: Determining where the therapeutic gene goes in the body and how long it persists in both target and non-target cells.
: This guideline is a cornerstone for developers of Advanced Therapy Medicinal Products (ATMPs) in the European Union. 125459
Guideline on the Non-Clinical Studies Required before First ... - EMA : Determining where the therapeutic gene goes in
: Checking if the patient might "shed" or spread the virus/vector through secretions. 125459
: Characterizing potential immune responses to the viral vector or the new protein produced by the therapy.