Results 181 to 190 of about 505,109 (233)
A White Paper on Advancing Long‐Acting Therapeutics for Maternal and Pediatric Health by Bridging Gaps in Clinical Research, Access and Regulation
Clinical Pharmacology &Therapeutics, EarlyView.As use cases for long‐acting therapeutics expand across clinical indications, there is a critical need to ensure the inclusion of women who are pregnant or breastfeeding, infants and children—populations with a historical gap in the availability of interventions already approved for use in adults.Moherndran Archary, Robert Bies, Osei Boateng, Rachel Daley, Pierre Gashema, Mili Karina, Emily Njuguna, Sharon Nachman, Nathaniel Nkrumah, Carolyne Odula, Andrew Owen, Ethel D. Weld, Prajith Venkatasubramanian, Adeniyi Olagunju, on behalf of the Community of Practice for Long‐acting Therapeutics for Maternal and Paediatric Health, Rana Abutaima, Dorothy Akongo, Abdulnaser Alsharaa, Moherndran Archary, Shakir Atoyebi, Benoit Bestgen, Robert Bies, Osei Boateng, Andrew Butler, Edmund Capparelli, Rachel Daley, Layla Davies, Joelle Dountio, Henry Enzama, Pierre Gashema, Katila George, Dan Hawcutt, Rene Holm, Patrick Gad Iradukunda, Elodie Jambert, Mili Karina, Linda Lewis, Grace Miheso, Sebastien Morin, Andrew Morrison, Sharon Nachman, Shadia Nakalema, Emily Njunga, Nathaniel Nkrumah, Carolyne Odula‐Obonyo, Brenda Okware, Adeniyi Olagunju, Andrew Owen, Martina Penazzato, Natella Rakhmanina, Mphako Brighton Ratlabyana, Rachel Scott, Kimberly Struble, Andre‐Marie Tchouatieu, Catherine Unsworth, Prajith Venkatasubramanian, Catriona Waitt, Ethel Weld, Janine Winterbottom, Leena Zino +59 morewiley +1 more sourceTramadol Co‐Administration with Oxycodone or Hydrocodone Increases Opioid Burden without Improving Postoperative Pain Control
Clinical Pharmacology &Therapeutics, EarlyView.Tramadol is frequently co‐prescribed with oxycodone or hydrocodone after surgery under the assumption that its dual mechanism of action provides an opioid‐sparing benefit. However, evidence supporting this practice is limited and inconsistent. We conducted a secondary analysis of the multicenter IGNITE ADOPT‐PGx pragmatic trial of patients undergoing ...Noor A. Nahid, Ahmed I. Soliman, Jordan F. Baye, Natasha J. Petry, Chancellor F. Gray, Rachel A. Myers, Erica N. Elwood, Elizabeth C. Harris, Hrishikesh Chakraborty, Simona Volpi, Renee Rider, Paul R. Dexter, Josh F. Peterson, Todd C. Skaar, Hari K. Parvataneni, Larisa H. Cavallari, Julie A. Johnson, on behalf of the IGNITE Pragmatic Trial Network Investigators, L Orlando, D Voora, C Horowitz, C Horowitz, N Calman, T Skaar, T Skaar, P Dexter, T Skaar, P Dexter, J Johnson, L Cavallari, J Johnson, L Cavallari, J Johnson, L Cavallari, K Blake, K Blake, K Blake, J Peterson, J Peterson, K Cavanaugh, R Singh, R Singh, L Hines, C Wyatt, H Chakraborty, Rishi Chakraborty, Christina Wyatt, Geoff Ginsburg, Kady‐Ann Steen‐Burrell, Bhargav Adagarla, Sarah George, Beth Harris, Jaclyn Holland, Yashika Johnson, Phyllis Kennel, Kristen Linney, Rania Metry, Rachel Myers, Wanda Parker, Gayle