Results 271 to 280 of about 8,509,826 (346)

Clinical Evaluation of Potential Interaction Between Bemnifosbuvir and Ruzasvir With an Assessment of Food Effect: Results of a Phase 1 Study in Healthy Participants

Clinical Pharmacology in Drug Development, EarlyView.
Abstract A combination of nucleotide hepatitis C virus (HCV) nonstructural protein (NS) 5B and 5A inhibitors is a preferred standard of care for treating chronic HCV. Bemnifosbuvir is a novel oral guanosine nucleotide prodrug with potent pan‐genotypic inhibitory activity against HCV NS5B.
Xiao‐Jian Zhou, Gaetano Morelli, Maureen Montrond, Shannan Lynch, Keith Pietropaolo, Bruce Belanger, Arantxa Horga, Janet Hammond   +7 more
wiley   +1 more source

Acute Effects and Pharmacokinetics of LSD after Paroxetine or Placebo Pre‐Administration in a Randomized, Double‐Blind, Cross‐Over Phase I Trial

Clinical Pharmacology &Therapeutics, EarlyView.
Psychedelics, such as psilocybin and lysergic acid diethylamide (LSD), are being investigated for the treatment of depressive and anxiety disorders, for which concomitant treatment with selective serotonin reuptake inhibitors (SSRIs) is prevalent.
Anna M. Becker, Mélusine Humbert‐Droz, Lorenz Mueller, Alen Jelušić, Avram Tolev, Isabelle Straumann, Isidora Avedisian, Livio Erne, Jan Thomann, Dino Luethi, Edna Grünblatt, Henriette Meyer zu Schwabedissen, Matthias E. Liechti   +12 more
wiley   +1 more source

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

The Effectiveness of Intramuscular Dexmedetomidine on Hemodynamic Responses During Tracheal Intubation and Anesthesia Induction of Hypertensive Patients: A Randomized, Double-Blind, Placebo-Controlled Study

, 2007
Kudret Doğru, Tugba Arik, Karamehmet Yıldız, Cihangir Biçer, Halit Madenoğlu, Adem Boyacı   +5 more
openalex   +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

Placebo‐Controlled, Dose‐Response Trial to Assess the Efficacy and Risk of Zinc Supplementation, With or Without Copper, on Plasma Zinc Concentrations, Morbidity, Markers of Copper Status and Growth of Young Ecuadorian Children at Risk of Zinc Deficiency

, 2007
Sara Wuehler, Fernando Sempértegui, Kenneth H. Brown   +2 more
openalex   +1 more source

Confirmation of Fixed Quarterly Riliprubart Regimen in Patients with Cold Agglutinin Disease Using Population PK/PD and Exposure‐Response Analyses

Clinical Pharmacology &Therapeutics, EarlyView.
Riliprubart is a second‐generation, humanized immunoglobulin G4 that inhibits only the activated form of the C1s component of the proximal classical complement pathway. The clinical studies of riliprubart conducted thus far for the treatment of cold agglutinin disease (CAD), a rare autoimmune disease, include a Phase 1 first‐in‐human study in healthy ...
Timothy Chow, Marek Wardecki, Michael Storek, Nancy Wong   +3 more
wiley   +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