REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19 von Weinreich, David M, Sivapalasingam, Sumathi, Norton, Thomas, Ali, Shazia, Gao, Haitao, Bhore, Rafia, Xiao, Jing, Hooper, Andrea T, Hamilton, Jennifer D, Musser, Bret J, Rofail, Diana, Hussein, Mohamed, Im, Joseph, Atmodjo, Dominique Y, Perry, Christina, Pan, Cynthia, Mahmood, Adnan, Hosain, Romana, Davis, John D, Turner, Kenneth C, Baum, Alina, Kyratsous, Christos A, Kim, Yunji, Cook, Amanda, Kampman, Wendy, Roque-Guerrero, Lilia, Acloque, Gerard, Aazami, Hessam, Cannon, Kevin, Simón-Campos, J. Abraham, Bocchini, Joseph A, Kowal, Bari, DiCioccio, A. Thomas, Soo, Yuhwen, Geba, Gregory P, Stahl, Neil, Lipsich, Leah, Braunstein, Ned, Herman, Gary, Yancopoulos, George D

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A pharmacokinetics (PK) bioequivalence trial of proposed trastuzumab biosimilar, Myl-1401O (A) vs EU-Herceptin (B) and US-Herceptin (C) von Waller, C, Vutikullird, A, Lawrence, T, Shaw, A, Liu, M.S, Baczkowski, M, Sharma, R, Barve, A, Pennella, E

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Safety and immunogenicity of mRNA-1345 RSV vaccine coadministered with an influenza or COVID-19 vaccine in adults aged 50 years or older: an observer-blinded, placebo-controlled, r... von Cardona, Jose F, Hsu, Denise C, Simorellis, Alana K, Wilson, Lauren, Dhar, Rakesh, Tomassini, Joanne E, Wang, Xiaowei, Kapoor, Archana, Righi, Vinicius, Lan, Lan, Du, Jiejun, Zhou, Honghong, Stoszek, Sonia K, Shaw, Christine A, Reuter, Caroline, Wilson, Eleanor, Miller, Jacqueline M, Das, Rituparna, Akinsola, Adebayo, Anderson, Rachel, Aymar, Summer, Bell, Robert, Berman, Gary, Bernard, David, Bradley, Paul, Brosz, Adam, Cardona, Jose, Carlson, Mark, Caso, Jorge, Chu, Laurence, Clarke, Natalie, De La Cruz, Luis, DeAtkine, David, Downey, Jackson, Eagerton, Donald, Elsaadi, Bachar, Ensz, David, Espinosa-Fernandez, Ivette, Essink, Brandon, Fitz-Patrick, David, Kalen, Vicki, Kennelly, Christina, Kutner, Mark, Logan, Douglas, Lorch, Daniel, Meyer, Jay, Navarro, Martha, Patel, Rahul, Patel, Suchet, Reyes, Leonel, Siddiqui, Farhan, Soufer, Joseph, Thompson, Charles, Akinsola, Adebayo, Amin, Faisal, Anderson, Rachel, Aymar, Summer, Beckes, John, Bell, Robert, Berman, Gary, Blad, Kennet, Bradley, Paul, Brosz, Adam, Cardona, Jose, Carlson, Mark, Chu, Laurence, Clarke, Natalie, De La Cruz, Luis, Downey, Jackson, Eagerton, Donald, Ensz, David, Espinosa-Fernandez, Ivette, Essink, Brandon, Fussell, Suzanne, Harper, Charles, Heller, Barry, Jenders, Robert, Kennelly, Christina, Kleiner, Mark, Kutner, Mark, Marquez-Mendoza, Otto, Morris, Jason, Myneni, Banu, Navarro, Martha, Paliwal, Amit, Parikh, Naresh, Patel, Rahul, Patel, Suchet, Pearce, Katherine, Pervaiz, Syed, Peterson, Bryce, Peterson, Michael, Pirani, Aziz, Reyes, Leone, Sanchez, William, Siddiqui, Farhan, Soufer, Joseph, Thompson, Charles, Vutikullird, Apinya, Ward, Derrick

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253 - A pharmacokinetics (PK) bioequivalence trial of proposed trastuzumab biosimilar, Myl-1401O (A) vs EU-Herceptin (B) and US-Herceptin (C) von Waller, C., Vutikullird, A., Lawrence, T., Shaw, A., Liu, M.S., Baczkowski, M., Sharma, R., Barve, A., Pennella, E.

