Health Canada has announced the implementation of guideline S12 on nonclinical biodistribution considerations for gene therapy.
The guideline according to ICH
- Provides harmonized recommendations for the conduct of nonclinical biodistribution (BD) studies in the development of gene therapy (GT) products;
- Includes recommendations to facilitate the development of GT products while avoiding unnecessary use of animals, in accordance with the 3Rs (reduce/refine/replace) principles;
- Makes recommendations for the overall design of nonclinical BD assessments.
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