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Diaá M. Shakleya

us food and drug administration

27H-index
70Paper Count
1.8KCitation Count
Published Papers 30
Publication Date
Development of an In Vitro Permeation Test Framework For Naloxone Hydrochloride Intranasal Spray: Establishing IVIVR for Bioequivalence Assessment
err2026-07-30
err0
PREAI
errTasmin Ara Sultana; Manar Al-Ghabeish; Steven Chopski; Ross Walenga; Diaa Shakleya; Bryan Newman; Muhammad Ashraf; Ahmed Zidan
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Process-dependent N-nitroso-ketamine formation during ketamine active pharmaceutical ingredient manufacturing: part I impact of process design, solvent selection, and activated carbon
err2026-07-01
err0
PREAI
errZou, Guozhang; Wang, Hairong; Lupitskyy, Robert; Gu, Jianghong; Johnson, Deborah; Shakleya, Diaa; Xu, Xiaoming; Faustino, Patrick
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Simulation of nitrosamine drug substance-related impurities from secondary amine-related impurities in approved human drug products
err2026-05-20
err0
PREAI
errXiang Yu; Jingyue Yang; Ee-Sunn Chia; Tyler Peryea; Dan Berger; Matthew Vera; Tim Marzan; Yen Vu; Diaa Shakleya; David Keire; Andre Raw
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2025 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)
err2026-02-01
err1
PREAI
errWojcik, 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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Nitrosamine mitigation: NDMA impurity formation and its inhibition in metformin hydrochloride tablets
err2024-12-01
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PREAI
errShakleya, 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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Antioxidants had No Effects on the In-Vitro Permeability of BCS III Model Drug Substances
err2024-09-01
err0
PREAI
errLu, 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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Bumetanide as a Model NDSRI Substrate: N-nitrosobumetanide Impurity Formation and its Inhibition in Bumetanide Tablets
err2023-12-01
err10
PREAI
errShakleya, 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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Rapid Quantitation of Four Nitrosamine Impurities in Angiotensin Receptor Blocker Drug Substances
err2023-05-01
err13
PREAI
errZhang, Jinhui; Selaya, Susan Daniela; Shakleya, Diaa; Mohammad, Adil; Faustino, Patrick J.
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Influence of residual solvents on the physical properties of transdermal drug delivery systems
err2020-10-01
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PREAI
errMazumder, Sonal; Shakleya, Diaa; Mattson, Sara; Ashraf, Muhammad; Faustino, Patrick; Pavurala, Naresh
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Effects of excipients and curing process on the abuse deterrent properties of directly compressed tablets
err2017-01-01
err35
PREAI
errRahman, Ziyaur; Zidan, Ahmed S.; Korang-Yeboah, Maxwell; Yang, Yang; Siddiqui, Akhtar; Shakleya, Diaa; Khan, Mansoor A.; Cruz, Celia; Ashraf, Muhammad
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Acute Nicotine Differentially Impacts Anticipatory Valence- and Magnitude-Related Striatal Activity
err2013-02-01
err50
errOAAI
errRose, Emma Jane; Ross, Thomas J.; Salmeron, Betty Jo; Lee, Mary; Shakleya, Diaa M.; Huestis, Marilyn A.; Stein, Elliot A.
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Combination of intratumoral regulated IL-12 gene delivery and systemic chemotherapy with Palifosfamide (IPM-Tris) enhances anti-tumor effects in breast cancer (4T1) model
err2012-04-01
err0
PREAI
errMurugesan, 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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Chronic Exposure to Nicotine Is Associated with Reduced Reward-Related Activity in the Striatum but not the Midbrain
err2012-02-01
err58
errOAAI
errRose, Emma Jane; Ross, Thomas J.; Salmeron, Betty Jo; Lee, Mary; Shakleya, Diaa M.; Huestis, Marilyn; Stein, Elliot A.
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Relative performance of common biochemical indicators in detecting cigarette smoking
err2011-05-27
err44
errOAAI
errMarrone, Gina F.; Shakleya, Diaa M.; Scheidweiler, Karl B.; Singleton, Edward G.; Huestis, Marilyn A.; Heishman, Stephen J.
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Maternal Methadone Dose, Placental Methadone Concentrations, and Neonatal Outcomes
err2011-03-01
err45
errOAAI
errde Castro, Ana; Jones, Hendree E.; Johnson, Rolley E.; Gray, Teresa R.; Shakleya, Diaa M.; Huestis, Marilyn A.
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Chronic smoking, but not acute nicotine administration, modulates neural correlates of working memory
err2010-09-23
err36
errOAAI
errSutherland, Matthew T.; Ross, Thomas J.; Shakleya, DiaaM.; Huestis, Marilyn A.; Stein, Elliot A.
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