Part 3: need for, type and design of invitro and in vivo tumourigenicity studies
Available in vivo study, Reason for absence (not necessary, planned, requested, not necessary but justification required, not mentioned); Homologous model (not (known), yes, both homologous and heterologous); Dose of 10^5; Dose of 10^6; Dose of 10^7, RoA subcutaneous, RoA other (specified); Duration 0-3 months; Duration 3-6 months; Duration 6+ months; Presence Integration site analysis; Tumor formation (no, yes of human origin, yes of animal origin, unknown); Relevance (no, yes); Available In vitro studies (no, yes, requested, not mentioned); Karyotyping; Colony formation/Proliferation; Genomic analysis (transcriptional/epigenetic/SNP/microarray, telomere length); Immortalization (IVIM, senescence, apoptosis); Other (specified); In vivo and In vitro present (only in vivo, only in vitro , both, neither performed, not mentioned); Informativeness total package (no, partially, yes, not discussed), Reason for regarded informative (specified)