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Pharmacokinetics and safety of olopatadine hydrochloride 0.77% in healthy subjects with asymptomatic eyes: data from 2 independent clinical studies von Meier, Edward, Narvekar, Abhijit, Iyer, Ganesh R, DuBiner, Harvey B, Vutikullird, Apinya, Wirta, David, Sall, Kenneth

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Efficacy and safety of intramuscular administration of tixagevimab–cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-cont... von Hobbs, F D Richard, Seegobin, Seth, Jimenez, Julieta, Viani, Rolando M, Abe, Wakana, Adiatullina, Daria, Aguilar Zapata, Daniel, Akimova, Elena, Aldrich, Logan, Altclas, Javier, Alvarisqueta, Andres, Antila, Martti, Bakhtina, Natalya, Barbero-Becerra, Varenka, Barragan-Reyes, Armando, Barrett, Mitchell, Berki, Viktoria, Betten, Richard, Binelli, Claudia, Bussolari, Cecilia, Cannon, Grazia, Canovi, Valentina, Carla da Rosa, Simone, Castañeda-Méndez, Paulo, Cherepova, Eugenia, Earl, Kara, Fischer, Rainald, Franz, Susan-Beatrice, Fumagalli, Anna, Galli, Mariagiulia, Gomes Maricato, Laura Ines, Goncalvez, Gabriela, González-Lama, Jesús, Granier, Stephen, Grunwald, Stephan, Guduri, Sridhar, Guerrero García, Carolina, Hale, Kacie, Hayashi, Toshimasa, Hernandez Colin, Dante, Ishibashi, Noriomi, Iwabe, Yutaro, Izumi, Shinyu, Jeudy, Wilner, Kemp, Angela, Khmelnitskiy, Oleg, Kobrynska, Olena, Koleckar, Pavel, Kovalchuk, Evgenii, Lastebasse, Flávio, Lattuada, Ivana, Lebed, Kyrylo, Little, Raymond, Menchaca, Sergio, Moll, Theresa, Montalvo, Camila, Neuner, Dörthe, Novacek, Martin, Nuzzolo-Shihadeh, Laura, Obiekwe, Emeka, Ohmagari, Norio, Pankov, Iurii, Pereyra, Alejandro, Perrei, Tanya, Pierroti, Ligia, Pineda-Cárdenas, Felipe, Ramirez, Monica, Ramirez-Baena, Miguel, Reeve, Jackie, Reichert, Petr, Reichertová, Petra, Reyes Garcia, Edgar Alejandro, Rosales, Harvey, Rovere Querini, Patrizia, Rutter, Heather, Sakai, Jun, Sánchez, Liliana, Sánchez-González, Ana, Santana, Laura, Sasao, Reiko, Seki, Masafumi, Shinkai, Masaharu, Shinoda, Masahiro, Soregine, Katalin, Špinková, Veronika, Staniford, Ruth, Steigemann, Iska, Strelkov, Vladimir, Tanaka, Akihiko, Tatarintseva, Albina, Taubert, Michelle, Tomiyasu, Tomohiro, Tunstall, Emma, Valdes, Yoandy, Watti, Jezdancher, Werth, Doreen, Workman, Amy, Wörle, Pamela, Wyen, Christoph, Yamamoto, Kei

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Effect of itraconazole, food, and ethnic origin on the pharmacokinetics of ivosidenib in healthy subjects von Dai, David, Yang, Hua, Nabhan, Salah, Liu, Hua, Hickman, Denice, Liu, Guowen, Zacher, Jeffrey, Vutikullird, Apinya, Prakash, Chandra, Agresta, Samuel, Bowden, Chris, Fan, Bin

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Safety and pharmacokinetic profiles of phosphorodiamidate morpholino oligomers with activity against ebola virus and marburg virus: results of two single-ascending-dose studies von Heald, Alison E, Iversen, Patrick L, Saoud, Jay B, Sazani, Peter, Charleston, Jay S, Axtelle, Tim, Wong, Michael, Smith, William B, Vutikullird, Apinya, Kaye, Edward

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Randomized, Placebo-Controlled, Single-Ascending-Dose Study of BMS-791325, a Hepatitis C Virus (HCV) NS5B Polymerase Inhibitor, in HCV Genotype 1 Infection von SIMS, Karen D, LEMM, Julie, PASUINELLI, Claudio, GRASELA, Dennis M, ELEY, Timothy, MENPING LIU, BERGLIND, Anna, SHERMAN, Diane, LAWITZ, Eric, VUTIKULLIRD, Apinya B, TEBAS, Pablo, MIN GAO

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A Multi-Center, Open-Label, Pharmacokinetic Drug Interaction Study of Erenumab and a Combined Oral Contraceptive in Healthy Females von Xu, Yang, Gabriel, Kristin, Wang, Yi, Zhou, Yanchen, Eisele, Osaro, Vutikullird, Apinya, Mikol, Daniel D., Lee, Edward

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Multiple ascending dose study of BMS‐790052, a nonstructural protein 5A replication complex inhibitor, in patients infected with hepatitis C virus genotype 1 von Nettles, Richard E., Gao, Min, Bifano, Marc, Chung, Ellen, Persson, Anna, Marbury, Thomas C., Goldwater, Ronald, DeMicco, Michael P., Rodriguez‐Torres, Maribel, Vutikullird, Apinya, Fuentes, Ernesto, Lawitz, Eric, Lopez‐Talavera, Juan Carlos, Grasela, Dennis M.

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A pharmacokinetics phase 1 bioequivalence study of the trastuzumab biosimilar MYL‐1401O vs. EU‐trastuzumab and US‐trastuzumab von Waller, Cornelius F., Vutikullird, Apinya, Lawrence, Tracey E., Shaw, Andrew, Liu, Mark Shiyao, Baczkowski, Mark, Sharma, Rajiv, Barve, Abhijit, Goyal, Parag, Donnelly, Charles, Sengupta, Nilanjan, Pennella, Eduardo J.

