A vital aspect of clinical safety involves understanding the potential for vector shedding from the administered gene therapy. Evaluation of biofluids informs understanding of private and environmental risks and can also be a recommended part of preclinical development. Insufficient safety data could lead on to regulatory approval challenges and delay time on the clinic.
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Uptake by non-target tissues is common, risking patient safety and therapeutic effectiveness. Biodistribution studies are conducted during preclinical development To guage how gene therapies are taken up and retained in vivo
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