Results 111 to 120 of about 104,915 (286)

Revisiting the Ethics of Urate‐Lowering Therapy Clinical Trials for Gout Management

Arthritis &Rheumatology, EarlyView.
Lisa K. Stamp, Dien Ho, Nicola Dalbeth
wiley   +1 more source

The evolving therapeutic landscape of spinal muscular atrophy – A scoping review of investigational agents, emerging delivery technologies and strategic innovations

British Journal of Clinical Pharmacology, EarlyView.
Spinal muscular atrophy (SMA) is a severe neuromuscular disease with emerging therapeutic complexity. This review aims to systematically map the global pipeline of investigational treatments for SMA. Using ClinicalTrials.gov and complementary international registries, we identified 21 planned or ongoing interventional trials from 2020 to 2025 targeting
Andrej Belančić, Patrick Eustaquio, Elvira Meni Maria Gkrinia, Ivana Stević, Eugen Javor, Yun Wah Lam, Slobodan Janković, Dinko Vitezić   +7 more
wiley   +1 more source

Do Physicians Have a Duty to Discuss Expanded Access to Investigational Drugs with their Patients? A Normative Analysis. [PDF]

J Law Med Ethics, 2023
Vermeulen SF, Hordijk M, Visser RJ, Bunnik EM.   +3 more
europepmc   +1 more source

Early clinical pharmacology evaluation of the novel anti‐inflammatory macrolide, glasmacinal (EP395): tolerability, pharmacokinetics and drug interactions

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims This work assessed the pharmacokinetics (PK), safety and tolerability of glasmacinal (EP395, an oral anti‐inflammatory macrolide with negligible antimicrobial activity in development for COPD treatment) in two healthy participant trials: ‘first‐in‐human’ (FIH) and ‘drug–drug‐interaction’ (DDI).
Dave Singh, Kate Hanrott, Olof Breuer, Johan Bylund, Björn Schultze, Virginia Norris   +5 more
wiley   +1 more source

Exposure‐adjusted safety and efficacy of GLP‐I and GLP‐1/GIP receptor agonists compared with non‐GLP‐I for weight management and type 2 diabetes: Based on FDA medical and statistical reports of 34 280 safety and 36 312 efficacy subjects

British Journal of Clinical Pharmacology, EarlyView.
Aims This work aimed to contextualize glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) and glucose‐dependent insulinotropic polypeptide (GIP) receptor agonists safety and efficacy regarding weight management (WM); we analysed Food and Drug Administration (FDA) Medical Reviews to analyse 14 medications using patient‐exposure year normalization and ...
Aishwarya Prasad, Anshu Arora, Arun Arora, Jeena Vaid, Arif Khan   +4 more
wiley   +1 more source

Navigating Drug–Drug Interactions in Clinical Drug Development: A Tutorial

Clinical and Translational Science
This tutorial provides essential guidelines and insights, in addition to regulatory guidance, for the evaluation of drug–drug interactions (DDIs), with a focus on the tools and timing of assessment critical for effective management of inclusion/exclusion
Jesmin Lohy Das, Antoinette (Toni) Ajavon‐Hartmann, Virginia (Ginny) D. Schmith   +2 more
doaj   +1 more source

Experimental and Investigational Pharmacotherapy for Psoriatic Arthritis: Drugs of the Future

Journal of Experimental Pharmacology, 2020
Luca Navarini,1,* Damiano Currado,1,* Luisa Costa,2 Marco Tasso,2 Maria Sole Chimenti,3 Francesco Caso2 1Unit of Rheumatology, Immunology and Clinical Medicine, Università Campus Bio-Medico Di Roma, Rome, Italy; 2Rheumatology Unit, Department of ...
Navarini L, Currado D, Costa L, Tasso M, Chimenti MS, Caso F   +5 more
doaj  

The 'false hope' argument in discussions on expanded access to investigational drugs: a critical assessment. [PDF]

Med Health Care Philos, 2022
Hordijk M, Vermeulen SF, Bunnik EM.
europepmc   +1 more source

A Mathematical Approach to Comply with Ethical Constraints in Compassionate Use Treatments

, 2018
Patients who are seriously ill may ask doctors to treat them with unapproved medication, about which not much is known, or else with known medication in a high dosage. Apart from strict legal constraints such cases may involve difficult ethical questions
Bruss, F. Thomas
core  

Regulating Innovative Medicine: Fitting Square Pegs in Round Holes [PDF]

, 2005
Increasingly, innovative medical products are creating a quandary for the Food and Drug Administration ( FDA ) because they often transcend the FDA\u27s traditional categorical approach to regulating medical products. In a recent attempt to simplify this
Lavender, Mark
core   +1 more source