{"id":"W4312468772","doi":"10.1007/978-3-031-10691-0_7","title":"Regulatory Documents for IND to Support FIH","year":2022,"lang":"en","type":"book-chapter","venue":"","topic":"Science, Research, and Medicine","field":"Medicine","cited_by":0,"is_retracted":false,"has_abstract":false,"ca_institutions":"University of British Columbia","funders":"","keywords":"Business","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.006150595,0.0006898012,0.00057724,0.001977736,0.003809968,0.006656062,0.002612609,0.0129309,0.1392538],"category_scores_gemma":[0.01449257,0.0006702416,0.0009017066,0.001280666,0.001986113,0.004180374,0.002427988,0.008126834,0.06875943],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.003817077,"about_ca_system_score_gemma":0.009373461,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.01081855,"about_ca_topic_score_gemma":0.02187048,"domain_scores_codex":[0.9955201,0.0007632519,0.0001623233,0.0003270681,0.002654076,0.0005731805],"domain_scores_gemma":[0.9936216,0.003167585,0.0002432918,0.0005514839,0.002085326,0.0003306763],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0000182791,0.0000953948,0.0001099186,0.0001008831,0.000003475591,0.0001080579,0.0002204577,0.0001144046,0.000309277,0.181403,0.7697025,0.04781433],"study_design_scores_gemma":[0.000006577948,0.00001130781,0.0002228561,0.000119774,0.000003075505,0.00009279991,0.00005658717,0.00007596185,0.0001585955,0.009069439,0.9901722,0.00001088832],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"other","genre_scores_codex":[0.0003858449,0.001681161,0.00178197,0.009156609,0.002137081,0.0001572623,0.0003135336,0.0003275088,0.984059],"genre_scores_gemma":[0.002932741,0.0009153937,0.002105326,0.01169771,0.0006756868,0.0001898383,0.0002427258,0.0001520524,0.9810885],"genre_candidate":"other","genre_consensus":"other","teacher_disagreement_score":0.1392538,"threshold_uncertainty_score":0.4658505,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.06076803872569115,"score_gpt":0.3714282604093775,"score_spread":0.3106602216836864,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}