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
Rapid Pre-Implementation Evaluation for Multi-Specialty Surgical Trials: Informing Context-Specific Adaptations. [PDF]
Sasnal M +6 more
europepmc +1 more source
Precision medicine in paediatrics: Progress and priorities
Precision medicine is revolutionizing personalized healthcare, advancing both diagnostics and therapeutics at an unprecedented pace. Reviewing the paediatric applications of pharmacometrics, pharmacogenomics and advanced therapy medicinal products highlights not only the relevance of these exciting innovations to frontline care but also the significant
Nicola Husain +3 more
wiley +1 more source
Optimizing Heart Failure-Specific Disease Management Programs and Patient Care in Saudi Arabia: A Saudi Heart Association Position Statement. [PDF]
Bakhsh A +9 more
europepmc +1 more source
Aims The Black Triangle Scheme, introduced in 2018 in Australia, does not appear to have increased the quantity of adverse drug event (ADE) reports. This study evaluated healthcare professionals' (HCPs') and consumers' awareness of the scheme, its influence on intentions for future ADE reporting, and suggested improvements.
Eyob Alemayehu Gebreyohannes +7 more
wiley +1 more source
Clinical Trials in Older Adults with Cardiovascular Multimorbidity: A Perspective on Pragmatic Trial Design. [PDF]
Bonanad C +16 more
europepmc +1 more source
Capacity building in medicines development and regulation in Africa—Overview on recent progress
Aims Despite advances in health research and digital innovation, many African countries continue to face substantial resource constraints, fragmented capacity‐building efforts and a shortage of skilled professionals in medicines development and regulatory science.
Tirhani Maluleke +7 more
wiley +1 more source
Host-state biomarkers and clinical factors for stratification and optimization of cell therapy trials in chronic limb-threatening ischemia: A review. [PDF]
Shimizu Y +8 more
europepmc +1 more source
Lifecycle perspective on cell and gene therapy manufacturing challenges and enabling GMP solutions. ABSTRACT Cell and gene therapies (CGTs) are revolutionizing modern medicine; however, making these advanced medicines scalable and readily available to commercial manufacturers worldwide is a major challenge. The number of approved CGT products continues
Rajath Samaga +2 more
wiley +1 more source
Artificial Intelligence in Nuclear Medicine (2015-2025): Clinical Applications, Regulatory Governance, and Pharmacotherapeutic Implications. [PDF]
Alpizar-Rojas M +6 more
europepmc +1 more source

