Results 261 to 270 of about 116,751 (358)

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

What should constitute a control condition in psychedelic drug trials? [PDF]

Nat Ment Health
Colloca L, Fava M.
europepmc   +1 more source

Immunotherapy of genital warts with inosine pranobex and conventional treatment: double blind placebo controlled study. [PDF]

, 1988
J Davidson-Parker, W W Dinsmore, Md Mahmudul Hasan Khan, David A. Hicks, C. Morris, D F Morris   +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

Vitamin D Supplementation and Allergic Rhinitis: A Systematic Review and Meta-Analysis. [PDF]

Medicina (Kaunas)
Kawada K, Sato C, Ishida T, Nagao Y, Yamamoto T, Jobu K, Hamada Y, Izawa Ishizawa Y, Ishizawa K, Abe S.   +9 more
europepmc   +1 more source

A comparative double blind study of amoxycillin/clavulanate vs placebo in the prevention of infection after animal bites.

, 1989
P. H. Brakenbury, C L Muwanga
openalex   +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

Revisiting the SSRI vs. placebo debate in the treatment of social anxiety disorder: the role of expectancy effects, neural responsivity, and monoamine transporters. [PDF]

Front Psychol
Furmark T, Wahlstedt K, Faria V.
europepmc   +1 more source

Myocardial contractility and performance capacity after magnesium infusions in young healthy persons: A double‐blind, placebo‐controlled, cross‐over study

, 1988
Henrik Rasmussen, R. Videbæk, Thomas Melchior, Peter Aurup, C. Cintin, Niels T. Pedersen   +5 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