Zobrazeno 1 - 10
of 33
pro vyhledávání: '"Marian Kelley"'
Autor:
Yamamoto Katsuhiko, Daniela Stoellner, Lauren Stevenson, Dongbei Li, Ross Bamford, Arumugam Muruganandam, Christopher Beaver, Marian Kelley, Samantha Little, Paula Gegwich, Ravi Kumar Trivedi
Publikováno v:
The AAPS Journal. 16:221-225
The L1 Global Harmonization Team provides recommendations specifically for run acceptance of ligand binding methods used in bioanalysis of macromolecules in support of pharmacokinetics. The team focused on standard curve calibrators and quality contr
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::072123ac5c416521d7c7a38744967f22
https://doi.org/10.1208/s12248-013-9553-8
https://doi.org/10.1208/s12248-013-9553-8
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:
Russell Weiner, Marian Kelley
This handbook covers established and advanced techniques for biomarker analysis, such as guidelines and strategies for assay validation methods; different mathematical models that are necessary in contemporary drug discovery and development; and eval
Publikováno v:
Bioanalysis for Service Users. :96-107
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::002f391e8d8893453218931601301edd
https://doi.org/10.4155/ebo.13.337
https://doi.org/10.4155/ebo.13.337
Autor:
Marian Kelley, Russell Weiner
Publikováno v:
AAPS Advances in the Pharmaceutical Sciences Series ISBN: 9783319407920
Translating Molecular Biomarkers into Clinical Assays
Translating Molecular Biomarkers into Clinical Assays
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::ff599443f74d3beb55c39b46cca84171
https://doi.org/10.1007/978-3-319-40793-7
https://doi.org/10.1007/978-3-319-40793-7
Autor:
Marian Kelley, Russell Weiner
Publikováno v:
Translating Molecular Biomarkers into Clinical Assays ISBN: 9783319407920
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::505f4df5b8294c8672cbf1c779603260
https://doi.org/10.1007/978-3-319-40793-7_19
https://doi.org/10.1007/978-3-319-40793-7_19
Autor:
Binodh DeSilva, Fabio Garofolo, Mario Rocci, Suzanne Martinez, Isabelle Dumont, France Landry, Catherine Dicaire, Gabriella Szekely-Klepser, Russell Weiner, Mark Arnold, Surendra Bansal, Kevin Bateman, Ronald Bauer, Brian Booth, Scott Davis, Sherri Dudal, Dominique Gouty, John Grundy, Sam Haidar, Roger Hayes, Mohammed Jemal, Surinder Kaur, Marian Kelley, Magnus Knutsson, Olivier Le Blaye, Jean Lee, Steve Lowes, Mark Ma, Toshinari Mitsuoka, João Tavares Neto, Robert Nicholson, Eric Ormsby, Jeffrey Sailstad, Lauren Stevenson, Daniel Tang, Jan Welink, CT Viswanathan, Laixin Wang, Eric Woolf, Eric Yang
Publikováno v:
Bioanalysis. 4:2213-2226
Over 400 professionals representing pharmaceutical companies, CROs, and multiple regulatory agencies participated in the 6th Workshop on Recent Issues in Bioanalysis (WRIB). Like the previous sessions, this event was in the format of a practical, foc
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::1cbabd89dab1ed5a31301fb38c914809
https://doi.org/10.4155/bio.12.205
https://doi.org/10.4155/bio.12.205
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:
Anthony J. DeStefano, Daniel Tang, Jacqueline A. O'Shaughnessy, Marian Kelley, Ajai K. Chaudhary, S. Peter King, Russell Weiner, Douglas M. Fast, C. T. Viswanathan
Publikováno v:
The AAPS Journal. 11:238-241
The Conference Report of the 3rd AAPS/FDA Bioanalytical Workshop (Crystal City III) endorsed the concept that assay methods supporting bioanalytical data in submissions must demonstrate assay reproducibility by using incurred samples. The present Wor
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8701cdb5f80696bcc8caa8e767717bdd
https://doi.org/10.1208/s12248-009-9100-9
https://doi.org/10.1208/s12248-009-9100-9
Autor:
Lola A. Halpin, Laura Akerman, Susan Gue, Susan Pinckard, Jeannie Downey, Richard Gess, Chris Palazzolo, Sue Trowbridge, Joan Moffson, Marian Kelley, Kelly A. Smith, Deberah England, Shannon Astolfi, Kristin Martin, Kurt Blythe
Publikováno v:
Serials Review. 34:214-227
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::655d128b6bcdea4d69525dd81588ac46
https://doi.org/10.1080/00987913.2008.10765180
https://doi.org/10.1080/00987913.2008.10765180