Determining the Need for and Content of Enviromental Sssessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products (2015)
EMA
Scientific Requirements for the Enviromental Risk Assessment of Gene Therapy Medicinal Products (2006)
遺伝子治療用製品のFirst in Humanのまための非臨床試験
FDA
Preclinical Assessment of Investigational Cellular and Gene Therapy Products (2013)
EMA
Non-clinical studies required before first clinical use of gene therapy medicinal products (2008)
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