Results 211 to 220 of about 455,818 (276)

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 more
wiley   +1 more source

Seizure Burden before and after Lidocaine as Add-On Therapy in (Amplitude-Integrated) Electroencephalography-Confirmed Neonatal Seizures.

Neonatology
Rondagh M, van Oldenmark BO, van Steenis A, Tromp SC, Tan RNGB, Lopriore E, Steggerda SJ, de Vries LS.   +7 more
europepmc   +1 more source

Neonatal Seizures as a First Sign of Inferior Vena Cava Thrombosis: Diagnostic and Therapeutic Challenges. [PDF]

Turk Arch Pediatr
Pereira MO, Pereira RL, Machado C, Silva A.   +3 more
europepmc   +1 more source

Clinical 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 more
wiley   +1 more source

Comparing the Effectiveness and Safety of Intravenous Levetiracetam and Phenobarbital as First-Line Therapies for Neonatal Seizures: A Randomized Clinical Trial. [PDF]

Iran J Child Neurol
Khosroshahi N, Kamrani K, Moradi M, Sadeghirad P, Khabazi Oskouie A.   +4 more
europepmc   +1 more source

Maternal Dipyrone Exposure and Risk of Major Congenital Malformations, Adverse Perinatal and Postnatal Outcomes: A Population‐Based Cohort Study

Clinical Pharmacology &Therapeutics, EarlyView.
Pain and fever are common in pregnancy. Dipyrone is widely used in Europe, Latin America, and parts of Asia, but is banned in other countries due to concerns about agranulocytosis. Evidence on its safety in pregnancy remains limited and inconsistent. This study aimed to evaluate whether maternal dipyrone use during the first‐ and third‐trimesters is ...
Itamar Ben Shitrit, Daphna Idan, Ariel Avraham Hasidim, Tal Michael, Amalia Levy, Gali Pariente, Eitan Lunenfeld, Sharon Daniel   +7 more
wiley   +1 more source

Efficacy of Levetiracetam vs Phenobarbital as First Line Therapy for the Treatment of Neonatal Seizures. [PDF]

J Pediatr Pharmacol Ther
Long D, Sutton C, Hale J.
europepmc   +1 more source

Long‐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 more
wiley   +1 more source

Special Populations in Pivotal Clinical Trials: Eligibility and Supporting Evidence for Exclusion in EMA‐Authorised Medicines

Clinical Pharmacology &Therapeutics, EarlyView.
Evidence on the efficacy and safety of medicines supporting marketing authorization is largely derived from randomized controlled trials, yet these trials often exclude populations likely to use the medications in clinical practice. This study assessed eligibility of special populations, defined as pregnant and breast‐feeding individuals, elderly ...
Maja J. Jørgensen, Débora D. Gräf, Christine E. Hallgreen   +2 more
wiley   +1 more source

Parent and Family Well-Being and Associated Risk Factors as Children with Neonatal Seizures Reach Preschool and School-Age: A Longitudinal Cohort Study. [PDF]

J Pediatr Clin Pract
Franck LS, Lemmon ME, Grossbauer L, Pawlowski K, Sturza JS, Wusthoff CJ, Massey SL, Chu CJ, Soul JS, Numis AL, Thomas C, Benedetti GM, Anwar T, Berl MM, Gidley Larson JC, Rogers EE, Chen C, McCulloch CE, Glass HC, Shellhaas RA.   +19 more
europepmc   +1 more source