Results 121 to 130 of about 8,315 (221)
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 sourceClinical Model‐Informed Precision Dosing Consult Service for Accelerating Personalized Medication in Pediatric Patients
Clinical Pharmacology &Therapeutics, EarlyView.Traditional dosing strategies often rely on a “one‐size‐fits‐all” paradigm, assuming an “average” patient with typical demographic and pharmacological characteristics. In reality, this often overlooks existing between‐patient variability and can lead to suboptimal drug exposure or toxicity. This issue is especially pronounced in pediatric patients, who Zachary L. Taylor, Takanobu Nadai, Kei Irie, Wen Rui Tan, Sanjana Parikh, Anhar Hosawi, Matthijs W. van Hoogdalem, Ronaldo Morales Junior, Sonya Tang Girdwood, Abbie D. Leino, Kana Mizuno, Alexander A. Vinks, Tomoyuki Mizuno +12 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 sourceLong‐Acting Therapeutics in Pediatric Health: Bridging Innovation and Access
Clinical Pharmacology &Therapeutics, EarlyView.Children have distinct therapeutic needs arising from age‐dependent physiology, disease epidemiology, formulation requirements, dosing considerations, and safety vulnerabilities. Despite substantial reductions in childhood mortality over the past three decades, nearly 5 million children under five died in 2023, with infectious diseases continuing to ...Prajith Venkatasubramanian, Moherndran Archary, Daniel B. Hawcutt, Rachel Daley, Edmund Capparelli, Adeniyi Olagunju +5 morewiley +1 more sourceHow to Optimize Healthy Volunteer Screening and Enrolment in Clinical Trials: A Qualitative and Quantitative Approach to Evaluate Processes and Healthy Volunteers' Perceptions
Clinical Pharmacology &Therapeutics, EarlyView.Healthy volunteers (HVs) are essential for phase I trials, yet their recruitment and screening remain resource‐intensive and ethically complex. High screening failure (SF) rates highlight the need to evaluate and understand all aspects of the enrolment processes. We analyzed SF patterns in a large German HV cohort and explored participants' motivations,Evelyn Krohmer, Manuela König, Cathrin J. Vogt, Marina Streckebein, Sybille Baumann, Max Blumenstock, Ruwen Böhm, Fabian Müller, Nadja Struß, Viktoria S. Wurmbach, Antje Blank +10 morewiley +1 more sourcePhase I Evaluation of Siltartoxatug, a First‐in‐Class Anti‐Tetanus Monoclonal Antibody: Safety, Pharmacokinetics and Pharmacodynamics in Healthy Australian and Chinese Populations
Clinical Pharmacology &Therapeutics, EarlyView.Siltartoxatug, a first‐in‐class monoclonal antibody targeting tetanus toxin for post‐exposure prophylaxis, was evaluated in two phase I trials in Australian and Chinese healthy adults. In these randomized, double‐blind, placebo‐controlled, dose‐escalation studies, participants received a single intramuscular injection of siltartoxatug (10–250 μg/kg) or Xinyu Liu, Zhigang Liu, Xiaohu Kuang, Yueming Wang, Xiaoyi Liu, Jiyuan Ding, Xia Zhou, Xin Zhou, Qianyu Liang, Meizhuo Zhang, Hao Zhao, Qingqing Tan, Weihong Zheng, Huaxin Liao, Charlotte Lemech, Wanmei Wang +15 morewiley +1 more source