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Correction to: A Multi‑Center, Open‑Label, Pharmacokinetic Drug Interaction Study of Erenumab and a Combined Oral Contraceptive in Healthy Females von Xu, Yang, Gabriel, Kristin, Wang, Yi, Zhou, Yanchen, Eisele, Osaro, Vutikullird, Apinya, Mikol, Daniel D., Lee, Edward

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Pharmacokinetics, Safety, and Tolerability of a New Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate Diskus(®) in Healthy Adults von Vutikullird, Apinya Bee, Gillespie, Michael, Song, Sharon, Steinfeld, Jonathan

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Pharmacokinetics, Safety, and Tolerability of a New Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate Diskus registered in Healthy Adults von Vutikullird, Apinya Bee, Gillespie, Michael, Song, Sharon, Steinfeld, Jonathan

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A pharmacokinetics (PK) bioequivalence trial of proposed trastuzumab biosimilar, Myl-1401O (A) vs EU-Herceptin (B) and US-Herceptin (C) von Waller, Cornelius F., Vutikullird, Apinya, Lawrence, Tracey E., Shaw, Andrew, Liu, Mark Shiyao, Baczkowski, Mark, Sharma, Rajiv, Barve, Abhijit, Pennella, Eduardo J.

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Pharmacokinetics and Safety of Single Intravenous Doses of JNJ-54452840, an Anti-β1-Adrenergic Receptor Antibody Cyclopeptide, in Healthy Male Japanese and Caucasian Participants von Nnane, Ivo P., Plotnikov, Alexei H., Peters, Gary, Johnson, Maureen, Kojak, Clare, Vutikullird, Apinya, Ariyawansa, Jay, De Vries, Ronald, Davies, Brian E.

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Pharmacokinetics and Safety of Single Intravenous Doses of JNJ-54452840, an Anti-[Beta]1-Adrenergic Receptor Antibody Cyclopeptide, in Healthy Male Japanese and Caucasian Participa... von Nnane, Ivo P, Plotnikov, Alexei H, Peters, Gary, Johnson, Maureen, Kojak, Clare, Vutikullird, Apinya, Ariyawansa, Jay, De Vries, Ronald, Davies, Brian E

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Virologic Efficacy of Casirivimab and Imdevimab COVID-19 Antibody Combination in Outpatients With SARS-CoV-2 Infection: A Phase 2 Dose-Ranging Randomized Clinical Trial von Portal-Celhay, Cynthia, Forleo-Neto, Eduardo, Eagan, Will, Musser, Bret J., Davis, John D., Turner, Kenneth C., Norton, Thomas, Hooper, Andrea T., Hamilton, Jennifer D., Pan, Cynthia, Mahmood, Adnan, Baum, Alina, Kyratsous, Christos A., Kim, Yunji, Parrino, Janie, Kampman, Wendy, Roque-Guerrero, Lilia, Stoici, Roxana, Fatakia, Adil, Soo, Yuhwen, Geba, Gregory P., Kowal, Bari, DiCioccio, A. Thomas, Stahl, Neil, Lipsich, Leah, Braunstein, Ned, Herman, Gary A., Yancopoulos, George D., Weinreich, David M., Altamirano, Dario, Ellington, Dickson, Karimjee, Najmuddin, Daudjee, Munib, Laabs, Jessica, Marler, Karen, Calais, Natalee, Sheppard, Zachary, Carroll, Kristy, Kohli, Anita, McIntyre, Vicki, Sachdeva, Yessica, Carney, Ashley, McFarland, Amanda, Gibson, Dina, Ekoko, Victorine, Kim, Kenneth, Ahn, Jason, Paryani, Nayna, Mottola, Amber, Day, Eva, Navarro, Martha, Vutikullird, Apinya, Roque-Guerrero, Lilia, Gomez Ramirez, Ana, Capote, Javier, Paz, Gisel, Patel, Nancy, Patel, Ravikumar, Sattar, Ryan, Seep, Michael, Brown, Celeste, Whatley, Joshua, Levinson, Dennis, Ahmed, Azazuddin, James, Norman, Alvi, Saad, Kuehl, Ann, Koilpillai, Robinson, Cassady, Stephanie, Cox, Jennifer, Torres, Eduardo, Winnie, Michael, Verma, Omesh, Leggett, Richard, Reyes, Ramon, Beck, Keith, Poliquin, Brian, Mussaji, Murtaza, Shah, Jignesh, Eppensteiner, John, Limkakeng, Alexander, Francis, Samuel, Boghara, Haresh, Patel, Sunny, Eichelbaum, Bari, Anderson, Duane, Su, Sean, Akhavan, Alexander, Venglik, Joy, Kirby, Diana, Fedora, Crista, Fakih, Faisal A., Fakih, Faisal M., Alvarado, Fernando, Layish, Daniel, Diaz, Jose, Perez, Andres, Patel, Bhaktasharan, Tarshis, Gary, Stoici, Roxana

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