Results 151 to 160 of about 104,915 (286)

Perspectives of Academic Oncologists About Offering Expanded Access to Investigational Drugs.

JAMA Netw Open, 2022
Gould P, Salam T, Kimberly L, Bateman-House A, Fernandez Lynch H.   +4 more
europepmc   +1 more source

Continuous outcome estimation in N‐of‐1 trials for accelerated decision‐making

Epilepsia, EarlyView.
Abstract Objective N‐of‐1 trials aim to determine the therapeutic effect for a single individual. This individualized approach necessitates collecting multiple data points over time through repeated alternating periods of active treatment and a comparator or control condition.
Victoria Defelippe, František Bartoš, Eric‐Jan Wagenmakers, Kees P. J. Braun, Floor E. Jansen, Willem M. Otte   +5 more
wiley   +1 more source

Possibilities of adaptive design implementation in clinical trials of next-in-class drugs

Регуляторные исследования и экспертиза лекарственных средств, 2018
The article investigates the possibility of streamlining the methodology of clinical studies of next-in-class drugs by implementing an adaptive design. Next-in-class drugs are original drugs with known biological targets, similar in structure and mode of
N. V. Vostokova, Yu. A. Trakhtenberg, E. A. Smolyarchuk, A. A. Svistunov   +3 more
doaj  

Evolution of the European Medicines Agency clinical guidelines for epilepsy drug development between 2010 and 2025: A comparative analysis by the ILAE Task Force on Regulatory Affairs

Epilepsia, EarlyView.
Abstract Objective The latest European Medicines Agency (EMA) guideline on the clinical investigation of medicines to treat epileptic disorders was adopted by the EMA Committee for Medicinal Products for Human Use in 2025. We compared this guideline with the previous version (2010), highlighting areas where significant revisions were introduced ...
Stéphane Auvin, Alexis Arzimanoglou, Jacqueline French, Kelly G. Knupp, Lieven Lagae, Eugen Trinka, Dennis Dlugos, Emilio Perucca   +7 more
wiley   +1 more source

Targeting SARS-CoV-2 Nsp12/Nsp8 interaction interface with approved and investigational drugs: an in silico structure-based approach. [PDF]

J Biomol Struct Dyn, 2022
Mutlu O, Ugurel OM, Sariyer E, Ata O, Inci TG, Ugurel E, Kocer S, Turgut-Balik D.   +7 more
europepmc   +1 more source

Stiripentol: Unpublished results from the first phase 2 clinical trial in Lennox–Gastaut syndrome conducted in the early 1990s

Epilepsia, EarlyView.
Abstract Objective This study was undertaken to present the results of an exploratory phase 2 trial of stiripentol in Lennox–Gastaut syndrome (LGS). Methods This exploratory single‐blind, single‐arm, nonrandomized sequential‐period phase 2 study was conducted at four centers in France between January 1989 and August 1993.
Stéphane Auvin, Benjamin Serraz, Jérémie Lespinasse, Laurent Chancharme   +3 more
wiley   +1 more source

Promising Drugs Targeting Specific Mechanisms of Deregulation in T Cell Lineage Acute Lymphoblastic Leukemia

Oncology and Therapy
T cell acute lymphoblastic leukemia (T-ALL) is a class of hematological malignancies predominantly affecting children, adolescents, and young adults, marked by aggressive behavior and poor clinical response, especially in relapsing cases.
Xavier Thomas
doaj   +1 more source

Occurrence of Potential Adverse Drug Events from Prescribing Errors in a Pediatric Intensive and High Dependency Unit in Hong Kong: An Observational Study [PDF]

, 2017
Cheung, Hon Ming, Ewig, Celeste L., Kam, Kwok Ho, Knoderer, Chad A., Wong, Hiu Lam   +4 more
core   +2 more sources

Defining the end point of status epilepticus: A scoping review and framework for standardization

Epilepsia, EarlyView.
Abstract Status epilepticus (SE) is a life‐threatening neurological emergency with consensus‐driven definitions for onset but no standardized criteria for its end point. This gap creates uncertainty in research and clinical practice. We conducted a scoping review to evaluate how end points have been defined in SE research and to identify key areas of ...
Fawad A. Khan, Margaret T. Gopaul, Samuel L. Carter, Anil Chimakurthy, Summer Skelton, Lawrence J. Hirsch, Eugen Trinka   +6 more
wiley   +1 more source

Ranking of antiseizure medications in a panel of focal seizure models predicts their comparative efficacy in clinical add‐on trials in drug‐resistant focal epilepsy

Epilepsia, EarlyView.
Abstract Objective Most antiseizure medications (ASMs) have been discovered by testing in animal models, which are generally thought to predict antiseizure activity in patients. However, it is not known whether any of these models (or a combination of models) can predict whether a novel ASM exhibits higher clinical efficacy in focal drug‐resistant ...
Wolfgang Löscher, Pavel Klein
wiley   +1 more source