Estimating Efficacy and Drug ED50's Using von Frey Thresholds: Impact of Weber's Law and Log Transformation by 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 by Alessandri, Leslie, Ouellette, David, Acquah, Aima, Rieser, Mathew, LeBlond, David, Saltarelli, Mary, Radziejewski, Czeslaw, Fujimori, Taro, Correia, Ivan

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

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

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

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DISSOLUTION PROFILE SIMILARITY ANALYSES—STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS by 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 by 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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The Posterior Probability of Passing a Compendial Standard, Part 1: Uniformity of Dosage Units by LeBlond, David, Mockus, Linas

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Neurodevelopmental Outcomes of Extremely Preterm Infants Fed Donor Milk or Preterm Infant Formula: A Randomized Clinical Trial by 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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AICc for Calibration Model Selection in Assay Validation by Zhang, Lanju, Tan, Charles, LeBlond, David

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Framework of Multiblock Structured Grid Smoothing Algorithms for Aircraft Configurations by Hasanzadeh Lashkajani, Kazem, Laurendeau, Eric, Castonguay, Patrice, Leblond, David

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

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Social distancing and extremely preterm births in the initial COVID-19 pandemic period by 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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Behavior Profiles at 2 Years for Children Born Extremely Preterm with Bronchopulmonary Dysplasia by Bell, Edward F., Grey, Scott F., Vohr, Betty R., Harmon, Heidi M., Logan, J. Wells, Colaizy, Tarah T., Peralta-Carcelen, Myriam A., McGowan, Elisabeth C., Stoll, Barbara J., Caplan, Michael S., Keszler, Martin, Hensman, Angelita M., Vieira, Elisa, Newman, Nancy S., Siner, Bonnie S., Pallotto, Eugenia K., Gauldin, Cheri, Holmes, Anne, Johnson, Kathy, Knutson, Allison, Schibler, Kurt, Gratton, Teresa L., Wuertz, Sandra, Adams-Chapman, Ira, Hale, Ellen C., Bottcher, Diane I., Goldberg, Ronald N., Goldstein, Ricki F., Malcolm, William F., Ashley, Patricia L., Finkle, Joanne, Bernhardt, Janice, Wilson Archer, Stephanie, Papile, Lu Ann, Hines, Abbey C., Gunn, Susan, Smiley, Lucy, Wright, Sharon L., Nelin, Leif D., Luzader, Patricia, Parikh, Nehal A., Newman, Jamie E., Leblond, David, Adams, Marian M., Huffman, Lynne C., Palmquist, Andrew W., Sankar, Meera N., Frantz, Ivan D., Fiascone, John M., Nylen, Ellen, Brussa, Ana K., Whitley, Sally, Garg, Meena, Vaucher, Yvonne E., Demetrio, Clarence, Rich, Wade, Hogden, Laurie A., Broadbent, Megan, Schmelzel, Mendi L., Walker, Jacky R., Watterberg, Kristi L., Ohls, Robin K., Backstrom Lacy, Conra, Fuller, Janell, Hanson, Mary Ruffner, Kuan, Elizabeth, Mancini, Toni, Bernbaum, Judy C., D'Angio, Carl T., Guillet, Ronnie, Lakshminrusimha, Satyan, Sacilowski, Michael G., Hunn, Julianne, Fallone, Cait, Vasil, Diana M., Chen, Lijun, De Leon, Maria M., Madden, Linda A., Sepulveda, Pollieanna, Faix, Roger G., Yoder, Bradley A., Baserga, Mariana, Bird, Karie, Burnett, Jill, Davis, Brandy, Elmont, Jennifer O., Jensen, Jennifer J., Loertscher, Manndi C., Maxson, Earl, Rau, Carrie A., Chawla, Sanjay, Bajaj, Monika, Johnson, Mary E., Wiggins, Stephanie A., Christensen, Mary K., Carlson, Martha, White, Diane F., Jacobs, Harris, Cervone, Patricia, Greisman, Sheila

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Serum ferritin values in neonates <29 weeks' gestation are highly variable and do not correlate with reticulocyte hemoglobin content by 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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FDA Bayesian statistics guidance for Medical Device Clinical Trials--application to process validation by LeBlond, David

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Duration of noninvasive respiratory support and risk for bronchopulmonary dysplasia or death by 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 by 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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Review of the CDRH/CBER Bayesian guidance by LeBlond, David

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

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