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Publication of a Reflection Paper on Expectations for Biodistribution (BD) Assessments for Gene Therapy (GT) Products
The IPRP Gene Therapy Working Group is pleased to announce the publication of a Reflection Paper on Expectations for Biodistribution (BD) Assessments for Gene Therapy (GT) Products.
Its purpose is to communicate the current thinking of Experts from various International Regulatory Authorities with respect to the relevance of and need for non-clinical BD assessments during the development of GT products, in order to support clinical trials and marketing authorization applications.
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