The number most commonly refers to a specific scientific guideline established by the European Medicines Agency (EMA) regarding the development of Gene Therapy Medicinal Products (GTMPs) .
This document outlines the essential safety and efficacy data that developers must generate during the "non-clinical" (animal or lab) phase to justify moving into human subjects. 125459
For more detailed technical specifications, you can access the full Guideline on Non-Clinical Studies for GTMPs via the official . The number most commonly refers to a specific
: Determining where the therapeutic gene goes in the body and how long it persists in both target and non-target cells. 125459