Part 2: Elements scored regarding biodistribution studies
Availability in vivo study (no, yes); Reason for absence of the
study (not necessary, planned, requested, not necessary but
justification required, not mentioned); Analysis (clinical,
non-clinical) Species used (specified); Animal model used (healthy,
disease model, immune-compromised); Dose used (specified); Method for
labelling and detection (specified); Sampling time points (specified);
Site of Administration (specified); 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/Mechanism of Action (MoA),
Safety, both)