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)