique Gouty, Rafiq Islam, Suzanne Martinez, Mike Losauro, Isabelle Dumont, Adrien Musuku, Dawn Dufield, Vincenzo Pucci, Shefali Patel, Eric Ormsby, Laura Wright, Margarete Brudny-Kloeppel, Valerie Theobald, Gary Schultz, Stephanie Fraser, Timothy V Olah, Noriko Katori, Richard Houghton, Mark E. Arnold, Eric Fluhler, Catherine Dicaire, Eric Woolf, Sherri Dudal, Fabio Garofolo, Jan Welink, Mario Rocci, Laurence Mayrand-Provencher, Heather Myler, Raymond Naxing Xu, Jason Wakelin-Smith, Brian Booth, Roger Hayes, Craig Simon, Surendra Bansal, Theingi M. Thway
Publikováno v:
Bioanalysis. 5:2903-2918
The 2013 7th Workshop on Recent Issues in Bioanalysis was held in Long Beach, California, USA, where close to 500 professionals from pharmaceutical and biopharmaceutical companies, CROs and regulatory agencies convened to discuss current topics of in
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::400e67f136ad0c817f027df1f325d6f2
https://doi.org/10.4155/bio.13.238
https://doi.org/10.4155/bio.13.238
Autor:
Jean W. Lee
Publikováno v:
Bioanalysis. 5:2003-2014
Absorption, distribution, metabolism and excretion (ADME) data are pivotal for small-molecule drug development, with well-developed in vitro and in vivo correlation tools and guidances from regulatory agencies. In the past two decades, monoclonal ant
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d3b3d3ad8f0a9b81ac7770e71372ebab
https://doi.org/10.4155/bio.13.144
https://doi.org/10.4155/bio.13.144
Autor:
Maria V. Panchenko, Mina I. Zhou, Rebecca L. Foy, Alessandra Boletta, Vipul C. Chitalia, Gregory G. Germino, Herbert T. Cohen, Jean W. Lee, Shaunak V. Rana, Klaus Piontek, Feng Qian, Leonidas Tsiokas, Delia Lopez, Liling Zeng
Publikováno v:
Human Molecular Genetics. 21:5456-5471
Autosomal-dominant polycystic kidney disease (ADPKD) and von Hippel-Lindau (VHL) disease lead to large kidney cysts that share pathogenetic features. The polycystin-1 (PC1) and pVHL proteins may therefore participate in the same key signaling pathway
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7183b1f402fe8951ac8dc74c513153c9
https://doi.org/10.1093/hmg/dds391
https://doi.org/10.1093/hmg/dds391
Autor:
Ken Walker, Sterling Miller, Jean W. Lee, Chris Spahr, John Laudemann, Hongyan Li, Hossein Salimi-Moosavi, Robert Ortiz, Linh Tran, Michael Hall
Publikováno v:
Analytical Chemistry. 84:1267-1273
Ligand binding assays (LBAs) are widely used for therapeutic monoclonal antibody (mAb) quantification in biological samples. Major limitations are long method development times, reagent procurement, and matrix effects. LC-MS/MS methods using signatur
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::44579daf1b239c95a5f4efcec500a093
https://doi.org/10.1021/ac202792n
https://doi.org/10.1021/ac202792n
2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and Inspections
Autor:
Robert Nicholson, Eric Ormsby, Corey Nehls, Mario Rocci, Olivier Le Blaye, CT Viswanathan, Mohammed Jemal, Isabelle Dumont, Jean W. Lee, Daniel Tang, Steve Lowes, Stacy Ho, Peter van Amsterdam, Surendra Bansal, Fabio Garofolo, Steve Michael, Graeme Young, Ronald Bauer, Keith Gallicano, Russell Weiner, Richard Hucker, Brian Booth, Noriko Katori, Montserrat Carrasco-Triguero, Binodh DeSilva, Wenkui Li, Ariadna Cristina Gomes Barra, Suzanne Martinez, Eric Woolf, John Dunn, Dominique Gouty
Publikováno v:
Bioanalysis. 3:2081-2096
The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for pharmaceutical companies, CROs and regulatory agencies to discuss, review, share perspectives, provid
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::56f3bb46ad8031b74395947656f3f6b3
https://doi.org/10.4155/bio.11.192
https://doi.org/10.4155/bio.11.192
Autor:
Marian Kelley, Jean W. Lee
Publikováno v:
Therapeutic Delivery. 2:383-396
Monoclonal antibody biotherapeutics are developed to bind to a specific target to affect the target’s biological effect. Reliable measurements of monoclonal antibodies in biological fluids using ligand-binding assays are vital for understanding the
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6509d7ce8a888cbfc37ad899f7bf242a
https://doi.org/10.4155/tde.10.99
https://doi.org/10.4155/tde.10.99
Autor:
Lennie Uy, Han Gunn, Lei Zhou, Jennifer Malella, Binodh DeSilva, Jessie Gu, Jean W. Lee, Chad A. Ray, Jennifer Tsoi, Mark Ma, Danielle DeSimone
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 53:729-734
Outsourcing and multi-site testing has increased for ligand binding assays supporting protein therapeutic measurement. It is common to combine and compare data across studies with data from multiple bioanalytical sites. We designed a prospective stud
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5c25a8f60401c61a62edb2ec1bfc6767
https://doi.org/10.1016/j.jpba.2010.04.022
https://doi.org/10.1016/j.jpba.2010.04.022
Autor:
Michael Hall, Hsieng Sen Lu, Christopher S. Spahr, Robert Ortiz, Steven Yu, Colin V. Gegg, Kenneth W. Walker, Jean W. Lee, Vimal Patel, Liana Zhang, Binodh DeSilva
Publikováno v:
The AAPS Journal. 12:576-585
The knowledge of in vivo biotransformation (e.g., proteolysis) of protein therapeutic candidates reveals structural liabilities that impact stability. This information aids the development and confirmation of ligand-binding assays with the required s
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::180ca94a2bdcef05a7dfaace19bdf26c
https://doi.org/10.1208/s12248-010-9218-9
https://doi.org/10.1208/s12248-010-9218-9