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Lawrence X. Yu

us food & drug administration (fda)

59H指数
252论文数
1.5W被引数
收录论文 79
发表时间
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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A network of regulatory innovations to improve FDA quality assessments of human drug applications
err2024-06-01
err1
errOAAI
errTran, Russie; Fraser, Grace; Fisher, Adam C.; Lee, Sau L.; Boam, Ashley; Tsinontides, Stelios; Maguire, Jennifer; Yu, Lawrence X.; Rosencrance, Susan; Kozlowski, Steven; Henry, Don
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Effect of Antioxidants in Medicinal Products on Intestinal Drug Transporters
err2024-05-10
err1
errOAAI
errKulkarni, Chetan P.; Yang, Jia; Koleske, Megan L.; Lara, Giovanni; Alam, Khondoker; Raw, Andre; Rege, Bhagwant; Zhao, Liang; Lu, Dongmei; Zhang, Lei; Yu, Lawrence X.; Lionberger, Robert A.; Giacomini, Kathleen M.; Kroetz, Deanna L.; Yee, Sook Wah
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Understanding In Vivo Dissolution of Immediate Release (IR) Solid Oral Drug Products Containing Weak Acid BCS Class 2 (BCS Class 2a) Drugs
err2021-10-26
err7
PREAI
errLi, Min; Zhang, Xinwen; Wu, Di; Anand, Om; Chen, Hansong; Raines, Kimberly; Yu, Lawrence
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Industry 4.0 for pharmaceutical manufacturing: Preparing for the smart factories of the future
err2021-06-01
err154
errOAAI
errArden, N. Sarah; Fisher, Adam C.; Tyner, Katherine; Yu, Lawrence X.; Lee, Sau L.; Kopcha, Michael
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FDA's new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications
err2019-12-01
err33
errOAAI
errYu, Lawrence X.; Raw, Andre; Wu, Larisa; Capacci-Daniel, Christina; Zhang, Ying; Rosencrance, Susan
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Dissolution Testing in Drug Product Development: Workshop Summary Report
err2019-01-28
err21
PREAI
errAbend, Andreas; Curran, David; Kuiper, Jesse; Lu, Xujin; Li, Hanlin; Hermans, Andre; Kotwal, Pramod; Diaz, Dorys A.; Cohen, Michael J.; Zhang, Limin; Stippler, Erika; Drazer, German; Lin, Yiqing; Raines, Kimberly; Yu, Lawrence; Coutant, Carrie A.; Grady, Haiyan; Kraemer, Johannes; Pope-Miksinski, Sarah; Suarez-Sharp, Sandra
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A multiple biomarker assay for quality assessment of botanical drugs using a versatile microfluidic chip
err2017-09-25
err17
errOAAI
errLi, Zhen-Hao; Ai, Ni; Yu, Lawrence X.; Qian, Zhong-Zhi; Cheng, Yi-Yu
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Advancing pharmaceutical quality: An overview of science and research in the US FDA's Office of Pharmaceutical Quality
err2016-12-01
err69
PREAI
errFisher, Adam C.; Lee, Sau L.; Harris, Daniel P.; Buhse, Lucinda; Kozlowski, Steven; Yu, Lawrence; Kopcha, Michael; Woodcock, Janet
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Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development
err2016-09-20
err10
PREAI
errLi, Min; Sander, Sanna; Duan, John; Rosencrance, Susan; Miksinski, Sarah Pope; Yu, Lawrence; Seo, Paul; Rege, Bhagwant
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Advancing Product Quality: a Summary of the Second FDA/PQRI Conference
err2016-02-09
err18
errOAAI
errYu, Lawrence X.; Akseli, Ilgaz; Allen, Barbara; Amidon, Gregory; Bizjak, Tara Gooen; Boam, Ashley; Caulk, Margaret; Doleski, David; Famulare, Joseph; Fisher, Adam C.; Furness, Scott; Hasselbalch, Brian; Havel, Henry; Hoag, Stephen W.; Iser, Robert; Johnson, Bruce D.; Ju, Robert; Katz, Paula; Lacana, Emanuela; Lee, Sau L.; Lostritto, Richard; McNally, Grace; Mehta, Mehul; Mohan, Ganapathy; Nasr, Moheb; Nosal, Roger; Oates, Mary; O'Connor, Thomas; Polli, Jim; Raju, G. K.; Ramanadham, Mahesh; Randazzo, Giuseppe; Rosencrance, Susan; Schwendeman, Anna; Selen, Arzu; Seo, Paul; Shah, Vinod; Sood, Ramesh; Thien, Michael P.; Tong, Tony; Trout, Bernhardt L.; Tyner, Katherine; Vaithiyalingam, Siva; VanTrieste, Martin; Walsh, Fionnuala; Wesdyk, Russell; Woodcock, Janet; Wu, Geoffrey; Wu, Larisa; Yu, Louis; Zezza, Diane
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Gordon L. Amidon: Very Sustained Drug Absorption
err2015-09-01
err1
errOAAI
errDonovan, Maureen D.; Polli, James E.; Langguth, Peter; Tamai, Ikumi; Vig, Balvinder; Yu, Lawrence X.
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FDA pharmaceutical quality oversight
err2015-08-01
err38
PREAI
errYu, Lawrence X.; Woodcock, Janet
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A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion (vol 17, pg 891, 2015)
err2015-05-15
err1
errOAAI
errJiang, Wenlei; Makhlouf, Fairouz; Schuirmann, Donald J.; Zhang, Xinyuan; Zheng, Nan; Conner, Dale; Yu, Lawrence X.; Lionberger, Robert
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A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion
err2015-04-04
err57
errOAAI
errJiang, Wenlei; Makhlouf, Fairouz; Schuirmann, Donald J.; Zhang, Xinyuan; Zheng, Nan; Conner, Dale; Yu, Lawrence X.; Lionberger, Robert
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Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference
err2015-04-04
err7
errOAAI
errYu, Lawrence X.; Baker, Jeffrey; Berlam, Susan C.; Boam, Ashley; Brandreth, E. J.; Buhse, Lucinda; Cosgrove, Thomas; Doleski, David; Ensor, Lynne; Famulare, Joseph; Ganapathy, Mohan; Grampp, Gustavo; Hussong, David; Iser, Robert; Johnston, Gordon; Kesisoglou, Filippos; Khan, Mansoor; Kozlowski, Steven; Lacana, Emanuela; Lee, Sau L.; Miller, Stephen; Miksinski, Sarah Pope; Moore, Christine M. V.; Mullin, Theresa; Raju, G. K.; Raw, Andre; Rosencrance, Susan; Rosolowsky, Mark; Stinavage, Paul; Thomas, Hayden; Wesdyk, Russell; Windisch, Joerg; Vaithiyalingam, Sivakumar
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