Kristina E. Howard - Publications, H-index & Citations

Kristina E. Howard

u.s. food & drug administration

15H指数

38论文数

651被引数

收录论文 18

发表时间

Advancing PEGylated Drug Evaluation: A Novel Approach to Pegfilgrastim Pharmacokinetic Assessment 推进聚乙二醇化药物评估：一种新型培非格拉斯他敏药代动力学评估方法

Clinical and Translational Science

IF2.8

2026-07-08

OAAI

Elizaveta Svyatova; Da Shi; Ankit Shah; Kristina E. Howard

Donor-specific toxicity of copanlisib identified using immune-humanized mice 使用免疫人源化小鼠确定的copanlisib的供体特异性毒性

cancer immunology, immunotherapy

IF0

2026-06-12

OAAI

Robyn E. Becker; Jenny Résiliac; Kathleen L. Gabrielson; Zhuoming Liu; Kristina E. Howard

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

2026-02-12

PREAI

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

Proteomic Identification of Plasma Biomarkers of Response to IL-5 Inhibitor Biologics in Healthy Subjects 血浆中IL-5抑制剂生物制剂应答反应的蛋白质组学鉴定生物标志物

CTS-CLINICAL AND TRANSLATIONAL SCIENCE

IF2.8

2025-11-30

OAAI

Chekka, Lakshmi Manasa S.; Samarth, Deepti P.; Howard, Kristina E.; Guo, Yan; Mohamed, Esraa G.; Decker, Erica; Wheeler, William; Wommack, Joel; Gogain, Joseph; Deering, Jennifer; Schrieber, Sarah J.; Wang, Yow-Ming; Strauss, David G.; Florian, Jeffry; Hyland, Paula L.

New science, drug regulation, and emergent public health issues: The work of FDA's division of applied regulatory science 新科学，药物监管和紧急公共卫生问题: FDA应用监管科学部门的工作

FRONTIERS IN MEDICINE

IF3

2023-01-19

OAAI

Chiu, Kimberly; Racz, Rebecca; Burkhart, Keith; Florian, Jeffry; Ford, Kevin; Iveth Garcia, M.; Geiger, Robert M. M.; Howard, Kristina E. E.; Hyland, Paula L. L.; Ismaiel, Omnia A. A.; Kruhlak, Naomi L. L.; Li, Zhihua; Matta, Murali K. K.; Prentice, Kristin W. W.; Shah, Aanchal; Stavitskaya, Lidiya; Volpe, Donna A. A.; Weaver, James L. L.; Wu, Wendy W. W.; Rouse, Rodney; Strauss, David G. G.

Calibration and Validation of a Mechanistic COVID-19 Model for Translational Quantitative Systems Pharmacology-A Proof-of-Concept Model Development for Remdesivir

CLINICAL PHARMACOLOGY & THERAPEUTICS

IF5.5

2022-06-29

OAAI

Samieegohar, Mohammadreza; Weaver, James L.; Howard, Kristina E.; Chaturbedi, Anik; Mann, John; Han, Xiaomei; Zirkle, Joel; Arabidarrehdor, Ghazal; Rouse, Rodney; Florian, Jeffry; Strauss, David G.; Li, Zhihua

Innovations, challenges, and minimal information for standardization of humanized mice

EMBO MOLECULAR MEDICINE

IF8.3

2020-06-24

OAAI

Stripecke, Renata; Muenz, Christian; Schuringa, Jan Jacob; Bissig, Karl-Dimiter; Soper, Brian; Meeham, Terrence; Yao, Li-Chin; Di Santo, James P.; Brehm, Michael; Rodriguez, Estefania; Wege, Anja Kathrin; Bonnet, Dominique; Guionaud, Silvia; Howard, Kristina E.; Kitchen, Scott; Klein, Florian; Saeb-Parsy, Kourosh; Sam, Johannes; Sharma, Amar Deep; Trumpp, Andreas; Trusolino, Livio; Bult, Carol; Shultz, Leonard

The ELISA Detectability and Potency of Pegfilgrastim Decrease in Physiological Conditions: Key Roles for Aggregation and Individual Variability

SCIENTIFIC REPORTS

IF3.9

2020-02-12

OAAI

Xie, Tao; Fang, Hui; Ouyang, Weiming; Angart, Phillip; Chiang, Meng-Jung; Bhirde, Ashwinkumar A.; Sheikh, Faruk; Lynch, Patrick; Shah, Ankit B.; Patil, Sharadrao M.; Chen, Kang; Shen, Meiyu; Agarabi, Cyrus; Donnelly, Raymond P.; Brorson, Kurt; Schrieber, Sarah J.; Howard, Kristina E.; Rogstad, Sarah M.; Frucht, David M.

