Efficacy and safety of intramuscular administration of tixagevimab–cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial

Autor: Abe, Wakana, Adan De Varona, Tania, Adiatullina, Daria, Aguilar Zapata, Daniel, Ahlers, Kevin, Aimo, Carolina, Akere, Ayoade, Akimova, Elena, Alatorre Alexander, Jorge, Aldrich, Logan, Ali Garcia, Ismael, Ali García, Karim, Allison, Lee, Alonso Zuñiga, Rosa, Aloysius, Ivan, Altclas, Javier, Alvarisqueta, Andres, Antila, Martti, Anton, Camila, Árboix Alamo, Elisabet, Arora, Samir, Avilés Felix, Ramón Alejandro, Bakhtina, Natalya, Barbero-Becerra, Varenka, Barragan-Reyes, Armando, Barreira, Alejandro, Barrett, Mitchell, Beran, Jiri, Berki, Nikolett, Berki, Viktoria, Betten, Richard, Binelli, Claudia, Brunzová, Lenka, Bussolari, Cecilia, Byargeon, Karianna, Bytnar, Justyna, Camberos, Carlos, Campos Corzo, Pedro, Cannon, Grazia, Canovi, Valentina, Carla da Rosa, Simone, Moser, Ana Caroline, Carrera Rivas, Luis, Casas, Marcelo Martin, Castañeda-Méndez, Paulo, Cavalcante, Ana, Cherepova, Eugenia, Chermenskii, Alexei, Clark, Lauren, Codeluppi, Mauro, Coelho, Flavia, Contreras, Belinda, Cran, Alex, Dao, Taylor, Dharma, Chrisette, Di Castri, Cosimo, Diaz Balocchi, Victoria, Durán, Omar, Earl, Kara, Ellery, Adam, Endo, Tomoko, Everding, Andrea, Fischer, Rainald, Fonseca, Benedito, Franklin, Chelsea C., Franz, Susan-Beatrice, Fumagalli, Anna, Galindo-Amaya, Mauricio, Galli, Mariagiulia, Gerna, Laura, Gil Ureña, Karolly, Gomes Antila, Henrikki, Gomes Maricato, Laura Ines, Goncalvez, Gabriela, Gonzalez, Martin, González-Lama, Jesús, Granier, Stephen, Granier, Jacob, Grunwald, Stephan, Guardeño-Ropero, David, Guberti, Monica, Guduri, Sridhar, Guerrero García, Carolina, Haggiagi, Jehad, Hale, Kacie, Hayashi, Toshimasa, Hermes, Maiara, Hernandez Colin, Dante, Hirai, Yuji, Hojo, Masayuki, Homma, Tetsuya, Hour, Billy, Huber, Andreas, Iacovelli, Diego, Ishibashi, Noriomi, Iwabe, Yutaro, Izumi, Shinyu, Jessen, Arne, Jessen, Heiko, Jeudy, Wilner, Jiménez Marcos, Marta, Johnson, Rebecca, Juárez-Hernández, Eva, Kabasawa, Kiyomi, Kamińska, Katarzyna, Kawabe, Megumi, Kemp, Angela, Khmelnitskiy, Oleg, Klassen, Carina, Kobrynska, Olena, Koleckar, Pavel, Korn, Stephanie, Kornmann, Marc, Kostenko, Viktor, Kovalchuk, Evgenii, Kovalchuk, Yana, Kümmerle, Tim, Lachmund, Ulrike, Lammersmann, Kerstin, Lastebasse, Flávio, Lattuada, Ivana, Lauer, Felicitas, Lebed, Kyrylo, Lebed, Olga, Lecona-Garcia, Diego, Leoni, Maria Christina, Lima, Marina, Little, Raymond, Little, Holly, Lizardi-Díaz, Andrea, Lobo-Becker, Michele, Luppi, Francesco, Macias, Veronica, Maesaki, Shigefumi, Magnaghi, Cristiano, Mancini, Annalisa, Mazur, Stanisław, Melnikova, Tatiana, Menchaca, Sergio, Menendez-Perez, Ibrahim, Międlar, Ewa, Mizunuma, Shuuichi, Mochalova, Anastasiya, Mohamed, Mihad, Moll, Theresa, Montalvo, Camila, Mottola, Amber, Mück, Birgit, Mussi Brugnolli, Rebeca, Nanda, Akanksha, Neuner, Dörthe, Ngwueke, Agatha, Noe, Sebastian, Novacek, Martin, Nuzzolo-Shihadeh, Laura, Obiekwe, Emeka, Ocampo Gaytán, Isaias G., Ohmagari, Norio, Ohta, Shin, Onyewuchi, Ptuonye, Pankov, Iurii, Pedrosa, Maurício, Peré, Yael, Pereyra, Alejandro, Perez, Eliana, Perez-Alba, Eduardo, Perpiña Lozano, Paloma, Perrei, Tanya, Peterson, Dena, Pierroti, Ligia, Pineda-Cárdenas, Felipe, Plascencia Sanchez, Teresa, Poletti, Camila, Pomaranzi, Chiara, Portes, Lisette, Postel, Nils, Ramirez, Monica, Ramírez, Isabel, Ramirez-Baena, Miguel, Ramjee, Mahadev, Ratti, Giovanna, Reeve, Jackie, Reichert, Petr, Reichertová, Petra, Reyes Garcia, Edgar Alejandro, Ricardo, Celso, Rodríguez Rodríguez, Nicomedes, Roldán Sánchez, Jaun, Romero-Lopez, Matilde, Rosales, Tyrone, Rosales, Harvey, Roshan, Mohamed, Roshan, Simran, Rovere Querini, Patrizia, Rutter, Heather, Sachwani, Sadaf, Sagara, Hironori, Sakai, Jun, Samson, Nina, Sánchez Mijangos, José Héctor, Sánchez, Liliana, Sánchez-González, Ana, Sandford, Micko, Santana, Laura, Santos de Carvalho, Felipe, Sasao, Reiko, Sato, Lubna, Scheuermann, Elizabeth, Schmidt, Olaf, Seki, Masafumi, Shaikh, Safia, Shimada, Daishi, Shinkai, Masaharu, Shinoda, Masahiro, Smith, Jackie, Solorzano, Fernando, Soncini, Silvia, Soregine, Katalin, Sosa, Erica, Sowade, Olalekan, Špinková, Veronika, Staniford, Ruth, Steigemann, Iska, Steiner, Vivien, Strelkov, Vladimir, Suárez Pineda, Cintya R., Suenaga, Hiroki, Suzaki, Shintaro, Swayze, Hannah, Tada, Yuji, Takeshita, Yuichiro, Takiguchi, Yasuo, Tanaka, Akihiko, Tarumoto, Norihito, Tatarintseva, Albina, Taubert, Michelle, Terenya, Elizaveta, Tinoco, César, Tomiyasu, Tomohiro, Torres-Vidal, Gladys, Trejo-Aguiar, Gabriela, Tsushima, Kenji, Tunstall, Emma, Turrà, Caterina, Valdes, Yoandy, Valencia Castro, Nelly, Visconti, Guilherme, Vitali, Giordano, Vutikullird, Apinya, Watti, Jezdancher, Werth, Doreen, Wilson, Cheyanne, Wilson, Philippe, Workman, Amy, Wörle, Pamela, Wyen, Christoph, Yamaguchi, Yoshiko, Yamamoto, Kei, Montgomery, Hugh, Hobbs, F D Richard, Padilla, Francisco, Arbetter, Douglas, Templeton, Alison, Seegobin, Seth, Kim, Kenneth, Campos, Jesus Abraham Simón, Arends, Rosalinda H ^*, Brodek, Bryan H, Brooks, Dennis, Garbes, Pedro, Jimenez, Julieta, Koh, Gavin C K W, Padilla, Kelly W, Streicher, Katie, Viani, Rolando M, Alagappan, Vijay, Pangalos, Menelas N, Esser, Mark T ^*

