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收藏A network of regulatory innovations to improve FDA quality assessments of human drug applications
Tran, 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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收藏Effect of Antioxidants in Medicinal Products on Intestinal Drug Transporters
Kulkarni, 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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收藏Biopharmaceutics Applications of Physiologically Based Pharmacokinetic Absorption Modeling and Simulation in Regulatory Submissions to the US Food and Drug Administration for New Drugs基于生理的药代动力学吸收建模和模拟在向美国食品和药物管理局提交的新药监管意见书中的生物药剂学应用
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收藏Dissolution Testing in Drug Product Development: Workshop Summary Report
Abend, 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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收藏Advancing Product Quality: a Summary of the Second FDA/PQRI Conference
Yu, 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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收藏A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion (vol 17, pg 891, 2015)
Jiang, Wenlei; Makhlouf, Fairouz; Schuirmann, Donald J.; Zhang, Xinyuan; Zheng, Nan; Conner, Dale; Yu, Lawrence X.; Lionberger, Robert
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收藏Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference
Yu, 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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