Results 31 to 40 of about 5,649 (188)
AIChE Journal, EarlyView.Abstract Generating hydrogel beads pertains to many engineering applications. We examined two alginate‐based fluids at three concentrations of alginate, cAG$$ {c}_{\mathrm{AG}} $$. We used the “Map of Misery” to determine which material property (viscosity, elasticity, and inertia) drives droplet formation.
Conor G. Harris +5 more
wiley +1 more source
The Anatomical Record, EarlyView.Abstract Hadrosaurid dinosaurs are generally regarded as “crested” or “non‐crested” depending on the presence or absence of a bony cranial crest. At least one supposedly “non‐crested” hadrosaur is known to have possessed a soft tissue cranial crest (or comb), based on an exceptionally preserved “mummified” specimen. Here we redescribe this specimen and
Henry S. Sharpe +4 more
wiley +1 more source
British Journal of Clinical Pharmacology, EarlyView.With multiple disease‐modifying therapies now available, treatment switching has become an important clinical consideration in the management of spinal muscular atrophy (SMA). While some switches are prompted by suboptimal clinical response, more commonly they are driven by treatment burden, convenience, or adverse events.
Andrej Belančić +4 more
wiley +1 more source
Real-world evidence for regulatory decision-making: updated guidance from around the world
Frontiers in Medicine, 2023 Leveraging the value of real-world evidence (RWE) to make informed regulatory decisions in the field of health care continues to gain momentum. Improving clinical evidence generation by evaluating the outcomes and patient experiences at the point-of-care
Leah Burns +7 more
doaj +1 more source
British Journal of Clinical Pharmacology, EarlyView.Abstract Despite regulatory progress being made in the past two decades, off‐label drug use in paediatrics remains pervasive, with prevalence estimated between 3% and 97% of prescriptions across different clinical settings. Off‐label use—defined as prescribing outside the conditions described in the Summary of Product Characteristics (SmPC)—is often ...
Tjitske M. van der Zanden +3 more
wiley +1 more source
British Journal of Clinical Pharmacology, EarlyView.Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola +5 more
wiley +1 more source
Clinical Pharmacology &Therapeutics, EarlyView.With the increasing volume of clinical evidence derived from large‐scale Asian real‐world data (RWD) and the growing interest in its use in regulatory decision‐making, it is important to conduct benchmarking exercises that evaluate whether studies using Asian RWD can generate similar conclusions as randomized controlled trials (RCTs).
Hwa Yeon Ko +15 more
wiley +1 more source
Journal of Comparative Effectiveness Research, 2023 Aim: To evaluate the availability of published comparative real-world evidence (RWE) studies in Medicare patients for the ten drugs set to undergo Centers for Medicare and Medicaid Services (CMS) price negotiations in 2026.
Ashley Jaksa +2 more
doaj +1 more source
Real-world data: principles of use in decision making and in health technology assessment
Фармакоэкономика, 2023 The use of real-world data (RWD) and real-world evidence (RWE) in process of improving public health, their assessment, and use in decision making is a promising area.
V. V. Omelyanovskiy +7 more
doaj +1 more source
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 +8 more
wiley +1 more source