Zobrazeno 1 - 10
of 34
pro vyhledávání: '"Darshana Jani"'
Publikováno v:
AAPS Open, Vol 4, Iss 1, Pp 1-14 (2018)
Abstract Introduction Inotuzumab ozogamicin (InO) is an antibody-drug conjugate composed of a recombinant, humanized immunoglobulin type G, subtype 4 (IgG4) antibody covalently bound to a semisynthetic derivative of calicheamicin via an acid-labile l
Externí odkaz:
https://doaj.org/article/2cf9ad13f33148eca84ceb3d860adb2b
Autor:
Lisa R. Hartman, Ildar Nurmeev, Pavel Svirin, Kevin D. Wolter, Jean Li Yan, Darshana Jani, Neil A. Goldenberg, Nancy Sherman
Publikováno v:
Pediatric Blood & Cancer. 69
Data from registrational trials of pediatric venous thromboembolism (VTE) treatment are sparse, especially among cancer patients. We conducted a prospective, multicenter, open-label trial (NCT00952380) on dose-finding, safety, and efficacy (measured
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ee1024bc31ef45fb6b87473d866acc54
https://doi.org/10.1002/pbc.29764
https://doi.org/10.1002/pbc.29764
Publikováno v:
Journal of Clinical Pharmacology
This article describes the population pharmacokinetics (PK) of dalteparin in pediatric patients with venous thromboembolism (VTE). A prospective multicenter open‐label study was conducted in children who required anticoagulation for the treatment o
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::973a313c085769d8b2982c10208c5c77
http://europepmc.org/articles/PMC7818112
http://europepmc.org/articles/PMC7818112
Publikováno v:
An Introduction to Bioanalysis of Biopharmaceuticals ISBN: 9783030971922
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::05fd6355a6a41e2c844dc7ca96e6787b
https://doi.org/10.1007/978-3-030-97193-9_5
https://doi.org/10.1007/978-3-030-97193-9_5
Publikováno v:
AAPS Open, Vol 4, Iss 1, Pp 1-14 (2018)
Introduction Inotuzumab ozogamicin (InO) is an antibody-drug conjugate composed of a recombinant, humanized immunoglobulin type G, subtype 4 (IgG4) antibody covalently bound to a semisynthetic derivative of calicheamicin via an acid-labile linker. It
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::33aa9bb3fdd648b1d45c0bae35565653
http://link.springer.com/article/10.1186/s41120-018-0021-5
http://link.springer.com/article/10.1186/s41120-018-0021-5
Autor:
Medha Kamat, Damien Fink, Yuda Zhu, Yan G. Ni, Mark Cameron, Renee Riffon, Lakshmi Amaravadi, Kyra J. Cowan, Darshana Jani, Robert Neely, Lindsay King, Paul Rhyne
Publikováno v:
The AAPS Journal. 19:1550-1563
As biomarkers continue to become an integral part of drug development and decision-making, there are increased expectations for reliable and quantitative assays. Protein biomarker assay results are directly influenced by the calibrator material. The
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f7c8d89302e5554d6f843fa0e7bf540a
https://doi.org/10.1208/s12248-017-0146-9
https://doi.org/10.1208/s12248-017-0146-9
Autor:
Akiko Ishii-Watabe, Albert Torri, Rong Zeng, Daniel Kramer, Steven P. Piccoli, David J. Uhlinger, Stephanie Fraser, Patricia Siguenza, Afshin Safavi, John Smeraglia, Apollon Papadimitriou, Yan G. Ni, Susan M. Richards, Kyra J. Cowan, Alessandra Vitaliti, Lakshmi Amaravadi, Boris Gorovits, Gustavo Mendes Lima Santos, John Kadavil, Sam Haidar, Jan Welink, Yongchang Qiu, João Pedras-Vasconcelos, Chan C. Whiting, Li Xue, Christina Satterwhite, John Kamerud, Swati Gupta, Natasha Savoie, Herbert Birnboeck, Yoshiro Saito, Paul Rhyne, Fabrizio Galliccia, Laurent Cocea, Stephanie Croft, Bonnie Wu, Theingi M. Thway, Virginia Litwin, Corinna Krinos-Fiorotti, Darshana Jani, Charles S Hottenstein, Vinita Gupta, Roland F Staack, Fabio Garofolo, Eginhard Schick, Kara Scheibner, Meena Subramanyam, John Allinson, Renuka Pillutla, Robert Nelson, Flora Berisha, Martin Ullmann, Giane Sumner