Passmore, Carol Pereira, Teji Rakhra‐Burris, Deepak Voora, Ryanne Wu, Teji Rakhra‐Burris, Azita Sadeghpour, Ruth Lehan, Tyffany Locklear, Carol Horowitz, Michelle Ramos, Sabrina Clermont, Bart Ferket, Kenneth Fifer, Diane Hauser, Joseph Kannry, James Murrough, Aniwaa Owusu Obeng, Janet Seo, Tatiana Sabin, Nandini Shroff, Saskia Shuman, Todd Skaar, Paul Dexter, Abi Colwell, Amy Breman, Zeru Desta, Cathy Fulton, Jennelle Hodge, Sheryl Lynch, Jonathan Oliver, Vicky Pratt, Ross Robinson, Elizabeth Rowe, Jennifer Stuart, Emma Tillman, Ashely Vetor, Julie Johnson, Larisa Cavallari, Alexander Parker, Erica Elwood, Kathryn Blake, Emily Cicali, Kelsey Cook, Karam Diaby, Julio Duarte, Ben Duong, Karla Giron, Elizabeth Eddy, Julia Krutov, Carol Mathews, Haesuk Park, Robyn Nelson, Ryan Rhoden, Caroline Schlierle, Taylor Sullivan, Almut Winterstein, Kristen Wiisanen, Josh Peterson, Kerri Cavanaugh, Sara Van Driest, Sara Block, Jordan Baye, Michelle Benck, Chantel Bender, Sylvia Eluhu, Colette Free, Shane Gonnelly, Sarah Hedeen, Lindsay Hines, Steve Houtschilt, Michelle Liu, Salisha Marryshow, Nicole Neville, Natasha Petry, Sidd Pratap, Vernon Sherden, Rajbir Singh, Kimberly Snell. Ana Tomescu, Megan Trietsch, James Walker, Deanna Web, Erin Whiting, Russ Wilke, Simona Volpi, Sarah Hutchison, Natalie Kucher, Ebony Madden, Jessica Reinach, Renee Rider, Ismail Safi, Ella Samer, Lori Orlando, Deepak Voora, Azita Sadeghpour, Lani Banez, Lisa Bendz, Jackie Jordan, Ruth Lehan, Tyffany Locklear, Ann McGee, Christina Nix, Lorraine Vergara, Ryanne Wu, Carol Horowitz, Michelle Ramos, Sabrina Clermont, Tyler Colon, Aaishah Francis, Samantha Guagliardo, Najiba Khan, Camila Tan Lam, Michelle Sciarrino, Emma Maiman‐Stadtmauer, Sofia Medina‐Pardo, Tatiana Sabin, Janet Seo, Lola) Williams, Rishi Chakraborty, Christina Wyatt, Geoff Ginsburg, Sheng Luo, Kady‐Ann Steen‐Burrell, Kevin Anstrom, Bhargav Adagarla, Alicia Ellis, Stephen Ellis, Sarah George, Beth Harris, Jaclyn Holland, Yashika Johnson, Phyllis Kennel, Hwasoon Kim, Kristen Linney, Peter Merrill, Rania Metry, Rachel Myers, Wanda Parker, Gayle Passmore, Carol Pereira, Teji Rakhra‐Burris, Lilin She, Jennifer Shepherd, Saira Siddiqui, Jun Wen, Todd Skaar, Abi Colwell, Brittany Davis, John Howard, Alia Jamison, Lydia Joyner, Ellie Kiihne, Sheryl Lynch, Johnathan Oliver, Ross Robinson, Libbie Silverman, Jordan Sonneville Jennifer Stuart, Laurel Tokar, Ashley Vetor, Neil Calman, Saskia Shuman, Daviana Buck, Nicole Canchucaja Porshia Cook, Ariel Jacobs Danielle John, Samantha Guagliardo, Diane Hauser, Mimi) Milanes, Wambui Ngari, Nandini Shroff, Rajbir Singh, Megan Triestch, Abraham Garcia, Carol Gutierrez, Steven Houtschilt, Maria Lopez, Alan Mejia, Anaite Montes Bu, Deanna Webb, Sonja White, Kathryn Blake, Ben Duong, Taylor Sullivan, Ali Brewer, Kelsey Cook, Brittni Deadrick, Julia Krutov, Lindsay Hines, Jordan Baye, Colette Free, Michelle Benck, Shane Gonnelly, Sarah Hedeen, Alexis Meyer, Blair Svennes, Larisa Cavallari, Erica Elwood, Hana Al Alshaykh, Tala Basha, Emily Cicali, Asia