Division 5.2.1 Human pharmacokinetic studiesF1F2

Human pharmacokinetic studies shall include the following aspects:

1. (a)

   shedding studies to address the excretion of the gene therapy medicinal products;

2. (b)

   biodistribution studies;

3. (c)

   pharmacokinetic studies of the medicinal product and the gene expression moieties (e.g. expressed proteins or genomic signatures).