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A Model-Based Approach to Bridging Plasma and Dried Blood Spot Concentration Data for Phase 3 Verubecestat Trials Dockendorf, Marissa F.; Jaworowicz, David; Humphrey, Rebecca; Anderson, Melanie; Breidinger, Sheila; Ma, Lei; Taylor, Theresa; Dupre, Nicole; Jones, Christopher; Furtek, Christine; Kantesaria, Bhavna; Bateman, Kevin P.; Woolf, Eric; Egan, Michael F.; Stone, Julie A. 分享 收藏
An Investigation of Instability in Dried Blood Spot Samples for Pharmacokinetic Sampling in Phase 3 Trials of Verubecestat Anderson, Melanie; Dockendorf, Marissa F.; McIntosh, Ian; Xie, Iris; Breidinger, Sheila; Meng, Dongfang; Ren, Sumei; Zhong, Wendy; Zhang, Li; Roadcap, Brad; Bateman, Kevin P.; Stone, Julie; Woolf, Eric 分享 收藏
Incorporating protein precipitation to resolve hybrid IP-LC-MS assay interference for ultrasensitive quantification of intact therapeutic insulin dimer in human plasma 结合蛋白质沉淀来解决混合ip-lc-ms分析干扰，用于人血浆中完整治疗性胰岛素二聚体的超灵敏定量 Sun, Li; Xu, Yang; Dube, Neal; Anderson, Melanie; Breidinger, Sheila; Vaddady, Pavan; Thornton, Bob; Morrow, Linda; Matthews, Randolph P.; Stoch, S. Aubrey; Woolf, Eric J. 分享 收藏
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Novel Application of the Two-Period Microtracer Approach to Determine Absolute Oral Bioavailability and Fraction Absorbed of Ertugliflozin Raje, Sangeeta; Callegari, Ernesto; Sahasrabudhe, Vaishali; Vaz, Alfin; Shi, Haihong; Fluhler, Eric; Woolf, Eric J.; Schildknegt, Klaas; Matschke, Kyle; Alvey, Christine; Zhou, Susan; Papadopoulos, Dimitris; Fountaine, Robert; Saur, Didier; Terra, Steven G.; Stevens, Lloyd; Gaunt, Daniel; Cutler, David L. 分享 收藏
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Workshop Report: Crystal City V-Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance Booth, Brian; Arnold, Mark E.; DeSilva, Binodh; Amaravadi, Lakshmi; Dudal, Sherri; Fluhler, Eric; Gorovits, Boris; Haidar, Sam H.; Kadavil, John; Lowes, Steve; Nicholson, Robert; Rock, Marie; Skelly, Michael; Stevenson, Lauren; Subramaniam, Sriram; Weiner, Russell; Woolf, Eric 分享 收藏
Implementing Dried Blood Spot Sampling for Clinical Pharmacokinetic Determinations: Considerations from the IQ Consortium Microsampling Working Group Evans, Christopher; Arnold, Mark; Bryan, Peter; Duggan, Jeffrey; James, Christopher A.; Li, Wenkui; Lowes, Steve; Matassa, Luca; Olah, Timothy; Timmerman, Philip; Wang, Xiaomin; Wickremsinhe, Enaksha; Williams, John; Woolf, Eric; Zane, Patricia 分享 收藏
Small Molecule Specific Run Acceptance, Specific Assay Operation, and Chromatographic Run Quality Assessment: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Teams Woolf, Eric J.; McDougall, Stuart; Fast, Douglas M.; Andraus, Maristela; Barfield, Matthew; Blackburn, Michael; Gordon, Ben; Hoffman, David; Inoue, Noriko; Marcelin-Jimenez, Gabriel; Flynn, Amy; LeLacheur, Richard; Reuschel, Scott; Santhanam, Ravisankar; Bennett, Patrick; Duncan, Barbara; Hayes, Roger; Lausecker, Berthold; Sharma, Abhishek; Togashi, Kazutaka; Trivedi, Ravi Kumar; Vago, Miguel; White, Stephen; Barton, Hollie; Dunn, John A.; Farmen, Raymond H.; Heinig, Katja; Holliman, Christopher; Komaba, Junji; Riccio, Maria Francesca; Thomas, Elizabeth 分享 收藏
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Effect of Alendronate and Vitamin D3 on Fractional Calcium Absorption in a Double-Blind, Randomized, Placebo-Controlled Trial in Postmenopausal Osteoporotic Women 在绝经后骨质疏松妇女的双盲，随机，安慰剂对照试验中，阿仑膦酸盐和维生素D3对钙吸收分数的影响 Shapses, Sue A.; Kendler, David L.; Robson, Richard; Hansen, Karen E.; Sherrell, Robert M.; Field, M. Paul; Woolf, Eric; Berd, Yulia; Mantz, Ann Marie; Santora, Arthur C., II 分享 收藏
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