Physiologically‐based pharmacokinetic modeling of pantoprazole to evaluate the role of CYP2C19 genetic variation and obesity in the pediatric population

Autor: Elizabeth J. Thompson, Angela Jeong, Victória E. Helfer, Valentina Shakhnovich, Andrea Edginton, Stephen J. Balevic, Laura P. James, David N. Collier, Ravinder Anand, Daniel Gonzalez, the Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee

Publikováno v: CPT: Pharmacometrics & Systems Pharmacology, Vol 13, Iss 8, Pp 1394-1408 (2024)

Abstract Pantoprazole is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease, a condition that disproportionately affects children with obesity. Appropriately dosing pantoprazole in children with obesity requires un

Externí odkaz: https://doaj.org/article/4ca30823adfe493396f3130d6019af5f

Pharmacokinetics of hydroxychloroquine in paediatric lupus: data from a novel, direct-to-family clinical trial

Autor: E Schmitt, C Smith, G Schulert, S Canna, A Grom, E Mellins, A Brown, J Smith, A Stevens, M Watson, S Jones, K Stewart, E Baker, A Kemp, T Davis, A Smith, S Jackson, C Williams, K Jones, T Mason, A Hanson, Y Zhao, B Thomas, A Reed, J Jones, J Cooper, T Lee, J Chang, M Holland, S Joshi, L Lim, C Ramírez, A Murphy, K Moore, E Pagano, B ferreira, S Li, P Lee, H Schmeling, K Abulaban, R Agbayani, S Akoghlanian, E Anderson, L Barillas-Arias, K Baszis, M Becker, H Bell-Brunson, H Benham, S Benseler, T Beukelman, H Brunner, H Bukulmez, L Cerracchio, E Chalom, K Chundru, J Dean, F Dedeoglu, V Dempsey, J Drew, B Feldman, P Ferguson, C Fleming, L Franco, I Goh, D Goldsmith, B Gottlieb, T Graham, T Griffin, M Hance, K Hickey, M Hollander, J Hsu, A Huber, C Hung, A Huttenlocher, L Imundo, C Inman, J Jaquith, L Jung, D Kingsbury, K Klein, M Klein-Gitelman, S Kramer, S Lapidus, D Latham, B Malla, M Malloy, A Martyniuk, K McConnell, D McCurdy, C McMullen-Jackson, L Moorthy, E Muscal, J Olson, K Onel, L Ponder, S Prahalad, C Rabinovich, S Ringold, M Riordan, A Robinson, M Rosenkranz, B Rosolowski, N Ruth, K Schikler, H Stapp, R Syed, M Tesher, A Thatayatikom, R Vehe, E von Scheven, D Wahezi, A Watts, J Weiss, J Wagner, S Kim, Y Zhang, L Favier, J Patel, S Morgan, A Jackson, J Stokes, L Marques, Stephen J Balevic, K Hayward, A White, J Nicholas, D Lovell, A Zeft, J Harris, E Lawson, C Moss, N George, M Sutter, A Cooper, M Adams, S Cooper, M Miller, C Black, R Schneider, J Taylor, R Sran, M Oliver, M Twilt, M Tóth, J Walker, M Mitchell, F De Benedetti, N Singer, M Fox, K Kaufman, A Merritt, R Stevenson, J Fuller, M Fitzgerald, A Davis, C Davis, L Henderson, J Woo, S Mohan, H Reid, Y Kimura, L Harel, R Laxer, K McCarthy, I Ferguson, E McCormick, A Hay, M Guzman, E Fox, P Hill, A PARSONS, S McGuire, J Lam, C Sandborg, B Stevens, J Boland, S Ballinger, E MENDOZA, J NOCTON, M Ritter, N Johnson, J Shirley, S Bowman, M Ibarra, S Hong, M Guevara, K James, L Santiago, A Adams, B DONALDSON, M Son, C Kremer, K Schmidt, T Wright, L Cannon, R Nicolai, M Freeman, S Spence, D Levy, J Paredes, K Gerhold, A Insalaco, T O'Brien, W Bernal, E Kessler, C Lin, M Lerman, T Hahn, B O'Brien, Michael Cohen-Wolkowiez, Christoph P Hornik, N Abel, J Aiello, C Alejandro, E Allenspach, R Alperin, M Alpizar, G Amarilyo, W Ambler, S Ardoin, S Armendariz, I Balboni, S Balevic, L Ballenger, N Balmuri, F Barbar-Smiley, M Basiaga, E Beltz, T Bigley, B