保存先:
| 第一著者: | |
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| フォーマット: | Recurso digital |
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| 出版事項: |
Zenodo
2026
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| オンライン･アクセス: | https://doi.org/10.5281/zenodo.19851446 |
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- <p>Skin regeneration remains a critical challenge in dermatology, particularly for chronic wounds and burns. <em>Carthamus tinctorius</em> L. (Safflower), a plant rich in bioactive flavonoids and fatty acids, has shown significant potential in accelerating tissue repair. This study evaluates the efficacy of a pharmaceutical cream infused with <em>C. tinctorius</em> extract. Through biochemical analysis and histological observations, the research highlights the cream's ability to modulate inflammatory cytokines and promote collagen synthesis. The results suggest that safflower extract is a viable candidate for advanced wound-healing formulations.</p> <p><strong>Background:</strong> The integrity of modern pharmaceutical development rests upon a foundation of rigorous ethical and procedural frameworks. Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) represent the dual pillars that ensure the transition of a chemical entity from a laboratory concept to a safe therapeutic intervention.</p> <p> <strong>Objective:</strong> This study aims to analyze the critical role of GLP and GCP compliance as the primary safeguard for drug safety and efficacy within the global regulatory landscape.</p> <p><strong>Methods:</strong> A comprehensive systematic review was conducted, examining the International Council for Harmonisation (ICH) guidelines and comparative case studies of regulatory approvals and clinical failures. The analysis focuses on the bioethical implications of data integrity and subject protection.</p> <p><strong>Results:</strong> The findings demonstrate that adherence to GLP standards in non-clinical safety studies provides a reproducible toxicological profile, which is essential for risk assessment. Simultaneously, GCP compliance ensures the ethical treatment of human participants through robust Informed Consent processes and Institutional Review Board (IRB) oversight. Data suggests that deviations from these standards not only jeopardize patient safety but also lead to significant legal and financial repercussions for pharmaceutical organizations.</p> <p><strong>Conclusion:</strong> Bioethical standards are not merely administrative requirements but are essential moral and scientific imperatives. Strengthening the global harmonization of GLP and GCP is vital for maintaining public trust in the healthcare system and ensuring that only high-quality, evidence-based medicines reach the market.</p> <p> </p>