Publikováno v:
Bioanalysis. 8:2475-2496
The 2016 10th Workshop on Recent Issues in Bioanalysis (10th WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizatio
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9a67282718390ee4d7f9eb9599bdcf67
https://doi.org/10.4155/bio-2016-4989
https://doi.org/10.4155/bio-2016-4989
Autor:
Boris Gorovits, Marcela Araya Roldan, John Kamerud, Daniel Baltrukonis, Chun-Hua Cai, Jean Donley, Ying Wang, Jeffrey S. Thomas, Frederick McCush, Darshana Jani
Publikováno v:
The AAPS journal. 21(5)
Anti-drug antibody (ADA) assay selectivity is evaluated during assay validation to assess the potential for individual matrices to interfere with detection of ADA. While current EMA and FDA guideline documents suggest comparative analysis with and wi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2e5ec18867850b67ea93bc06f56ccecd
https://pubmed.ncbi.nlm.nih.gov/31214862
https://pubmed.ncbi.nlm.nih.gov/31214862
Autor:
Boris Gorovits, Alison Joyce, Darshana Jani, Katrina Olson, Chuenlei Parng, Elena Seletskaia, Teresa M Caiazzo, Jean Donley, Yuhong Xiang
Publikováno v:
The AAPS journal. 21(3)
Immunogenicity is a major challenge for protein therapeutics which can potentially reduce drug efficacy and safety and is often being monitored by anti-drug antibody (ADA) and neutralizing antibody (NAb) assays. Circulating targets and residual drugs
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9015006e9e73ded46eaa6e3771c2dcec
https://pubmed.ncbi.nlm.nih.gov/30927117
https://pubmed.ncbi.nlm.nih.gov/30927117
Autor:
Pekka Kurki, Robert Neely, Akiko Ishii-Watabe, Soma Ray, Yanhua Zhang, Giane Sumner, Susan M. Richards, Lorella Di Donato, Roland F Staack, Charles S Hottenstein, Seongeun Julia Cho, Saloumeh K Fischer, Lauren Stevenson, Jim McNally, Jonathan Haulenbeek, Lilian Yengi, John Smeraglia, Boris Gorovits, Yuanxin Xu, Jenny Hu, Joe Bower, Ashley Mullan, Yan Zhang, Rafiq Islam, Daniel Kramer, Tong-Yuan Yang, John Kadavil, Flora Berisha, Barry van der Strate, Linglong Zou, Laurent Cocea, Kay-Gunnar Stubenrauch, Gerry Kolaitis, Renuka Pillutla, Lakshmi Amaravadi, Thorsten Verch, Chris Beaver, John Kamerud, Marianne Scheel Fjording, Fabio Garofolo, Xuemei Zhao, Yoshiro Saito, Shashi Amur, An Song, Stephen J. Zoog, Kara Scheibner, João Pedras-Vasconcelos, Natasha Savoie, Sam Haidar, Bruce Stouffer, Isabelle Cludts, Binodh DeSilva, Jianing Zeng, Montserrat Carrasco-Triguero, Afshin Safavi, Apollon Papadimitriou, Darshana Jani, Isabella Berger, Michael A Partridge, Jan Welink, Shalini Gupta, Devangi Mehta, Stephen MacMannis, Herbert Birnboeck, Nilufer Tampal, Steven P. Piccoli, Stephanie Fraser
Publikováno v:
Bioanalysis. 9(24)
The 2017 11th Workshop on Recent Issues in Bioanalysis took place in Los Angeles/Universal City, California, on 3–7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::62bf96cba6584d17b853103a8dbb1b10
https://pubmed.ncbi.nlm.nih.gov/29205064
https://pubmed.ncbi.nlm.nih.gov/29205064