Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01FD004275-04
Application #
8713914
Study Section
Special Emphasis Panel (ZFD1)
Project Start
2011-09-21
Project End
2016-08-31
Budget Start
2014-09-01
Budget End
2015-08-31
Support Year
4
Fiscal Year
2014
Total Cost
Indirect Cost
Name
National Institute for Pharm Tech/Education
Department
Type
DUNS #
City
Minneapolis
State
MN
Country
United States
Zip Code
55414
Pisupati, Karthik; Benet, Alexander; Tian, Yuwei et al. (2017) Biosimilarity under stress: A forced degradation study of Remicade® and Remsima™. MAbs 9:1197-1209
Mugheirbi, Naila A; Marsac, Patrick J; Taylor, Lynne S (2017) Insights into Water-Induced Phase Separation in Itraconazole-Hydroxypropylmethyl Cellulose Spin Coated and Spray Dried Dispersions. Mol Pharm 14:4387-4402
Pisupati, Karthik; Tian, Yuwei; Okbazghi, Solomon et al. (2017) A Multidimensional Analytical Comparison of Remicade and the Biosimilar Remsima. Anal Chem 89:4838-4846
Schmitt, Paul D; DeWalt, Emma L; Dow, Ximeng Y et al. (2016) Rapid Discrimination of Polymorphic Crystal Forms by Nonlinear Optical Stokes Ellipsometric Microscopy. Anal Chem 88:5760-8
Vasa, Dipy M; Dalal, Namita; Katz, Jeffrey M et al. (2014) Physical characterization of drug:polymer dispersion behavior in polyethylene glycol 4000 solid dispersions using a suite of complementary analytical techniques. J Pharm Sci 103:2911-2923
Panchal, Jainik; Kotarek, Joseph; Marszal, Ewa et al. (2014) Analyzing subvisible particles in protein drug products: a comparison of dynamic light scattering (DLS) and resonant mass measurement (RMM). AAPS J 16:440-51