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Nidhi Doshi
Nidhi Doshi
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Understanding particle formation: solubility of free fatty acids as polysorbate 20 degradation byproducts in therapeutic monoclonal antibody formulations
N Doshi, B Demeule, S Yadav
Molecular pharmaceutics 12 (11), 3792-3804, 2015
942015
Improving prediction of free fatty acid particle formation in biopharmaceutical drug products: incorporating ester distribution during polysorbate 20 degradation
N Doshi, J Martin, A Tomlinson
Molecular pharmaceutics 17 (11), 4354-4363, 2020
322020
A comprehensive assessment of all-oleate polysorbate 80: free fatty acid particle formation, interfacial protection and oxidative degradation
N Doshi, J Giddings, L Luis, A Wu, K Ritchie, W Liu, W Chan, R Taing, ...
Pharmaceutical research 38, 531-548, 2021
292021
Evaluation of super refined™ polysorbate 20 with respect to polysorbate degradation, particle formation and protein stability
N Doshi, R Fish, K Padilla, S Yadav
Journal of pharmaceutical sciences 109 (10), 2986-2995, 2020
252020
Evaluating a modified high purity polysorbate 20 designed to reduce the risk of free fatty acid particle formation
N Doshi, K Ritchie, T Shobha, J Giddings, K Gregoritza, R Taing, ...
Pharmaceutical Research 38, 1563-1583, 2021
132021
Dissolution of polysorbate 20 degradation related free fatty acid particles in intravenous bag solutions
N Doshi, K Rutherford, A Najjar
Journal of Pharmaceutical Sciences 110 (2), 687-692, 2021
102021
A mechanistic understanding of monoclonal antibody interfacial protection by hydrolytically degraded polysorbate 20 and 80 under IV bag conditions
A Kannan, J Giddings, S Mehta, T Lin, A Tomlinson, K Ritchie, I Shieh, ...
Pharmaceutical Research 39 (3), 563-575, 2022
72022
Impact of silicone oil on free fatty acid particle formation due to Polysorbate 20 degradation
R Fish, J Lin, N Doshi
Pharmaceutical Research 37, 1-15, 2020
72020
Formulation mitigations for particle formation induced by enzymatic hydrolysis of polysorbate 20 in protein-based drug products: insights from a full-factorial longitudinal study
IH Yuk, T Koulis, N Doshi, K Gregoritza, C Hediger, V Lebouc-Haefliger, ...
AAPS Open 8 (1), 18, 2022
52022
Polysorbate Mixtures Having Modified Fatty Acid Ester Distribution
S Yadav, N Doshi, T Shobha, A Tomlinson, A Srivastava
US Patent App. 18/495,374, 2024
2024
Polysorbate mixtures having modified fatty acid ester distribution
S Yadav, N Doshi, T Shobha, A Tomlinson, A Srivastava
US Patent 11,833,206, 2023
2023
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