ICH S12 Non-clinical Biodistribution Studies for Gene Therapy

S12 Non-clinical Biodistribution Studies for Gene Therapy Products

S12 EWG Non-clinical Biodistribution Studies for Gene Therapy Products

This topic was endorsed by the ICH Assembly in June 2019.

The S12 EWG is working on the development of a new S12 Guideline on “Nonclinical Biodistribution Considerations for Gene Therapy Products”, with a view to providing recommendations on the elements of nonclinical studies performed that include Biodistribution assessment, and will contribute to the streamlined development of the Gene Therapy products, while maintaining scientific rigor and minimizing the unnecessary use of animals.
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Date of Step 2b: 3 June 2021

Status: Step 3

Guidelines (Click the links below for complete guidelines)



Endorsed Documents (Click the links below for complete guidelines)





WG Presentations/Trainings (Click the links below for complete guidelines)



*These Guidelines Belongs to ICH website.

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