-д хадгалсан:
| Үндсэн зохиолчид: | , , , , , , |
|---|---|
| Формат: | Recurso digital |
| Хэл сонгох: | испани |
| Хэвлэсэн: |
Zenodo
2025
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| Нөхцлүүд: | |
| Онлайн хандалт: | https://doi.org/10.5281/zenodo.17148455 |
| Шошгууд: |
Шошго нэмэх
Шошго байхгүй, Энэхүү баримтыг шошголох эхний хүн болох!
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Агуулга:
- <p><strong>Abstract</strong><br>Topical ocular drugs face specific challenges for biopharmaceutical evaluation due to the anatomical and physiological barriers of the anterior segment. Despite increasing research, the available information is dispersed and lacks an integrated synthesis that organizes pharmacokinetic, physicochemical, formulation, and physiological criteria. This scoping review aims to map the scientific and regulatory literature related to these parameters in order to generate a solid evidence base for research applications.</p> <p><strong>Methods</strong><br>The review will follow the PRISMA-ScR guideline and the Arksey and O’Malley methodological framework. Structured and reproducible search strategies will be conducted in PubMed/MEDLINE, Scopus, and Web of Science. Complementary sources will include editorial platforms (ScienceDirect, SpringerLink, Taylor & Francis) and regulatory documents from international agencies (FDA, EMA, ICH, OECD, USP). Eligible evidence will include in vitro, ex vivo, in vivo studies, PBPK/PBBM models, and in silico simulations. Three independent reviewers will perform blinded screening of titles, abstracts, and full texts in Rayyan, with documented justifications for exclusions. Data extraction will be organized in comparative tables according to four axes: regulatory and pharmacokinetic determinants, physicochemical properties, formulation parameters, and physiological determinants.</p> <p><strong>Ethics and dissemination</strong><br>This protocol does not require ethical approval, as it does not involve human or animal subjects. Findings will be disseminated through a scientific publication, the consolidation of a structured database, academic presentations, and deposition of the protocol and its outputs in Zenodo to ensure open access and traceability.</p>