125459 Site

: Determining where the therapeutic gene goes in the body and how long it persists in both target and non-target cells.

The guideline, officially titled , provides a framework for non-clinical studies required before a gene therapy can be used in human clinical trials. Guide to EMA Guideline 125459 125459

Guideline on the Non-Clinical Studies Required before First ... - EMA : Determining where the therapeutic gene goes in

: Characterizing potential immune responses to the viral vector or the new protein produced by the therapy. 125459

For more detailed technical specifications, you can access the full Guideline on Non-Clinical Studies for GTMPs via the official .