BD is the in vivo distribution, persistence, and clearance of a gene therapy (GT) product at the site of administration and in target and non-target tissues, including biofluids (e.g., blood, cerebrospinal fluid, vitreous fluid).
Nonclinical studies for BD assessment can be conducted as stand-alone BD studies or in conjunction with nonclinical pharmacology and toxicology studies. Therefore, in this document the term “BD study” represents either scenario.
For biodistribution study, animals are sacrificed in predetermined intervals and dissected to collect organs and tissues. Drug contents in organs and tissues are then detected to draw drug concentration versus time curves in corresponding tissues and organs.
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