Results 181 to 190 of about 30,551 (254)
Advances in New Approach Methodologies at FDA's Division of Applied Regulatory Science
Clinical Pharmacology &Therapeutics, EarlyView.New Approach Methodologies (NAMs) represent a paradigm shift in drug development and regulatory science, offering human‐relevant alternatives to traditional preclinical models. This mini‐review highlights recent advances in NAM development, validation, and regulatory application from FDA's Division of Applied Regulatory Science (DARS).Ksenia Blinova, Kimberly Chiu, Anik Chaturbedi, Jahan Cooper, Tromondae K. Feaster, Paula L. Hyland, Lidiya Stavitskaya, Wendy W. Wu, Jeffry Florian, Rodney Rouse +9 morewiley +1 more sourceCYP2D6‐Guided Opioid Therapy for Chronic Pain: A Multi‐Center Pragmatic Randomized Controlled Trial
Clinical Pharmacology &Therapeutics, EarlyView.The analgesic effectiveness of several opioids depends on CYP2D6‐mediated metabolism to more active opioid receptor agonists. CYP2D6 activity is impacted by genetic variability and medications that inhibit CYP2D6. We conducted a pragmatic, multi‐center, randomized, controlled trial to determine whether CYP2D6‐guided opioid prescribing improves chronic ...Todd C. Skaar, Rachel A. Myers, Roger B. Fillingim, John T. Callaghan, Kerri L. Cavanaugh, Hrishikesh Chakraborty, Jordan F. Baye, Emily J. Cicali, Michael T. Eadon, Erica N. Elwood, Elizabeth C. Harris, Lindsay J. Hines, Khoa A. Nguyen, Michelle A. Ramos, Marc Rosenman, Azita Sadeghpour, Saskia Shuman, Rajbir Singh, Emma M. Tillman, Christina M. Wyatt, Carol R. Horowitz, Deepak Voora, Lori A. Orlando, Josh F. Peterson, Larisa H. Cavallari, Julie A. Johnson, Paul R. Dexter, on behalf of the IGNITE Pragmatic Trials Network, 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, 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, Ryanne Wu, 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, Paul Dexter, Abi Colwell, Amy M. Breman, Zeruesenay Desta, Cathy Fulton, Jennelle C. Hodge, Sheryl Lynch, Jonathan Oliver, Victoria M. Pratt, Ross Robinson, Elizabeth Rowe, Jennifer Stuart, Emma Tillman, Ashley 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, Kimberly Snell, Ana Tomescu, Megan Trietsch, James Walker, Deanna Web, Erin Whiting, Russell A. Wilke, Simona Volpi, Sarah Hutchison, Natalie Kucher, Ebony Madden, Jessica Reinach, Renee Rider, Ismail Safi, Ella Samer, Lori Orlando, Lani Banez, Lisa Bendz, Jackie Jordan, Ann McGee, Christina Nix, Lorraine Vergara, Tyler Colon, Aaishah Francis, Samantha Guagliardo, Najiba Khan, Camila Tan Lam, Michelle Sciarrino, Emma Maiman‐Stadtmauer, Sofia Medina‐Pardo, Ololade (Lola) Williams, Sheng Luo, Kevin Anstrom, Alicia Ellis, Stephen Ellis, Hwasoon Kim, Peter Merrill, Lilin She, Jennifer Shepherd, Saira Siddiqui, Jun Wen, Brittany Davis, John Howard, Alia Jamison, Lydia Joyner, Ellie Kiihne, Johnathan Oliver, Libbie Silverman, Jordan Sonneville Jennifer Stuart, Laurel Tokar, Neil Calman, Daviana Buck, Nicole Canchucaja Porshia Cook, Ariel Jacobs Danielle John, Mirta (Mimi) Milanes, Wambui Ngari, Megan Triestch, Abraham Garcia, Carol Gutierrez, Steven Houtschilt, Maria Lopez, Alan Mejia, Anaite Montes Bu, Deanna Webb, Sonja White, Ali Brewer, Brittni Deadrick, Alexis Meyer, Blair Svennes, Hana Al Alshaykh, Tala Basha, Asia Cobb, Brendon Cooper, Amanda Elchynski, Amanda Elsey, Anuksha Gotmare, Lauren Lemke, Arielle Nelson, Michael Read, 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, Jose Alonso, Jeffery Gainer, Morgan Howard, Fatoumata Kaba, Brianna Rivers, Liliana Serrano, Kimberly Vigal, ADeia Williams, Angelo Lazaro, Salisha Merryshow, Henry Ong, John Thomas Callaghan, Raheleh Rahimi Darabad, Daniel Getu, Katherine Huber, Judive Jocelyn, Robin Morman Li, Rosalena Muckle, Brandi Plunkett, Siegfried Schmidt, Evgenia Teal, Petra Townsend, Joshua R. Wellington +255 morewiley +1 more sourceRetraction: The effects of the M2a macrophage-induced axonal regeneration of neurons by arginase 1. [PDF]
Biosci RepZhang J, Li Y, Duan Z, Kang J, Chen K, Li G, Weng C, Zhang D, Zhang L, Wang J, Li B. +10 moreeuropepmc +1 more sourceMedication Use During Breastfeeding—An Understudied Population: A Five‐Year Experience in the Pharmacovigilance Center of Lyon
Clinical Pharmacology &Therapeutics, EarlyView.Medication use during breastfeeding is common, yet data on drug transfer into breast milk and infant exposure remain limited. This study describes real‐world requests concerning medication compatibility with breastfeeding managed by the Lyon pharmacovigilance center over five years.Blandine Bertin, Aurore Gouraud, Anthony Facile, Fanny Ledys, Sabrina Pierre, Véronique Pizzoglio, Thierry Vial, Marine Auffret, Marina Atzenhoffer +8 morewiley +1 more source