Vol. 8 No. 08 (2026): Volume 08 Issue 08

Biologically active substances of woad (Isatis tinctoria), such as flavonoids, vitamins, and polysaccharides, have been studied. It was found that the dry extract obtained from the leaves of woad contains vitamins C, B₂, and PP, as well as the flavonoids dihydroquercetin, quercetin, and rutin. The total polysaccharide content in the studied extract was also determined and amounted to 11.07%.

The obtained data allow us to conclude that the dry aqueous extract obtained from the leaves of woad contains vitamins C, B₂, and PP, as well as the flavonoids dihydroquercetin, quercetin, and rutin, which indicates that the dry extract possesses antioxidant, antiviral, anti-inflammatory, vasodilatory, and other properties. Furthermore, the polysaccharide content in the studied extract was identified. The total polysaccharide content amounted to 11.07%.

Protocol deviations in inherited retinal disease (IRD) ophthalmology trials represent a multifaceted operational challenge threatening participant safety and primary endpoint data integrity (Getz, 2011; Cilley, 2025). These deviations span imaging acquisition, functional testing, investigational product handling, and visit scheduling. Unlike conventional pharmacological trials, IRD gene therapy involves irreversible surgical interventions where deviations cannot be recovered through repeat visits (Russell, 2017).

This article presents a comprehensive framework for classifying protocol deviation types in IRD trials and identifies strategic intervention points enabling proactive prevention through structured pre-visit preparation and real-time escalation protocols.

The Procedure Criticality Checklist (PCC) system applies risk-based monitoring principles (International Council for Harmonization, 2023) by severity and implementing targeted prevention mechanisms. The framework integrates evidence from surgical safety science (Haynes, 2009), quality-by-design methodology (TransCelerate Biopharma, 2023), IRD trial operations literature (Thompson, 2020).

The framework comprises: (1) a deviation taxonomy, (2) criticality-stratified pre-visit checklists, (3) tiered escalation pathways with predefined decision authorities, and (4) electronic integration mechanisms real-time monitoring.

Implementation is anticipated to reduce preventable deviations, improve data integrity, strengthen regulatory submissions, and accelerate approval timelines for ATMP ophthalmology programs.

This framework addresses a critical gap in IRD trial operations by providing standardized, operationalizable deviation prevention methodology suitable for adoption across national research networks (Igoe, 2024).

Dry powder inhalers (DPIs) have become one of the most widely adopted pulmonary drug delivery systems because of their portability, propellant-free operation, formulation stability, and ability to deliver medications directly to the respiratory tract. Despite significant technological progress, conventional DPIs remain limited by their inability to objectively monitor patient adherence, inhalation technique, inspiratory flow variability, and real-time treatment outcomes. These limitations contribute to suboptimal disease control in chronic respiratory disorders such as asthma and chronic obstructive pulmonary disease (COPD). The rapid emergence of digital health technologies, including artificial intelligence (AI), Internet of Medical Things (IoMT), cloud computing, digital sensors, and mobile health platforms, has introduced new opportunities to transform conventional inhalation devices into intelligent therapeutic systems capable of continuous monitoring, personalized intervention, and data-driven clinical decision-making. This systematic review critically examines the current state of digital dry powder inhaler technologies by integrating evidence from recent developments in inhaler engineering, digital monitoring platforms, inhalation analytics, regulatory science, and patient-centered healthcare models.

The review synthesizes evidence from the selected literature to evaluate technological innovations in digital DPIs, including sensor-enabled adherence monitoring, inspiratory flow analysis, AI-assisted inhalation assessment, cloud-based healthcare integration, and remote disease management platforms. Particular attention is given to the evolving regulatory landscape governing digital inhalers, including device validation, software integration, cybersecurity, interoperability, clinical performance evaluation, and post-market surveillance. The review also explores challenges associated with technical standardization, patient usability, data privacy, economic feasibility, and clinical implementation. Comparative analysis demonstrates that digital integration significantly enhances treatment adherence, enables early identification of inhalation errors, supports personalized respiratory care, and improves healthcare efficiency while introducing new regulatory and implementation complexities. Recent investigations into digital inhaler platforms further demonstrate the growing importance of connected respiratory devices for long-term disease monitoring and adherence optimization (Aung et al., 2025).

The findings indicate that future DPI systems will increasingly evolve toward intelligent, connected, and predictive healthcare ecosystems supported by artificial intelligence, machine learning, remote patient monitoring, and real-time clinical analytics. Successful implementation, however, requires multidisciplinary collaboration among pharmaceutical scientists, device engineers, software developers, clinicians, regulatory authorities, and healthcare organizations. The review contributes a comprehensive synthesis of current developments while identifying future research priorities necessary for achieving safe, effective, and globally standardized digital inhaler technologies.