Publikováno v: In The Lancet Respiratory Medicine October 2022 10(10):985-996

Effect of itraconazole, food, and ethnic origin on the pharmacokinetics of ivosidenib in healthy subjects

Autor: Hua Yang, Chris Bowden, Jeffrey Zacher, David Dai, Samuel V. Agresta, Apinya Vutikullird, Hua Liu, Guowen Liu, Bin Fan, Chandra Prakash, Salah Nabhan, Denice Hickman

Publikováno v: European Journal of Clinical Pharmacology. 75:1099-1108

To assess the effect of ethnicity, food, and itraconazole (strong CYP3A4 inhibitor) on the pharmacokinetics of ivosidenib after single oral doses in healthy subjects. Three phase 1 open-label studies were performed. Study 1: Japanese and Caucasian su

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d716ee07ac416eff28f76c988d36474f
https://doi.org/10.1007/s00228-019-02673-6

A pharmacokinetics phase 1 bioequivalence study of the trastuzumab biosimilar MYL-1401O vs . EU-trastuzumab and US-trastuzumab

Autor: Nilanjan Sengupta, Cornelius F. Waller, Andrew D. Shaw, Charles Donnelly, Mark Liu, Parag Goyal, Rajiv Sharma, Abhijit Barve, Apinya Vutikullird, Mark Baczkowski, Eduardo J. Pennella, Tracey E. Lawrence

Publikováno v: British Journal of Clinical Pharmacology. 84:2336-2343

Aims Trastuzumab is a humanized monoclonal antibody that binds the human epidermal growth factor receptor 2 (HER2) oncoprotein and is an effective therapy for HER2-overexpressing breast cancer. MYL-1401O is a trastuzumab biosimilar. Here, we report r

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::7d392b69b2aa7b257094aa63c103f54c
https://doi.org/10.1111/bcp.13689

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Pharmacokinetics and safety of olopatadine hydrochloride 0.77% in healthy subjects with asymptomatic eyes: data from 2 independent clinical studies

Autor: Kenneth N Sall, Ganesh R Iyer, Apinya Vutikullird, David Wirta, Abhijit Narvekar, Edward John Meier, Harvey Dubiner

Publikováno v: Clinical Ophthalmology (Auckland, N.Z.)

Edward Meier,1 Abhijit Narvekar,2 Ganesh R Iyer,2 Harvey B DuBiner,3 Apinya Vutikullird,4 David Wirta,5 Kenneth Sall61Apex Eye, Mason, OH, 2Alcon Research Ltd., Fort Worth, TX, 3Clayton Eye Center, Morrow,GA, 4WCCT Global, Cypress, 5Eye Research Foun

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f6385959bb0a9638f6ecd4ea5fe48e1e
https://www.dovepress.com/pharmacokinetics-and-safety-of-olopatadine-hydrochloride-077-in-health-peer-reviewed-article-OPTH