Zobrazeno 1 - 10
of 41
pro vyhledávání: '"Yow-Ming Wang"'
Publikováno v:
Clinical and Translational Science, Vol 15, Iss 9, Pp 2096-2104 (2022)
Abstract Biologics are increasingly being co‐developed in combination or as novel constructs like bispecific antibodies (BsAbs) with the goal of targeting multiple, non‐redundant mechanisms of action. Rational design of combinations and dual‐ta
Externí odkaz:
https://doaj.org/article/ae37e1032b2d439ca81d90dac0679a18
Autor:
Yow‐Ming Wang, David G. Strauss
Publikováno v:
Clinical Pharmacology & Therapeutics. 113:11-15
Autor:
Jeffry Florian, Qin Sun, Sarah J. Schrieber, Richard White, Sophie Shubow, Bernadette E. Johnson‐Williams, Morasa Sheikhy, Nicholas R. Harrison, Valerie J. Parker, Yow‐Ming Wang, David G. Strauss
Publikováno v:
Clinical Pharmacology & Therapeutics. 113:1030-1035
The US Food and Drug Administration (FDA) Biosimilars Guidance describes how biosimilars may be approved based on clinical pharmacokinetic and pharmacodynamic (PD) biomarker data, without comparative clinical studies with efficacy end points. This ty
Autor:
Sophie Shubow, Qin Sun, Ai Len Nguyen Phan, Dana C. Hammell, Maureen Kane, Gary H. Lyman, Allan Gibofsky, Gary R. Lichtenstein, Zachary Bloomgarden, Raymond K. Cross, Sarah Yim, James E. Polli, Yow‐Ming Wang
Publikováno v:
Clinical Pharmacology & Therapeutics. 113:37-49
The approval and adoption of biosimilar products are essential to contain increasing healthcare costs and provide more affordable choices for patients. Despite steady progress in the number of the US Food and Drug Administration (FDA) biosimilar appr
Publikováno v:
Clinical Pharmacology & Therapeutics. 113:55-61
A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from a US Food and Drug Administration (FDA)-approved reference product. The development and approval of biosimilars is critical to enhancing
Autor:
Sarah Hersey, Steve Keller, Joel Mathews, Lindsay King, Abbas Bandukwala, Flora Berisha, Mary Birchler, Joe Bower, Valerie Clausen, Jose Duarte, Fabio Garofolo, Shirley Hopper, Sumit Kar, Omar Mabrouk, Jean-Claude Marshall, Kristina McGuire, Michael Naughton, Yoshiro Saito, Imelda Schuhmann, Gizette Sperinde, Priscila Teixeira, Alessandra Vitaliti, Yow-Ming Wang, Richard Wnek, Yan Zhang, Sue Spitz, Vilma Decman, Steven Eck, Jose Estevam, Polina Goihberg, Enrique Gómez Alcaide, Christèle Gonneau, Michael Nathan Hedrick, Gregory Hopkins, Fabian Junker, Sandra Nuti, Ulrike Sommer, Nathan Standifer, Chad Stevens, Erin Stevens, Carrie Hendricks, Meenu Wadhwa, Albert Torri, Mark Ma, Shannon Harris, Seema Kumar, Michael A Partridge, Teresa Caiazzo, Shannon Chilewski, Isabelle Cludts, Kelly Coble, Boris Gorovits, Christine Grimaldi, Gregor Jordan, John Kamerud, Beth Leary, Meina Liang, Hanjo Lim, Andrew Mayer, Ellen O'Connor, Nisha Palackal, Johann Poetzl, Sandra Prior, Mohsen Rajabi Abhari, Natasha Savoie, Catherine Soo, Mark Ware, Bonnie Wu, Yang Xu, Tong-Yuan Yang, Jad Zoghbi
Publikováno v:
Bioanalysis. 14:627-692
The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on 27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an overwhelmingly high number of nearly 900 professionals representing ph
