Results 121 to 130 of about 104,914 (293)

Advances in Human Mass Balance Studies: An IQ Consortium Perspective on Current Practices and Emerging Trends

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Human radiolabeled mass balance studies are crucial for comprehensively characterizing the absorption, distribution, metabolism, and excretion (ADME) of investigational drugs, providing essential data for drug development, regulatory evaluation, and product labeling.
Jason Boer   +24 more
wiley   +1 more source

Safety, Tolerability, and Pharmacokinetics of GMDTC for Cadmium Poisoning: A Randomized Phase 1a/1b Trial

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Cadmium exposure causes serious health consequences; however, there is no clinically approved antidote for cadmium poisoning. This Phase 1a/1b trial aimed to investigate safety, tolerability, and pharmacokinetics of Sodium (S)‐2‐(dithiocarboxylato((2S,3R,4R,5R)‐2,3,4,5,6‐pentahydroxyhexyl) amino)‐4‐(methylthio) butanoate (GMDTC), a novel chelating ...
Xuefeng Ren   +21 more
wiley   +1 more source

Intravenous Lipopolysaccharide Challenge in Healthy Participants Reveals Pharmacodynamic Markers in Blood and Bone Marrow for Early‐Phase Oncology Drug Development

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Demonstrating pharmacological effects in early‐phase oncology clinical trials remains challenging, largely due to the lack of robust pharmacodynamic markers. Lipopolysaccharide (LPS) is used as an immune challenge agent in healthy participants to study drugs for autoimmune conditions.
Igor Radanović   +11 more
wiley   +1 more source

Registered Clinical Trials of Ayahuasca and DMT: A Scoping Review

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Interest in ayahuasca and its main component, N,N‐Dimethyltryptamine (DMT), has currently moved from historical and experimental use into modern clinical development. Yet, current evidence is fragmented, and systematic mapping of trial methods and design choices remains limited.
Tijana Stojanović   +4 more
wiley   +1 more source

Possibilities of adaptive design implementation in clinical trials of next-in-class drugs

open access: yesРегуляторные исследования и экспертиза лекарственных средств, 2018
The article investigates the possibility of streamlining the methodology of clinical studies of next-in-class drugs by implementing an adaptive design. Next-in-class drugs are original drugs with known biological targets, similar in structure and mode of
N. V. Vostokova   +3 more
doaj  

A Systematic Review on Disease‐Modifying Therapies in Parkinsonian Disorders

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Parkinsonian disorders, including Parkinson's disease, Lewy body dementia, multiple system atrophy, and progressive supranuclear palsy, are progressive neurodegenerative conditions with no treatment options to slow disease progression. This systematic review provides an overview of evidence of disease‐modifying therapies that have been evaluated in ...
Pepijn P.N.M. Eijsvogel   +3 more
wiley   +1 more source

Understanding Disease Heterogeneity and Patient Characteristics in Patients with Amyotrophic Lateral Sclerosis (ALS) [PDF]

open access: yes, 2019
Background: Amytrophic lateral sclerosis (ALS) is a fatal neurologic disease that is projected to double in worldwide incidence in the next 20 years.
Mathew, Veena
core  

Flow cytometry‐based monitoring of chimeric antigen receptor (CAR) T cells: Reagent selection, assay design, and clinical utility

open access: yesCytometry Part B: Clinical Cytometry, EarlyView.
Abstract Accurate quantification of chimeric antigen receptor (CAR) T cells is essential for monitoring post‐infusion CART expansion and persistence and for real‐time clinical decision‐making. Multiparameter flow cytometry (MFC) enables rapid, live‐cell detection with absolute quantification and concurrent immunophenotypic characterization. This review
Jianhua Ling, Wei Wang, Sa A. Wang
wiley   +1 more source

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