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.
A Step 4 Introductory Training Presentation has been developed by the S12 EWG to summarise the content of the Guideline.
Further information can be found on the S12 page, including the Guideline and the Step 4 Introductory Training Presentation available for download.
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