Autor:
Surinder Kaur, Stephen C Alley, Matt Szapacs, Amanda Wilson, Eugene Ciccimaro, Dian Su, Neil Henderson, Linzhi Chen, Fabio Garofolo, Shawna Hengel, Wenying Jian, John F Kellie, Anita Lee, John Mehl, Joe Palandra, Haibo Qiu, Natasha Savoie, Diaa Shakleya, Ludovicus Staelens, Hiroshi Sugimoto, Giane Sumner, Jan Welink, Robert Wheller, Y-J Xue, Jianing Zeng, Jinhui Zhang, Huiyu Zhou, Jian Wang, Scott Summerfield, Olga Kavetska, Lieve Dillen, Ragu Ramanathan, Mike Baratta, Arindam Dasgupta, Anna Edmison, Luca Ferrari, Sally Fischer, Daniela Fraier, Sam Haidar, Kathrin Heermeier, Christopher James, Allena Ji, Lina Luo, Gustavo Mendes Lima Santos, Noah Post, Anton I Rosenbaum, Sune Sporring, Sekhar Surapaneni, Stephen Vinter, Katty Wan, Eric Woolf, Seongeun (Julia) Cho, Elham Kossary, Sandra Prior, Mohsen Rajabi Abhari, Catherine Soo, Yow-Ming Wang, Abbas Bandukwala, Elana Cherry, Isabelle Cludts, Soma Ghosh, Shirley Hopper, Akiko Ishii-Watabe, Susan Kirshner, Kevin Maher, Kimberly Maxfield, Joao Pedras-Vasconcelos, Yoshiro Saito, Dean Smith, Therese Solstad, Daniela Verthelyi, Meenu Wadhwa, Leslie Wagner, Günter Waxenecker, Haoheng Yan, Lucia Zhang
Publikováno v:
Bioanalysis. 14:505-580
The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on 27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an overwhelmingly high number of nearly 900 professionals representing ph
Autor:
Paula L. Hyland, Lakshmi Manasa S. Chekka, Deepti P. Samarth, Barry A. Rosenzweig, Erica Decker, Esraa G. Mohamed, Yan Guo, Murali K. Matta, Qin Sun, William Wheeler, Carlos Sanabria, James L. Weaver, Sarah J. Schrieber, Jeffry Florian, Yow‐Ming Wang, David G. Strauss
Publikováno v:
Clinical pharmacology and therapeutics. 113(1)
Proteomics has the potential to identify pharmacodynamic (PD) biomarkers for similarity assessment of proposed biosimilars without relying on clinical efficacy end points. In this study, with 36 healthy participants randomized to therapeutic doses of
Autor:
Victoria Gershuny, Qin Sun, Sarah J. Schrieber, Murali K. Matta, James L. Weaver, Ping Ji, Morasa Sheikhy, Cheng‐Hui Hsiao, Giri Vegesna, Aanchal Shah, Kristin Prentice, Jennifer Deering, Yow‐Ming Wang, David G. Strauss, Jeffry Florian
Publikováno v:
Clinical pharmacology and therapeutics. 113(1)
The US Food and Drug Administration (FDA) guidance describes how pharmacodynamic (PD) biomarkers can be used to address residual uncertainty and demonstrate no clinically meaningful differences between a proposed biosimilar and its reference product
Autor:
Morasa Sheikhy, Sarah J. Schrieber, Qin Sun, Victoria Gershuny, Murali K. Matta, Jane P.F. Bai, Xiulian Du, Giri Vegesna, Aanchal Shah, Kristin Prentice, Colleen Nalepinski, Issam Zineh, Yow‐Ming Wang, David G. Strauss, Jeffry Florian
Publikováno v:
Clinical pharmacology and therapeutics.
US Food and Drug Administration (FDA) guidance outlines how biosimilars can be developed based on pharmacokinetic (PK) and pharmacodynamic (PD) similarity study data in lieu of a comparative clinical efficacy study. There is a paucity of PD comparabi