Binstadt, M Blakley, J Bohnsack, A Boneparth, C Bracaglia, E Brooks, M Brothers, M Buckley, D Bullock, B Cameron, P Carper, V Cartwright, E Cassidy, A Chang-Hoftman, V Chauhan, P Chira, T Chinn, H Clairman, D Co, A Confair, H Conlon, R Connor, C Correll, R Corvalan, D Costanzo, R Cron, L Curiel-Duran, T Curington, M Curry, A Dalrymple, D De Ranieri, M De Guzman, N Delnay, E DeSantis, T Dickson, J Dingle, E Dorsey, S Dover, J Dowling, K Driest, Q Du, K Duarte, D Durkee, E Duverger, J Dvergsten, A Eberhard, M Eckert, K Ede, B Edelheit, C Edens, Y Edgerly, M Elder, B Ervin, S Fadrhonc, C Failing, D Fair, M Falcon, S Federici, J Fennell, R Ferrucho, K Fields, T Finkel, O Flynn, L Fogel, K Fritz, S Froese, R Fuhlbrigge, D Gerstbacher, M Gilbert, M Gillispie-Taylor, E Giverc, C Godiwala, H Goheer, E Gotschlich, A Gotte, C Gracia, S Grevich, J Griswold, P Guittar, M Hager, O Halyabar, E Hammelev, S Haro, O Harry, E Hartigan, J Hausmann, J Heiart, K Hekl, M Henrickson, A Hersh, S Hillyer, L Hiraki, M Hiskey, P Hobday, C Hoffart, M Horwitz, J Huggins, J HuiYuen, J Huntington, G Janow, S Jared, C Justice, A Justiniano, N Karan, U Khalsa, B Kienzle, M Kitcharoensakkul, T Klausmeier, B Kompelien, A Kosikowski, L Kovalick, J Kracker, J Lai, B Lang, B Lapin, A Lasky, L Lentini, S Lieberman, N Ling, M Lingis, M Lo, D Lowman, N Luca, S Lvovich, C Madison, J Madison, S Magni Manzoni, J Maller, M Mannion, C Manos, S Mathus, L McAllister, P McCurdy Stokes, I McHale, A McMonagle, E Meidan, R Mercado, L Michalowski, P Miettunen, D Milojevic, E Mirizio, E Misajon, R Modica, E Morgan Dewitt, T Moussa, V Mruk, R Nadler, B Nahal, K Nanda, N Nasah, L Nassi, S Nativ, M Natter, J Neely, B Nelson, L Newhall, L Ng, P Nigrovic, B Nolan, E Oberle, B Obispo, O Okeke, K O'Neil, A Orandi, M Orlando, S Osei-Onomah, R Oz, A Paller, N Pan, S Panupattanapong, M Pardeo, K Pentakota, P Pepmueller, T Pfeiffer, K Phillippi, D Pires Marafon, R Pooni, S Pratt, S Protopapas, B Puplava, J Quach, M Quinlan-Waters, S Radhakrishna, J Rafko, J Raisian, A Rakestraw, E Ramsay, S Ramsey, R Randell, K Remmel, A Repp, A Reyes, A Richmond, M Riebschleger, M Riskalla, R Rivas-Chacon, E Rodela, M Rodriquez, K Rojas, T Ronis, H Rothermel, D Rothman, E Roth-Wojcicki, K Rouster-Stevens, T Rubinstein, N Saad, S Sabbagh, E Sacco, R Sadun, A Sanni, A Sarkissian, S Savani, L Scalzi, L Schanberg, S Scharnhorst, A Schlefman, K Schollaert-Fitch, T Seay, C Seper, J Shalen, R Sheets, A Shelly, S Shenoi, K Shergill, M Shishov, C Shivers, E Silverman, V Sivaraman, J Sletten, E Smitherman, J Soep, L Spiegel, J Spitznagle, H Srinivasalu, K Steigerwald, Y Sterba Rakovchik, S Stern, C Stingl, M Stoll, E Stringer, S Sule, J Sumner, R Sundel, G Syverson, A Szymanski, S Taber, R Tal, A Tambralli, A Taneja, T Tanner, S Tapani, G Tarshish, S Tarvin, L Tate, A Taxter, M Terry, K Tiffany, T Ting, A Tipp, D Toib, K Torok, C Toruner, H Tory, S Tse, V Tubwell, S Uriguen, T Valcarcel, H Van Mater, L Vannoy, C Varghese, N Vasquez, K Vazzana, K Veiga, J Velez, J Verbsky, G Vilar, N Volpe, S Vora, L Wagner-Weiner, H Waite, H Walters, T Wampler Muskardin, L Waqar, M Waterfield, P Weiser, P Weiss, E Wershba, A Wise, L Woolnough, E Wu, A Yalcindag, M Yee, E Yen, R Yeung, K Yomogida, Q Yu, R Zapata, A Zartoshti, R Zeft, A Zhu, C Zic, Daniel Weiner, Daniel Gonzalez, Rachel Randell, Claire Beard

