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SaveProcess-dependent N-nitroso-ketamine formation during ketamine active pharmaceutical ingredient manufacturing: part I impact of process design, solvent selection, and activated carbon
Zou, Guozhang; Wang, Hairong; Lupitskyy, Robert; Gu, Jianghong; Johnson, Deborah; Shakleya, Diaa; Xu, Xiaoming; Faustino, Patrick
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Save2025 White Paper on Recent Issues in Bioanalysis: What is the Future of Bioanalytical LIMS? AI/ML Integration in Bioanalysis; Tear Sample Collection; Radiolabeled Mass Balance Studies; Chiral Assays; Bioanalysis of Antibody-Oligonucleotide & Bicycle Drug Conjugates (PART 1A-Recommendations on Mass Spectrometry Assays, Chromatography, Sample Preparation and Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting PART 1B-Regulatory Agencies' Input on Regulated Bioanalysis/BMV)
Wojcik, John; Qian, Mark; Rosenbaum, Anton I.; Maes, Estelle; Xue, Yongjun; Kochansky, Christopher; Boer, Jason; Chen, Linzhi; Descloux, Sandrine; Garofolo, Fabio; Johnson, Jay; Kaur, Surinder; Lassman, Michael; Mcgregor, Jessica; O'callaghan, Lisa; Sikorski, Timothy; Wan, Katty; Wang, Shunhai; Zheng, Naiyu; Zhang, Guodong; Hoover, Michael; Wang, Jian; Yuan, Long; Ji, Qin; Jones, Barry; Boyanapalli, Ramakrishna; Chen, Jian; Dobson, Christine; Dong, Linlin; Ferrari, Luca; Fu, Yunlin; Gong, Chao; Ivanova, Dany; Li, Jing; Licea-Perez, Hermes; Liu, Aihua; Tang, Xiaonan; Tao, Lin; Tweed, Joseph; Eddy, John; Francis, Jennifer; Kavetska, Olga; Araya, Marcela; Foley, Timothy; Andisik, Matthew; Belfast, Mary; Borbridge, Lisa; Cho, Seongeun (julia); Colligan, Liliana; Dasgupta, Arindam; Edmison, Anna; Fandozzi, Christine; Galliccia, Fabrizio; Kim, Yeoun Jin; Lu, Yang; Massip, Anne-Marie; Shakleya, Diaa; Tampal, Nilufer; Neto, Joao Tavares; Thomas, Justina; Wang, Jin; Wang, Linna; Wang, Ying; Whale, Emma; Wiberg, Megan; Yang, Li
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SaveNitrosamine mitigation: NDMA impurity formation and its inhibition in metformin hydrochloride tablets
Shakleya, Diaa; Alayoubi, Alaadin; Brown, Dustin; Mokbel, Alaa; Abrigo, Nicolas; Mohammad, Adil; Wang, Jiang; Li, David; Shaklah, Maha; Alsharif, Fahd M.; Desai, Saaniya; Essandoh, Martha; Faustino, Patrick J.; Ashraf, Muhammad; O'Connor, Thomas; Vera, Matthew; Raw, Andre; Sayeed, Vilayat A.; Keire, David
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SaveAntioxidants had No Effects on the In-Vitro Permeability of BCS III Model Drug Substances
Lu, Dongmei; Rege, Bhagwant; Raw, Andre; Yang, Jingyue; Alam, Khondoker; Bode, Chris; Zhao, Liang; Faustino, Patrick; Wu, Fang; Shakleya, Diaa; Nickum, Elisa; Li, Bing V.; Wang, Rong; Stier, Ethan; Miezeiewski, Blair; Patel, Rachana; Boam, Ashley; Lionberger, Robert; Keire, David; Yu, Lawrence
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SaveBumetanide as a Model NDSRI Substrate: N-nitrosobumetanide Impurity Formation and its Inhibition in Bumetanide Tablets
Shakleya, Diaa; Asmelash, Bethel; Alayoubi, Alaadin; Abrigo, Nicolas; Mohammad, Adil; Wang, Jiang; Zhang, Jinhui; Yang, Jingyue; Marzan, Tim Andres; Li, David; Shaklah, Maha; Alsharif, Fahd M.; Desai, Saaniya; Faustino, Patrick J.; Ashraf, Muhammad; O'Connor, Thomas; Vera, Matthew; Raw, Andre; Sayeed, Vilayat A.; Keire, David
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SaveCombination of intratumoral regulated IL-12 gene delivery and systemic chemotherapy with Palifosfamide (IPM-Tris) enhances anti-tumor effects in breast cancer (4T1) model
Murugesan, Selva; Fogler, William; Valacer, David; Youssoufian, Hagop; Morgan, Robert A.; Herberman, Ronald; Connelly, Shelia; Hart, Susan E.; Bharathan, Mini; Chan, Timothy; Shakleya, Diaa; Moreno, Mario; Barrett, John A.
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