Cobb, Brendon Cooper, Elizabeth Eddy, Amanda Elchynski, Amanda Elsey, Anuksha Gotmare, Karla Giron, Lauren Lemke, Arielle Nelson, Robyn Nelson, Michael Read, Ryan Rhoden, Genevieve Rosier, Isabella Schultz, Chiara Chermont Spina, Joshua Terrell, Alexa Valko, Precious Williams, Tracy Leonard, David Smith, Marian Davis, Vincent Guerra, Jennifer Salo, Claudia Cartaya Torres, Jorge Valedon, Paola Nieves Viana, Alexander Parker, Jose Alonso, Jeffery Gainer, Morgan Howard, Fatoumata Kaba, Brianna Rivers, Liliana Serrano, Kimberly Vigal, ADeia Williams, Josh Peterson, Kerri Cavanaugh, Sara Van Driest, Sara Block, Chantel Bender, Angelo Lazaro, Salisha Merryshow, Nicole Neville, Henry Ong, Erin Whiting +302 morewiley +1 more sourceFive Data-Informed Principles for Advancing Inclusive Research in Clinical Trials: A Pharma Perspective. 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Adv TherJames SL, Hede S, Ewing-Crawford AT, Bhagat R, Richie N, D'Rozario M, Theodore P, Lavery B, Bentouati S, Oron AP, Gillespie CW, Ryals CA, Bair-Merritt MH, Chesley J, Jiagge E, Jolain B. +15 moreeuropepmc +1 more sourceNon‐Invasive Estimation of Systemic Drug Exposure Using Exhaled Breath Metabolomics in Humans: A Translational Proof‐of‐Concept Study
Clinical Pharmacology &Therapeutics, EarlyView.Accurate assessment of systemic drug exposure in humans remains challenging, as conventional approaches rely on intermittent blood sampling and laboratory‐based assays that are invasive and provide limited temporal resolution. Exhaled breath contains volatile and semi‐volatile compounds arising from drug metabolism and downstream biological processes ...Kai Fricke, Diego M. Baur, Kapil Dev Singh, Felix Schmidt, Kathrin Müsch, Noriane A. Sievi, Marco Di Donato, Anton Schmick, Jonas Herth, Silvia Ulrich, Pablo Sinues, Marian Galovic, Malcolm Kohler +12 morewiley +1 more sourceToward the Use of Real‐World Data for Regulatory and HTA Decision‐Making: Experiences and Recommendations from Six EU‐Funded Projects
Clinical Pharmacology &Therapeutics, EarlyView.Real‐world data are increasingly important for regulatory and health technology assessment decision‐making, yet their effective use across Europe remains limited by technical, methodological, regulatory, and societal challenges. Drawing on the experiences of six Horizon Europe projects in the MetReal cluster, this review summarizes common barriers and ...Martin Russek, Jonas Peltner, Kerstin Pfeifer, Theodoros N. Arvanitis, Dirk De Valck, Sieta T. de Vries, Michel Dumontier, Vera Ehrenstein, Omaima El Hakouni, Gregory Epiphaniou, Gokhan Ertaylan, Joana Fernandes, Scott Hansen, Stuart Harrison, Erzsébet Horváth‐Puhó, Saif Ul Islam, Pekka Kahri, Julia K. Mader, Carsten Maple, Nikolaos Matragkas, Shivani Misra, Peter G.M. Mol, Anne Paakinaho, Sami Pakarinen, Martina Radanović, Evy Reviers, Kathrine Kold Sørensen, Marco Spruit, Christina Tikka, Anna‐Maija Tolppanen, Christian Torp‐Pedersen, Mirna Vela, Thuan Vo, Puriya Daniel Würtz Yazdanfard, Britta Haenisch +34 morewiley +1 more source