Publikováno v: Lupus Science and Medicine, Vol 9, Iss 1 (2022)

Objective Determine the pharmacokinetics (PK) and exposure–response of hydroxychloroquine (HCQ) and desethylhydroxychloroquine (DHCQ) in paediatric SLE (pSLE).Methods We conducted an exploratory phase 2, direct-to-family trial. Children enrolled in

Externí odkaz: https://doaj.org/article/20ce5e9cb2a841b29d1ddbfe3a1ed845

Hydroxychloroquine PK and exposure-response in pregnancies with lupus: the importance of adherence for neonatal outcomes

Autor: Amanda M Eudy, Megan E B Clowse, Stephen J Balevic, Christoph P Hornik, Daniel Weiner, Anil R Maharaj, Daniel Gonzalez

Publikováno v: Lupus Science and Medicine, Vol 9, Iss 1 (2022)

Externí odkaz: https://doaj.org/article/1b041fa339c94e1883aacb32e82d37ba

Delivering clinical trials at home: protocol, design and implementation of a direct-to-family paediatric lupus trial

Autor: Laura E Schanberg, S Canna, A Grom, E Mellins, A Brown, S Jones, E Baker, A Kemp, T Davis, S Jackson, K Jones, T Mason, A Hanson, J Jones, J Cooper, T Lee, J Chang, M Holland, S Joshi, L Lim, A Murphy, K Moore, B ferreira, S Li, P Lee, K Abulaban, R Agbayani, S Akoghlanian, E Anderson, L Barillas-Arias, K Baszis, M Becker, H Bell-Brunson, H Benham, S Benseler, T Beukelman, H Brunner, H Bukulmez, L Cerracchio, E Chalom, K Chundru, J Dean, F Dedeoglu, V Dempsey, J Drew, B Feldman, P Ferguson, C Fleming, L Franco, I Goh, D Goldsmith, B Gottlieb, T Graham, T Griffin, M Hance, K Hickey, M Hollander, J Hsu, A Huber, C Hung, A Huttenlocher, L Imundo, C Inman, J Jaquith, L Jung, D Kingsbury, K Klein, M Klein-Gitelman, S Kramer, S Lapidus, D Latham, B Malla, M Malloy, A Martyniuk, K McConnell, D McCurdy, C McMullen-Jackson, L Moorthy, E Muscal, S Kim, L Favier, S Morgan, A Jackson, L Marques, Stephen J Balevic, K Hayward, J Nicholas, D Lovell, J Harris, E Lawson, C Moss, N George, A Cooper, Rachel L Randell, M Adams, S Cooper, M Miller, C Black, M Mitchell, F De Benedetti, M Fox, K Kaufman, A Merritt, J Fuller, M Fitzgerald, A Davis, C Davis, L Henderson, S Mohan, Y Kimura, L Harel, R Laxer, K McCarthy, I Ferguson, E McCormick, A Hay, M Guzman, E Fox, P Hill, S McGuire, J Lam, J Boland, S Ballinger, E MENDOZA, J NOCTON, N Johnson, S Bowman, M Ibarra, S Hong, M Guevara, K James, A Adams, B DONALDSON, C Kremer, L Cannon, R Nicolai, M Freeman, D Levy, K Gerhold, A Insalaco, W Bernal, E Kessler, C Lin, M Lerman, T Hahn, Lindsay Singler, Anthony Cunningham, Michael Cohen-Wolkowiez, Christoph P Hornik, N Abel, J Aiello, C Alejandro, E Allenspach, R Alperin, M Alpizar, G Amarilyo, W Ambler, S Ardoin, S Armendariz, I Balboni, S Balevic, L Ballenger, N Balmuri, F Barbar-Smiley, M Basiaga, E