Part 2: need for, type and design of in vivo biodistribution
studies
Available in vivo study, Reason for absence (not necessary,
planned, requested, not necessary but justification required, not
mentioned); Multiple studies performed (no, yes); Homologous model (not
(known), yes, both homologous and heterologous); Migration (target
tissues, both target and non-target tissues); Quantifiable method (no,
yes, not mentioned); Persistence studied (no, yes, planned, not
mentioned); Informative (no, yes); Informative for (PoC/MoA, Safety,
both)