Results 191 to 200 of about 5,256,450 (257)
Regulatory harmonization: Evolution, globalization and future directions
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm +2 more
wiley +1 more source
Aims Golcadomide is a potential first‐in‐class oral CELMoD™ agent for the treatment of lymphoma. This study aims to develop model‐informed drug development (MIDD) approaches to support optimal dose selection of golcadomide in combination with immunotherapy rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R‐CHOP) in alignment with ...
Xirong Zheng +7 more
wiley +1 more source
Aims This study aimed to evaluate the acute effects of cannabidiol plus tetrahydrocannabinol (CBD+THC) and tetrahydrocannabinol (THC) oils on cardiovascular haemodynamics, respiratory muscle activity and peripheral tissue perfusion in healthy adults. Methods In this randomized, double‐blind, crossover trial, participants received orally administered ...
Edna Karla Ferreira Laurentino +9 more
wiley +1 more source
Hypertension in obesity represents a major global health challenge, closely linked to the global epidemics of obesity, type 2 diabetes and metabolic dysfunction. Excess adiposity contributes to elevated blood pressure through multiple, interrelated mechanisms, including activation of the renin–angiotensin–aldosterone system, sympathetic nervous system ...
Christina Antza +12 more
wiley +1 more source
Gabapentin as an add‐on analgesic to morphine in paediatric patients with chronic pain
Aims Off‐label use of gabapentin for the treatment of chronic pain in children has increased over the last decade, with multiple clinical trials evaluating its role pain management and potential opioid‐sparing effects. To date, however, these studies appear to rely on empirical evidence without further consideration of pharmacokinetic‐pharmacodynamic ...
Paul Healy +15 more
wiley +1 more source
Abstract Cyclizine is a long‐established, short‐acting drug, registered for preventing motion sickness, post‐operative nausea and vomiting (PONV) and ‘vomiting of known cause’. The latter is not defined but may include pregnancy and patients receiving palliative care, historically accepted without large, controlled trials.
Gareth J. Sanger, Paul L. R. Andrews
wiley +1 more source
Translational development of crisugabalin for neuropathic pain
Abstract Crisugabalin (HSK16149) is a next‐generation α2δ ligand developed to preserve the mechanistic rationale of gabapentinoids while refining target engagement and exposure‐related tolerability constraints. We performed a translational review of molecular/structural studies, in vivo pharmacology and behavioural safety assessments, phase I clinical ...
Rafael Batista João +5 more
wiley +1 more source
Economic evaluations of antiobesity medications: A systematic literature review
The global prevalence of obesity is rising rapidly. With several antiobesity medications approved and many more in development, understanding their economic value is increasingly important. This study reviews full economic evaluations of approved antiobesity medications to assess cost‐effectiveness and inform reimbursement and access decisions.
Martina Jurković +5 more
wiley +1 more source
Aims This study aimed to evaluate the safety, tolerability and pharmacokinetics of a novel oral modified‐release psilocybin formulation (REL‐P11) in normal‐weight and overweight/obese healthy adults and to assess its suitability for controlled, subperceptual exposure, in light of emerging evidence supporting serotonergic modulation in metabolic ...
Anna Signor +11 more
wiley +1 more source