Beltz, T Bigley, B Binstadt, M Blakley, J Bohnsack, A Boneparth, C Bracaglia, E Brooks, M Brothers, M Buckley, D Bullock, B Cameron, P Carper, V Cartwright, E Cassidy, A Chang-Hoftman, V Chauhan, P Chira, T Chinn, H Clairman, D Co, A Confair, H Conlon, R Connor, C Correll, R Corvalan, D Costanzo, R Cron, L Curiel-Duran, T Curington, M Curry, A Dalrymple, D De Ranieri, M De Guzman, N Delnay, E DeSantis, T Dickson, J Dingle, E Dorsey, S Dover, J Dowling, K Driest, Q Du, K Duarte, D Durkee, E Duverger, J Dvergsten, A Eberhard, M Eckert, K Ede, B Edelheit, C Edens, Y Edgerly, M Elder, B Ervin, S Fadrhonc, C Failing, D Fair, M Falcon, S Federici, J Fennell, R Ferrucho, K Fields, T Finkel, O Flynn, L Fogel, K Fritz, S Froese, R Fuhlbrigge, D Gerstbacher, M Gilbert, M Gillispie-Taylor, E Giverc, C Godiwala, H Goheer, E Gotschlich, A Gotte, C Gracia, S Grevich, J Griswold, P Guittar, M Hager, O Halyabar, E Hammelev, S Haro, O Harry, E Hartigan, J Hausmann, J Heiart, K Hekl, M Henrickson, A Hersh, S Hillyer, L Hiraki, M Hiskey, P Hobday, C Hoffart, M Horwitz, J Huggins, J HuiYuen, J Huntington, G Janow, S Jared, C Justice, A Justiniano, N Karan, U Khalsa, B Kienzle, M Kitcharoensakkul, T Klausmeier, B Kompelien, A Kosikowski, L Kovalick, J Kracker, J Lai, B Lang, B Lapin, A Lasky, L Lentini, S Lieberman, N Ling, M Lingis, M Lo, D Lowman, N Luca, S Lvovich, C Madison, J Madison, S Magni Manzoni, J Maller, M Mannion, C Manos, S Mathus, L McAllister, P McCurdy Stokes, I McHale, A McMonagle, E Meidan, R Mercado, L Michalowski, P Miettunen, D Milojevic, E Mirizio, E Misajon, R Modica, E Morgan Dewitt, T Moussa, V Mruk, R Nadler, B Nahal, K Nanda, N Nasah, L Nassi, S Nativ, M Natter, J Neely, B Nelson, L Newhall, L Ng, P Nigrovic, B Nolan, E Oberle, B Obispo

Publikováno v: Lupus Science and Medicine, Vol 8, Iss 1 (2021)

Introduction Direct-to-family clinical trials efficiently provide data while reducing the participation burden for children and their families. Although these trials can offer significant advantages over traditional clinical trials, the process of de

Externí odkaz: https://doaj.org/article/d5bbec628c144a6fa00bd7aea695791b

Precision Medicine

Autor: Stephen J. Balevic, Anna Carmela P Sagcal-Gironella

Publikováno v: Rheumatic Disease Clinics of North America. 48:305-330

Despite an increase in the number of available therapeutics, many children with rheumatic disease continue to experience active inflammatory disease and treatment failure. One reason for treatment failure is the lack of dosing paradigms to account fo

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::5c9b782ae9754b780858dc452d6dca43
https://doi.org/10.1016/j.rdc.2021.09.010