125459 [ORIGINAL 2024]
: 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
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 : Determining where the therapeutic gene goes in
Guideline on the Non-Clinical Studies Required before First ... - EMA 125459
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