Estimating Efficacy and Drug ED50's Using von Frey Thresholds: Impact of Weber's Law and Log Transformation von Mills, Charles, LeBlond, David, Joshi, Shailen, Zhu, Chang, Hsieh, Gin, Jacobson, Peer, Meyer, Michael, Decker, Michael

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Increased serum clearance of oligomannose species present on a human IgG1 molecule von Alessandri, Leslie, Ouellette, David, Acquah, Aima, Rieser, Mathew, LeBlond, David, Saltarelli, Mary, Radziejewski, Czeslaw, Fujimori, Taro, Correia, Ivan

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Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry von Burdick, Richard K

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Risk-Based Approach to Lot Release von Mockus, Linas, Reklaitis, Gintaras, Morris, Kenneth, LeBlond, David

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In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When—Workshop Summary Report von Suarez-Sharp, Sandra, Abend, Andreas, Hoffelder, Thomas, Leblond, David, Delvadia, Poonam, Kovacs, Elisabeth, Diaz, Dorys Argelia

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Cross Validation of Aerodynamic Shape Optimization Methodologies for Aircraft Wing-Body Optimization von Reist, Thomas A, Koo, David, Zingg, David W, Bochud, Pascal, Castonguay, Patrice, Leblond, David

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The Relationship between Different Assays for Detection and Quantification of Amyloid Beta 42 in Human Cerebrospinal Fluid von Ellis, Teresa A., Li, Jinhe, LeBlond, David, Waring, Jeffrey F.

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DISSOLUTION PROFILE SIMILARITY ANALYSES—STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS von Hoffelder, Thomas, Leblond, David, Van Alstine, Leslie, Diaz, Dorys Argelia, Suarez-Sharp, Sandra, Witkowski, Krista, Altan, Stan, Reynolds, James, Bergeron, Zachary, Lief, Kevin, Zheng, Yanbing, Abend, Andreas

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Bayesian statistical approaches to drug product variability assessment and release von Cai, Qing, Mockus, Linas, LeBlond, David, Sun, Xu, Wei, Hui, Shah, Harsh S., Chaturvedi, Kaushalendra, Sardhara, Rusha, Nahar, Kajalajit, Khalil, Rania, Sharma, Amit, Rutesh, Dave, Joglekar, Girish, Reklaitis, Gintaras, Morris, Kenneth

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Neurodevelopmental Outcomes of Extremely Preterm Infants Fed Donor Milk or Preterm Infant Formula: A Randomized Clinical Trial von Colaizy, Tarah T, Poindexter, Brenda B, McDonald, Scott A, Bell, Edward F, Carlo, Waldemar A, Carlson, Susan J, DeMauro, Sara B, Kennedy, Kathleen A, Nelin, Leif D, Sánchez, Pablo J, Vohr, Betty R, Johnson, Karen J, Herron, Dianne E, Das, Abhik, Crawford, Margaret M, Walsh, Michele C, Higgins, Rosemary D, Stoll, Barbara J, Ambalavanan, Namisavayam, Wyckoff, Myra H, D’Angio, Carl T, Bugg, George W, Ohls, Robin K, Reynolds, Anne Marie, Sokol, Gregory M, Laptook, Abbot R, Olsen, Steven L, White, Jessica R, Jadcherla, Sudarshan R, Bajaj, Monika, Parimi, Prabhu S, Schmidt, Barbara, Laughon, Matthew M, Barks, John, Fisher, Kimberley A, Hibbs, Anna Maria, Peralta-Carcelen, Myriam, Cook, Noah, Heyne, Roy J, Cavanaugh, Brenna, Adams-Chapman, Ira, Fuller, Janell, Hartley-McAndrew, Michelle E, Harmon, Heidi M, Duncan, Andrea F, Hines, Abbey C, Kilbride, Howard W, Richards, Laurie A, Maitre, Nathalie L, Natarajan, Girija, Trembath, Andrea N, Carlson, Martha D, Malcolm, William F, Wilson-Costello, Deanne E

