ICH – The ICH S12 Guideline reaches Step 4 of the ICH Process
The ICH S12 Guideline on “Nonclinical Biodistribution Considerations for Gene Therapy Products” has reached Step 4 of the ICH Process on 14 March 2023.
This Guideline is intended to provide guidance on the conduct of nonclinical biodistribution (BD) studies in the development of gene therapy (GT) products that mediate their effect by the expression (transcription or translation) of transferred genetic materials, and harmonised recommendations to facilitate the development of GT products while avoiding unnecessary use of animals, in accordance with the 3Rs (reduce/refine/replace) principles.
More information on the ICH Website.
OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (9 mai 2023). ICH – The ICH S12 Guideline reaches Step 4 of the ICH Process. ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/o6a5





