Results 311 to 320 of about 114,609 (356)

Impact of Model‐Informed Drug Development on Drug Development Cycle Times and Clinical Trial Cost

Clinical Pharmacology &Therapeutics, EarlyView.
Model‐informed drug development (MIDD) integrates data to quantify benefit/risk informing objective drug discovery and development decisions. An additional critical benefit of MIDD is postulated to be improvement in trial and program efficiencies. While the application of MIDD has grown, there have been no clear examples across programs to demonstrate ...
Vaishali Sahasrabudhe, Timothy Nicholas, Gianluca Nucci, Cynthia J Musante, Brian Corrigan   +4 more
wiley   +1 more source

First‐in‐Human Single and Multiple Ascending Dose Studies of Balinatunfib, a Small Molecule Inhibitor of TNFR1 Signaling in Healthy Participants

Clinical Pharmacology &Therapeutics, EarlyView.
Oral small molecule inhibitors of tumor necrosis factor alpha (TNFα) are emerging as attractive therapeutic agents for the treatment of various autoimmune diseases. Balinatunfib (SAR441566), a novel oral inhibitor of tumor necrosis factor receptor 1 (TNFR1) signaling, changes the configuration of the soluble TNFα (sTNFα) trimer and prevents its ...
Nassr Nassr, Faiza Rharbaoui, Dietmar Weitz, Johann Gassenhuber, Markus Rehberg, Markus Kohlmann, Fabienne Schumacher, Amel Lahmar, Andreas Kovar, Laurent Perrin, Frank‐Dietrich Wagner, Maria Wiekowski, Mai Anh Nguyen   +12 more
wiley   +1 more source

Supplementing Single‐Arm Trials with External Control Arms—Evaluation of German Real‐World Data

Clinical Pharmacology &Therapeutics, EarlyView.
As single‐arm trials (SATs) are increasingly used in pharmaceutical research, the validity of such study designs needs to be critically assessed. We characterize the feasibility of supplementing SATs with real‐world data (RWD)‐derived external control arms by determining the proportion of SATs on breast cancer and amyotrophic lateral sclerosis (ALS ...
Martin Russek, Jonas Peltner, Britta Haenisch   +2 more
wiley   +1 more source

Thorough QT/QTc study to evaluate the effect of a single supratherapeutic dose of islatravir on QTc interval prolongation in healthy adults. [PDF]

Antimicrob Agents Chemother
Matthews RP, Liu Y, Matthews C, Butterfield KL, O'Reilly T, Stoch SA, Iwamoto M.   +6 more
europepmc   +1 more source

Examining the Financial Impact of Biodiversity‐Related Reputational Disasters

Corporate Social Responsibility and Environmental Management, EarlyView.
ABSTRACT This research investigates the reaction of financial markets to biodiversity‐related corporate events, utilising an EGARCH model to assess the implications on stock returns and volatility. Results reveal that markets significantly respond to these events, demonstrating heightened sensitivity and volatility that underscore the financial ...
Erdinc Akyildirim, Shaen Corbet
wiley   +1 more source

Effects of Speed-Based Interventions to Reduce Bradykinesia in Individuals with Parkinson's Disease: A Systematic Review Protocol. [PDF]

Brain Sci
Benfica P, Scianni A, Magalhães J, Brito S, Martins J, Faria C.   +5 more
europepmc   +1 more source

Hierarchical clustering of clinical and flow cytometry parameters is associated with deterioration in patients with community‐acquired pneumonia in the emergency department: A preliminary study

Cytometry Part B: Clinical Cytometry, EarlyView.
ABSTRACT Anticipating the evolution of septic patients with community‐acquired pneumonia (CAP) is challenging for front‐line physicians in the Emergency Department (ED). Prognosis depends mainly on early identification, antibiotics, organ support, but also immune status.
Thomas Lafon, Robin Jeannet, Thomas Daix, Guillaume Monneret, Jean Feuillard   +4 more
wiley   +1 more source

Placebo effects beyond dopamine. [PDF]

PLoS Biol
Jensen KB.
europepmc   +1 more source

Does vitamin D supplementation impact serotonin levels? A systematic review and meta-analysis. [PDF]

Health Sci Rep
Alimohammadi-Kamalabadi M, Ziaei S, Hasani M, Mohammadi S, Mehrbod M, Morvaridi M, Persad E, Belančić A, Malekahmadi M, Estêvão MDDMAO, Daneshzad E, Heshmati J.   +11 more
europepmc   +1 more source