Results 301 to 310 of about 1,501,016 (387)

The usefulness of DST in predicting response to antidepressants: A placebo-controlled study

, 1986
Anastasios Georgotas, Peter E. Stokes, Robert E. McCue, Arthur Dubow, Joan Welkowitz, Eitan Friedman, C Fanelli, I. Chang, Thomas B. Cooper   +8 more
openalex   +1 more source

Pharmacokinetics, Safety, and Skin Irritation and Sensitization Potential of Clascoterone Cream in Early‐Phase Clinical Study Participants

Clinical Pharmacology in Drug Development, EarlyView.
Abstract Clascoterone is an androgen receptor inhibitor approved for the treatment of acne vulgaris in patients 12 years of age and older. Here, we report results of 5 phase 1 studies that assessed the pharmacokinetics (PK), safety, and skin irritation and sensitization potential of clascoterone cream 1% in healthy participants and patients with acne ...
Andrea Francesco Daniele Di Stefano, Milko Massimiliano Radicioni, Gerhard Garhöfer, Martina Cartwright, Markus Müller, Iris Kopeloff, Luigi Moro, Nicholas Squittieri, Alessandro Mazzetti   +8 more
wiley   +1 more source

A Comparison of SGLT2 or DPP-4 Inhibitor Monotherapy vs Placebo for Type 2 Diabetes in Adolescents vs Young Adults. [PDF]

J Endocr Soc
Laffel LM, Danne T, Klingensmith GJ, Schueler E, Tartakovsky I, Nessralla L, Zeitler P, Willi S.   +7 more
europepmc   +1 more source

Comparative single‐cell analysis of esophageal cancer subtypes reveals tumor microenvironment distinctions explaining varied immunotherapy responses

Cancer Communications, EarlyView.
Seungbyn Baek, Junha Cha, Min Hee Hong, Gamin Kim, Yoon Woo Koh, Dahee Kim, Wonrak Son, Chan‐Young Ock, Seungeun Lee, Martin Hemberg, Seong Yong Park, Hye Ryun Kim, Insuk Lee   +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

A dose of doubt: a qualitative study on placebo regulations. [PDF]

Front Med (Lausanne)
Richard M, Ganz M, Elger BS, Gaab J.
europepmc   +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

Impact of supplementing Limosilactobacillus fermentum MN-LF23 on the eradication of Helicobacter pylori with 14-day standard quadruple therapy: a randomized, double-blind, placebo-controlled trial. [PDF]

Nutr J
Zhao Y, Niu X, Zhang Y, Zhao L, Zhang L, He J, Zhang Q, Mao Y, Wang F, Zhao X, Wang R.   +10 more
europepmc   +1 more source

Use of colonic eicosanoid concentrations as predictors of relapse in ulcerative colitis: double blind placebo controlled study on sulphasalazine maintenance treatment.

, 1988
K. Lauritsen, L. Laursen, Klaus Bukhave, J Rask-Madsen   +3 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