Bone marrow-liver-thymus (BLT) immune humanized mice as a model to predict cytokine release syndrome

TRANSLATIONAL RESEARCH

IF5.9

2019-08-01

PREAI

Yan, Hangyi; Semple, Kenrick M.; Gonzalez, Carlos M.; Howard, Kristina E.

Evaluation of a TGN1412 analogue using in vitro assays and two immune humanized mouse models

TOXICOLOGY AND APPLIED PHARMACOLOGY

IF3.4

2019-06-01

PREAI

Yan, Hangyi; Bhagwat, Bhagyashree; Sanden, David; Willingham, Aarron; Tan, Alick; Knapton, Alan D.; Weaver, James L.; Howard, Kristina E.

BLT-Immune Humanized Mice as a Model for Nivolumab-Induced Immune-Mediated Adverse Events: Comparison of the NOG and NOG-EXL Strains

TOXICOLOGICAL SCIENCES

IF4.1

2019-03-08

PREAI

Weaver, James L.; Zadrozny, Leah M.; Gabrielson, Kathleen; Semple, Kenrick M.; Shea, Katherine I.; Howard, Kristina E.

Evaluation of the Ability of Immune Humanized Mice to Demonstrate CD20-Specific Cytotoxicity Induced by Ofatumumab

CTS-CLINICAL AND TRANSLATIONAL SCIENCE

IF2.8

2019-02-27

OAAI

Semple, Kenrick M.; Gonzalez, Carlos M.; Zarr, Melissa; Austin, Jose R.; Patel, Vikram; Howard, Kristina E.

Evaluating the potential of gold, silver, and silica nanoparticles to saturate mononuclear phagocytic system tissues under repeat dosing conditions

PARTICLE AND FIBRE TOXICOLOGY

IF8.2

2017-07-17

OAAI

Weaver, James L.; Tobin, Grainne A.; Ingle, Taylor; Bancos, Simona; Stevens, David; Rouse, Rodney; Howard, Kristina E.; Goodwin, David; Knapton, Alan; Li, Xiaohong; Shea, Katherine; Stewart, Sharron; Xu, Lin; Goering, Peter L.; Zhang, Qin; Howard, Paul C.; Collins, Jessie; Khan, Saeed; Sung, Kidon; Tyner, Katherine M.

Nonclinical evaluation of the potential for mast cell activation by an erythropoietin analog

TOXICOLOGY AND APPLIED PHARMACOLOGY

IF3.4

2015-09-01

PREAI

Weaver, James L.; Boyne, Michael; Pang, Eric; Chimalakonda, Krishna; Howard, Kristina E.

Development and validation of a liquid-chromatography tandem mass spectrometry method to determine in vitro and in vivo histamine release 用于确定体外和体内组胺释放的液相色谱串联质谱方法的开发和验证

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

IF3.1

2015-01-01

PREAI

Chimalakonda, Krishna C.; Pang, Eric; Weaver, James L.; Howard, Kristina E.; Patel, Vikram; Boyne, Michael T., II

Monoclonal antibodies to B and T lymphocyte attenuator (BTLA) have no effect on in vitro B cell proliferation and act to inhibit in vitro T cell proliferation when presented in a cis, but not trans, format relative to the activating stimulus

CLINICAL AND EXPERIMENTAL IMMUNOLOGY

IF3.8

2010-11-16

OAAI

Zhang, M.; Howard, K.; Winters, A.; Steavenson, S.; Anderson, S.; Smelt, S.; Doellgast, G.; Sheelo, C.; Stevens, J.; Kim, H.; Hamburger, A.; Sein, A.; Caughey, D. J.; Lee, F.; Hsu, H.; Siu, G.; Byrne, F. R.

Basal expression levels of IFNAR and Jak-STAT components are determinants of cell-type-specific differences in cardiac antiviral responses

JOURNAL OF VIROLOGY

IF3.8

2007-12-15

OAAI

Zurney, Jennifer; Howard, Kristina E.; Sherry, Barbara

Oral immunization with recombinant Listeria monocytogenes controls virus load after vaginal challenge with feline immunodeficiency virus

JOURNAL OF VIROLOGY

IF3.8

2004-08-01

OAAI

Stevens, R; Howard, KE; Nordone, S; Burkhard, M; Dean, GA

研究方向