{"id":"W1980543089","doi":"10.1016/j.nucmedbio.2014.09.011","title":"Preclinical pharmacokinetics, biodistribution, radiation dosimetry and acute toxicity studies required for regulatory approval of a Clinical Trial Application for a Phase I/II clinical trial of 111In-BzDTPA-pertuzumab","year":2014,"lang":"en","type":"article","venue":"Nuclear Medicine and Biology","topic":"HER2/EGFR in Cancer Research","field":"Medicine","cited_by":18,"is_retracted":false,"has_abstract":false,"ca_institutions":"Juravinski Cancer Centre; University Health Network; McMaster University; Ontario Institute for Cancer Research; University of Toronto","funders":"Ontario Institute for Cancer Research","keywords":"Biodistribution; Clinical trial; Pharmacokinetics; Dosimetry; Medicine; Pharmacology; Regulatory authority; Medical physics; Toxicity; Oncology; Nuclear medicine; Internal medicine; In vivo; Biotechnology; Biology","routes":{"ca_aff":true,"ca_fund":true,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":["metaresearch"],"consensus_categories":[],"category_scores_codex":[0.007207821,0.0001935312,0.001550684,0.0001296725,0.000106331,0.00000296504,0.0001386739,0.0004110413,0.0000167002],"category_scores_gemma":[0.01253006,0.0001390684,0.0002454633,0.0001522605,0.001986936,0.00003466249,0.000105924,0.0003087801,6.346785e-7],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00003963499,"about_ca_system_score_gemma":0.0002102684,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00001687564,"about_ca_topic_score_gemma":0.000002197256,"domain_scores_codex":[0.9961797,0.0004995251,0.002179612,0.0006389214,0.0002154271,0.0002867858],"domain_scores_gemma":[0.9949187,0.003236878,0.0007560025,0.0003862962,0.0004599802,0.0002421292],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"randomized_trial","study_design_gemma":"randomized_trial","study_design_scores_codex":[0.514295,0.001772894,0.0008367102,0.0004649104,0.000719185,5.730553e-7,0.0001876211,5.44181e-8,0.01415806,0.001201397,0.01290898,0.4534546],"study_design_scores_gemma":[0.7362436,0.1446258,0.001031149,0.0001543037,0.001421727,0.00001348185,0.000203258,0.004062719,0.002069089,0.001030442,0.1089474,0.0001970699],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9863771,0.0009773214,0.001883564,0.005184374,0.001042728,0.004322307,0.000150919,0.00003100974,0.00003067976],"genre_scores_gemma":[0.9909993,0.002619568,0.001390885,0.0007191867,0.003830811,0.0001655268,0.0002193683,0.00002455093,0.00003076796],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.4532575,"threshold_uncertainty_score":0.9957878,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.3390109953650138,"score_gpt":0.5810161384611477,"score_spread":0.242005143096134,"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."}}