Results 191 to 200 of about 615,598 (259)

From Prediction to Decision Making: PBPK and QSP as Regulatory‐Grade NAMs

Clinical Pharmacology &Therapeutics, EarlyView.
New approach methodologies (NAMs) encompass a diverse and rapidly evolving set of experimental and computational tools designed to generate human‐relevant mechanistic data for use in drug development and regulatory decision making. Experimental NAMs provide insights into drug disposition, pharmacological activity, and disease biology that are difficult
Karen Rowland Yeo, Piet H. van der Graaf
wiley   +1 more source

Model‐Informed Dose Optimization of Anakinra in Preterm Neonates Implications for Safe and Effective Dosing

Clinical Pharmacology &Therapeutics, EarlyView.
Anakinra, an interleukin‐1 receptor antagonist, shows promise for reducing inflammatory complications of premature birth. However, the pharmacokinetics (PK) of anakinra in neonates has not been characterized, limiting evidence‐based dosing. This study aimed to develop a population PK model for anakinra to guide dosing in preterm neonates.
Jia Li, David K. Metz, Elys Green, Gergely Toldi, Robert Galinsky, Megan Clark, Rebecka Atkinson, Ina Rudloff, Josephine C. Owen, Sara K. DiSimone, Samuel C. Forster, Steven X. Cho, Atif Majid, Graeme R. Polglase, Marcel Favilla, Pramod Pharande, Atul Malhotra, Calum T. Roberts, Scott H. Stansfield, Arvind Sehgal, Kenneth Tan, Alistair J. Gunn, Philip J. Berger, Alex Veldman, Rod W. Hunt, Claudia A. Nold‐Petry, Marcel F. Nold, Carl M. J. Kirkpatrick   +27 more
wiley   +1 more source

Effect of Automatic Infant Swing on Sleep-Wake Cycles and Comfort: A Randomized Controlled Study Protocol. [PDF]

Nurs Crit Care
Bolacali ET, Ertürk F, Özcan B, Kücükoğlu S.   +3 more
europepmc   +1 more source

Finding My Path: Listening, Learning, and Leading in Rare Disease: The 2025 Hower Award

Annals of the Child Neurology Society, EarlyView.
Andrea Gropman
wiley   +1 more source

Pediatric Developmental Safety Assessment and New Approach Methodologies: US FDA/Triangle CERSI Workshop Report

Clinical Pharmacology &Therapeutics, EarlyView.
Pediatric developmental safety assessment presents distinct challenges in drug development. Children undergo dynamic changes in organ systems and drug disposition pathways during development, and drug‐related effects may be delayed or manifested differently than in adults.
Gilbert J. Burckart, Gelareh Abulwerdi, Christin L. Daniels, Calib Choi, Rebecca Racz, Jean‐Pierre Valentin, Kristin Ardlie, Nicholas Tatonetti, Susan Laffan, Marjory Moreau, Will Redfern, Lang Li, James J. Hickman, Rajanikanth Madabushi, Bhagwat Prasad, Lynne Yao, Paul B. Watkins   +16 more
wiley   +1 more source

Integrating immediate Kangaroo Mother Care as an integral part of small and sick newborn care in facilities with level 2 Special Newborn Care Units: Implementation Research Protocol. [PDF]

Gates Open Res
iKMC-IR Study Group, Yoshida S, Portela A, iKMC-IR Study Group .   +3 more
europepmc   +1 more source

Systemic aging fuels heart failure: Molecular mechanisms and therapeutic avenues

ESC Heart Failure, Volume 12, Issue 2, Page 1059-1080, April 2025.
Abstract Systemic aging influences various physiological processes and contributes to structural and functional decline in cardiac tissue. These alterations include an increased incidence of left ventricular hypertrophy, a decline in left ventricular diastolic function, left atrial dilation, atrial fibrillation, myocardial fibrosis and cardiac ...
Zhuyubing Fang, Umar Raza, Jia Song, Junyan Lu, Shun Yao, Xiaohong Liu, Wei Zhang, Shujuan Li   +7 more
wiley   +1 more source

Acceptance of the respiratory syncytial virus infant monoclonal antibody nirsevimab among post-partum women in Italy. [PDF]

Hum Vaccin Immunother
Angelillo S, Miraglia Del Giudice G, Della Polla G, Angelillo IF, Collaborative Working Group.   +4 more
europepmc   +1 more source

Facilitating the timely diagnosis of Lennox–Gastaut syndrome: A checklist to support clinical practice

Epileptic Disorders, EarlyView.
Abstract Objective To develop and evaluate a simple‐to‐use checklist to support physicians with the timely diagnosis of Lennox–Gastaut syndrome (LGS). Methods A panel of 10 pediatric and adult epileptologists used the International League Against Epilepsy (ILAE) criteria for LGS classification and definition to develop seven questions for the checklist,
Nicola Specchio, Alexis Arzimanoglou, Stéphane Auvin, Antonio Gil‐Nagel, Lieven Lagae, Rima Nabbout, Susanne Schubert‐Bast, Adam Strzelczyk, Eugen Trinka, J. Helen Cross   +9 more
wiley   +1 more source

Synchronous brain activity in newborn infants and their mothers during parent-led multimodal pain alleviation with skin-to-skin contact, breastfeeding and lullaby singing: Study protocol for a fNIRS hyperscanning study. [PDF]

PLoS One
Eriksson M, Lund M, Msghina M, Reingardt M, Ullsten A.   +4 more
europepmc   +1 more source