Despite significant breakthroughs in longevity technology in recent years, there is still a long way to go from laboratory achievements to safe and effective market-oriented applications. This mainly revolves around three core aspects:
CLINICAL TRANSLATION SAFETY VALIDATION: Safety is of utmost importance. Strict preclinical toxicological studies must be conducted on animal models before human trials;
Clinical trials: Multi-phase human clinical trials are required to further confirm the safety and efficacy of the drug. The data from this phase serve as the core basis for submitting applications to regulatory agencies for marketing approval.
Regulatory Compliance: The current approval framework of global drug regulatory agencies, such as the FDA in the United States, is targeted at therapeutic drugs for specific diseases, rather than preventive interventions for the fundamental process of aging. R&D companies need to engage in extensive preliminary communication with regulatory agencies to explore new approval pathways.
To ultimately prove that an intervention measure can truly extend human "healthy lifespan" "Life", short-term and small-scale research is far from sufficient. This requires research Fundamental transformation of paradigm:
Multi-center study: Recruitment at multiple research centers across different regions and ethnic groups Recruit subjects to reduce potential biases that may exist in a single center and ensure the research results are valid It is suitable for a wider range of people;