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M

Markham C. Luke

U.S. Food and Drug Administration
H指数:11
被引数:498

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Comparative Use Human Factors Study of a Manual vs. A Partially Automated Pen Injector for GLP-1 Receptor Agonist Delivery

人因工程对比研究：手动笔式注射器与半自动笔式注射器在GLP-1受体激动剂递送中的应用

CLINICAL PHARMACOLOGY & THERAPEUTICS
IF5.5
2026-04-170
PRE
Karthika Natarajan; Andrew Clerman; Jennifer Soosaar; Samantha Sye; Jack Giacomini; Denise S. Conti; Avani Bhalodia; Jason Flint; Somesh Chattopadhyay; Kathryn Hartka; Sung Lieu; Katharine Feibus; Shinae Kim; Rory Klingensmith; Markham C. Luke
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
Improved Dual-Modality Bioequivalence Evaluation of Topical Formulations Within Human Skin Using Stimulated Raman Scattering Microscopy

采用受激拉曼散射显微镜对人皮肤内局部制剂的双模态生物等效性评价的改进

Pharmaceutics 2025, Vol. 17, Page 1193
IF5.5
2025-09-190
OAAI
Dandan Tu; Nick-Sidney Lemberger; Kristin Wallmeier; Jackson Riseman; Benjamin A. Kuzma; Yuxiao Wei; Ting Chean Khoo; Elena Rantou; Priyanka Ghosh; Markham C. Luke; Sam G. Raney; Carsten Fallnich; Conor L. Evans
Scientific and regulatory activities initiated by the US Food and drug administration to foster approvals of generic dry powder inhalers: Bioequivalence perspective
ADVANCED DRUG DELIVERY REVIEWS
IF17.6
2022-11-019
PRE
Newman, Bryan; Babiskin, Andrew; Bielski, Elizabeth; Boc, Susan; Dhapare, Sneha; Fang, Lanyan; Feibus, Katharine; Kaviratna, Anubhav; V. Li, Bing; Luke, Markham C.; Ma, Tian; Spagnola, Michael; Walenga, Ross L.; Wang, Zhong; Zhao, Liang; El-Gendy, Nashwa; Bertha, Craig M.; Abd El-Shafy, Mohammed; Gaglani, Dhaval K.
Scientific and regulatory activities initiated by the US food and drug administration to foster approvals of generic dry powder inhalers: Quality perspective
ADVANCED DRUG DELIVERY REVIEWS
IF17.6
2022-10-018
PRE
El-Gendy, Nashwa; Bertha, Craig M.; Abd El-Shafy, Mohammed; Gaglani, Dhaval K.; Babiskin, Andrew; Bielski, Elizabeth; Boc, Susan; Dhapare, Sneha; Fang, Lanyan; Feibus, Katharine; Kaviratna, Anubhav; Li, Bing V.; Luke, Markham C.; Ma, Tian; Newman, Bryan; Spagnola, Michael; Walenga, Ross L.; Zhao, Liang

研究方向

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L
Liang Zhao
H 指数:30论文数:198被引数:4,502
R
Robert Lionberger
H 指数:35论文数:98被引数:4,026
B
Bryan Newman
H 指数:18论文数:49被引数:2,266
L
Lanyan Fang
H 指数:19论文数:98被引数:1,850
R
Ross Walenga
H 指数:20论文数:67被引数:1,313
E
Elizabeth Bielski
H 指数:11论文数:25被引数:486
M
Myong‐Jin Kim
H 指数:16论文数:117被引数:985
A
Andrew Babiskin
H 指数:0论文数:0被引数:10
S
Sneha Dhapare
H 指数:9论文数:30被引数:203
B
Bing V. Li
H 指数:13论文数:33被引数:491