Results 231 to 240 of about 643,840 (294)

Serious Infection in Crohn's Disease Patients Treated With Ustekinumab: US Food and Drug Administration Active Postmarket Risk Identification and Analysis in the Sentinel Initiative

Clinical Pharmacology &Therapeutics, EarlyView.
The U.S. Food and Drug Administration (FDA) used an Active Postmarket Risk Identification and Analysis (ARIA) system to address a safety issue (serious infection) identified during clinical review of an application to market ustekinumab as a treatment for Crohn's disease (CD). FDA used an active‐comparator new‐user cohort design, data from six Sentinel
Joel L. Weissfeld, Geetha S. Iyer, Suna C. Seo, Andrew Giffin, Andrew L. Simon, Sheryl A. Kluberg, Emma R. Hoffman, Jamal T. Jones, Sarah K. Dutcher, Joyce A. Korvick   +9 more
wiley   +1 more source

More Than a Question of Correlation: Characterization of the Evidentiary Basis for Biomarker Surrogates Used in European Marketing Authorizations

Clinical Pharmacology &Therapeutics, EarlyView.
Traditionally, clinical outcomes measuring how a patient feels, functions, or survives are preferred endpoints in clinical trials; however, some may take a long time to manifest in slowly developing diseases. Biomarkers, if properly validated, can serve as surrogate endpoints, acting as substitutes for clinical outcomes.
Renske Johanna Grupstra, Viktoriia Starokozhko, Elisabeth Bakker, Anna Maria Gerdina Pasmooij, Peter Gerardus Maria Mol   +4 more
wiley   +1 more source

Mirror, mirror on the wall: The role for neuroscience in comparative psychotherapy research [PDF]

, 2013
Swanepoel, Annie
core  

Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition and Cancer Risk: Insights from a Large Propensity‐Matched Cohort Study

Clinical Pharmacology &Therapeutics, EarlyView.
Proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) lower LDL cholesterol and may influence cancer through immunomodulatory pathways. However, their effect on human cancer incidence remains unknown. We conducted a retrospective, propensity score‐matched study (Clalit Health Services, Israel, 2010–2023) comparing PCSK9 ...
Inbar Nardi Agmon, Chen Gurevitz, Tzippy Shochat, Shiri Kushnir, Guy Witberg, Amos Levi, Dan Gilon, Ran Kornowski, Paaladinesh Thavendiranathan, Husam Abdel Qadir, Zaza Iakobishvili   +10 more
wiley   +1 more source

Sexual networks and HIV in four African populations: the use of a standardised behvioural survey with biological markers [PDF]

, 2004
Carael, M, Glynn, JR, Lagarde, E, Morison, LA   +3 more
core  

Population Pharmacokinetics of Dupilumab in Adults, Adolescents, and Children With Eosinophilic Esophagitis

Clinical Pharmacology &Therapeutics, EarlyView.
Dupilumab, a fully human monoclonal antibody that blocks key drivers of type 2 inflammation, is approved across 8 diseases, including eosinophilic esophagitis. Subcutaneous dupilumab 300 mg weekly improved outcomes vs. placebo in adults (aged ≥ 18 years) and adolescents (aged ≥ 12 to < 18 years) during the phase III LIBERTY EoE TREET study (NCT03633617)
Jenny‐Hoa Nguyen, Mirna Chehade, Evan S. Dellon, Allen Radin, Jason Chittenden, Mohamed A. Kamal, Margee Louisias, Christine Xu, Matthew P. Kosloski   +8 more
wiley   +1 more source

CYP2C19 Genotype is Associated with Citalopram Treatment Outcomes in a Real‐World Setting

Clinical Pharmacology &Therapeutics, EarlyView.
CYP2C19 metabolizes various selective serotonin reuptake inhibitors (SSRIs) and genetic CYP2C19 variants are associated with SSRI tolerability and response. Yet, whether CYP2C19 variability also impacts citalopram response remained unclear. We here evaluated associations between CYP2C19 genotypes and citalopram prescription data of 11,079 patients from
Yoomi Park, Yitian Zhou, Volker M. Lauschke   +2 more
wiley   +1 more source

Market Perceptions of ESG Reputational Risk in the US Pharmaceutical Industry

Corporate Social Responsibility and Environmental Management, EarlyView.
ABSTRACT Negative ESG‐related reputational events generate significant corporate risks, particularly within sensitive sectors such as the pharmaceutical industry. Using novel reputational data, this research investigates investor perceptions of the consequences of experienced ESG breaches among US pharmaceutical firms.
Erdinc Akyildirim, Shaen Corbet, Jose Antonio Muñiz, Frank Scrimgeour   +3 more
wiley   +1 more source

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Paring down the placebo response

Nature Reviews Drug Discovery, 2016
Pivotal trials of Alkermes's antidepressant ALKS 5461 show how a patented clinical trial design might be able to help control problematic placebo responses. Pivotal trials of Alkermes's antidepressant ALKS 5461 show how a patented clinical trial design might be able to help control problematic placebo responses.
openaire   +4 more sources