AI Article Synopsis
- The guideline aims to establish basic standards for the creation, maintenance, and quality control of human lung organoids used in research for testing respiratory system health.
- It serves as a foundational resource for developing alternative testing methods that can be used in various contexts such as research, clinical, and commercial applications.
- Regulatory experts and researchers can also reference this guideline to evaluate the safety and efficacy of products related to lung health.
Article Abstract
The objective of standard guideline for utilization of human lung organoids is to provide the basic guidelines required for the manufacture, culture, and quality control of the lung organoids for use in non-clinical efficacy and inhalation toxicity assessments of the respiratory system. As a first step towards the utilization of human lung organoids, the current guideline provides basic, minimal standards that can promote development of alternative testing methods, and can be referenced not only for research, clinical, or commercial uses, but also by experts and researchers at regulatory institutions when assessing safety and efficacy.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11170115 | PMC |
| http://dx.doi.org/10.15283/ijsc24041 | DOI Listing |
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