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Robert Lionberger

center for drug evaluation and research
H指数:35
被引数:4,001

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Proceedings of the 2024 FDA-CRCG Workshop: Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products

2024年FDA-CRCG研讨会论文集：评估仿制肽类和寡核苷酸药物产品免疫原性风险的科学与监管考量

The AAPS Journal
IF0
2026-02-120
PRE
Jennifer K. Lee; Ha-Na Lee; Sudhir Agrawal; Joseph A. Balsamo; Andrew Clerman; Sofie Denies; Anne De Groot; Jeremy Fry; Nicolas Gaudenzio; Andrew J. Graves; Kristina E. Howard; SuJin Hwang; Vibha Jawa; Yafei Jin; Logan Kelly-Baker; Emilee Knowlton; Filip Kolenc; Kirthiram Krishnaveni Sivakumar; Jae H. Lee; Yili Li; Likan Liang; Dahui Liu; Yanyan Liu; Robert Lionberger; Markham C. Luke; Mohanraj Manangeeswaran; Mirian Mendoza; Iilun Murphy; Michael Norcross; James E. Polli; Montserrat Puig; Narasimha Rao SP; Hobart Rogers; Anna Schwendeman; Robert Siegel; Sophie Shubow; Noel Smith; Seth G. Thacker; Sophie Tourdot; Kui Yang; Li Zhang; Deyi Zhang; Cameron J. Smith; Eric S. Pang; Daniela Verthelyi
Establishing the suitability of model-integrated evidence to demonstrate bioequivalence for long-acting injectable and implantable drug products: Summary of workshop
CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY
IF3
2023-02-099
OAAI
Gong, Yuqing; Zhang, Peijue; Yoon, Miyoung; Zhu, Hao; Kohojkar, Ameya; Hooker, Andrew C.; Ducharme, Murray P.; Gobburu, Jogarao; Celliere, Geraldine; Gajjar, Parmesh; Li, Bing V.; Velagapudi, Raja; Tsang, Yu Chung; Schwendeman, Anna; Polli, James; Fang, Lanyan; Lionberger, Robert; Zhao, Liang
Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension
AAPS JOURNAL
IF3.7
2019-05-2030
PREAI
Le Merdy, Maxime; Fan, Jianghong; Bolger, Michael B.; Lukacova, Viera; Spires, Jessica; Tsakalozou, Eleftheria; Patel, Vikram; Xu, Lin; Stewart, Sharron; Chockalingam, Ashok; Narayanasamy, Suresh; Rouse, Rodney; Matta, Murali; Babiskin, Andrew; Kozak, Darby; Choi, Stephanie; Zhang, Lei; Lionberger, Robert; Zhao, Liang

研究方向

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Barbara M. Davit
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M
Myong‐Jin Kim
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