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Umbilical Cord Milking vs Delayed Cord Clamping and Associations with In-Hospital Outcomes among Extremely Premature Infants von Kumbhat, Neha, Eggleston, Barry, DeMauro, Sara B., Van Meurs, Krisa P., Foglia, Elizabeth E., Lakshminrusimha, Satyan, Walsh, Michele C., Watterberg, Kristi L., Wyckoff, Myra H., Das, Abhik, Keszler, Martin, Vieira, Elisa, Truog, William E., Pallotto, Eugenia K., Parimi, Prabhu S., Holmes, Anne, Gaetano, Lisa, Poindexter, Brenda B., Schibler, Kurt, Cotten, C. Michael, Finkle, Joanne, Fisher, Kimberley A., Bose, Gennie, Clark, Cindy, White, Donna, Carlton, David P., Bremer, Andrew A., Higgins, Rosemary D., Sokol, Gregory M., Pedrozza, Claudia, Stephens, Emily K., McDavid, Georgia E., Martin, Karen, Hall, Donna, Wright, Sharon L., Luzader, Patricia, Shadd, Julie C., Stein, Melanie, McCool, Jacqueline, Bann, Carla M., Zaterka-Baxter, Kristin M., Gabrio, Jenna, Leblond, David, Auman, Jeanette O'Donnell, Stevenson, David K., Chock, Valerie Y., Proud, Melinda S., Reichert, Elizabeth N., Carlo, Waldemar A., Ambalavanan, Namasivayam, Collins, Monica V., Cosby, Shirley S., Devaskar, Uday, Chanlaw, Teresa, Bell, Edward F., Colaizy, Tarah T., Ellsbury, Dan L., Walker, Jacky R., Tud, Tracy L., Elenkiwich, Chelsey, Henning, Megan M., Broadbent, Megan, Hogden, Laurie A., Brumbaugh, Jane E., Klein, Jonathan M., Dagle, John M., Fuller, Janell, Hanson, Mary, Kuan, Elizabeth, Eichenwald, Eric C., Schmidt, Barbara, Kirpalani, Haresh, Abbasi, Soraya, Ghavam, Sarvin, D'Angio, Carl T., Guillet, Ronnie, Reynolds, Anne Marie, Wadkins, Holly I.M., Rowan, Mary, Sabaratnam, Premini, Donato, Jennifer, Lakshminrusimha, Satyan, Brion, Luc P., Sepulvida, Pollieanna, Yoder, Bradley A., Baserga, Mariana, Minton, Stephen D., Sheffield, Mark J., Davis, Brandy, Christensen, Susan, Loertscher, Manndi C., Marchant, Trisha, Maxson, Earl, Elmont, Jennifer O., Schaefer, Susan T., Weaver-Lewis, Kimberlee, Natarajan, Girija, Chawla, Sanjay, Childs, Kirsten, Panaitescu, Bogdan

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Social distancing and extremely preterm births in the initial COVID-19 pandemic period von Shukla, Vivek V., Carper, Benjamin A., Ambalavanan, Namasivayam, Rysavy, Matthew A., Bell, Edward F., Das, Abhik, Patel, Ravi M., D’Angio, Carl T., Watterberg, Kristi L., Cotten, C. Michael, Merhar, Stephanie L., Wyckoff, Myra H., Sánchez, Pablo J., Kumbhat, Neha, Carlo, Waldemar A.

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Stability analysis using mixed models: A critique of tolerance interval methods and a probabilistic solution von Altan, Stan, Faya, Paul, Rauk, Adam P., LeBlond, David, Seaman, John W., Banton, Dwaine

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Serum ferritin values in neonates <29 weeks’ gestation are highly variable and do not correlate with reticulocyte hemoglobin content von Bahr, Timothy M., Tan, Sylvia, Smith, Emily, Beauman, Sandra S., Schibler, Kurt R., Grisby, Cathy A., Lowe, Jean R., Bell, Edward F., Laptook, Abbot R., Shankaran, Seetha, Carlton, David P., Rau, Carrie, Baserga, Mariana C., Flibotte, John, Zaterka-Baxter, Kristin, Walsh, Michele C., Das, Abhik, Christensen, Robert D., Ohls, Robin K.

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In Vitro Dissolution Testing: Statistical Approaches and Issues von LeBlond, David

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Duration of noninvasive respiratory support and risk for bronchopulmonary dysplasia or death von Gentle, Samuel J., Carper, Benjamin, Laughon, Matthew M., Jensen, Erik A., Williams, Austin, Travers, Colm P., Ambalavanan, Namasivayam, Lal, Charitharth V., Carlo, Waldemar A.

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Evaluating Current Practices in Shelf Life Estimation von Capen, Robert, Christopher, David, Forenzo, Patrick, Huynh-Ba, Kim, LeBlond, David, Liu, Oscar, O’Neill, John, Patterson, Nate, Quinlan, Michelle, Rajagopalan, Radhika, Schwenke, James, Stroup, Walter

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Testing Assay Linearity Over a Pre-Specified Range von Yang, Harry, Novick, Steven J., LeBlond, David

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Percutaneous vertebroplasty: state of the art von Cotten, A, Boutry, N, Cortet, B, Assaker, R, Demondion, X, Leblond, D, Chastanet, P, Duquesnoy, B, Deramond, H

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Assessment of large-sample unit-dose uniformity tests: the concept of limiting discriminatory thresholds von Hu, Yanhui, LeBlond, David

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