{"id":"W4390571917","doi":"10.22270/ijdra.v11i4.633","title":"A Review on Next Generation eCTD – eCTD v4.0","year":2023,"lang":"en","type":"review","venue":"International Journal of Drug Regulatory Affairs","topic":"Quality and Safety in Healthcare","field":"Health Professions","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Certification; XML; Process (computing); Business; Regulatory authority; Computer science; Information exchange; Product (mathematics); Accounting; World Wide Web; Political science; Telecommunications; Public administration; Law","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.002629569,0.0006598624,0.001337749,0.003168371,0.0003529007,0.001331712,0.001548364,0.001379993,0.01189927],"category_scores_gemma":[0.004067224,0.0003497621,0.001675918,0.002896653,0.0003783314,0.001702099,0.0009563732,0.001811397,0.004399135],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00130326,"about_ca_system_score_gemma":0.00475825,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.002237658,"about_ca_topic_score_gemma":0.005545692,"domain_scores_codex":[0.999135,0.0001865473,0.00016826,0.00008587261,0.0003535733,0.00007076951],"domain_scores_gemma":[0.9981604,0.000751857,0.0002494802,0.00005523446,0.0006607545,0.0001222419],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0000899781,0.00006060925,0.000132846,0.05413931,0.0001831802,0.0001379207,0.00008161166,0.0001799211,0.001119559,0.005092386,0.09803145,0.8407512],"study_design_scores_gemma":[0.00002149572,0.00006908846,0.0003171369,0.0112923,0.0002083217,0.0002746217,0.00002095125,0.0000230758,0.0002202489,0.0005846981,0.9869578,0.00001034324],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.000126348,0.9931062,0.0002916936,0.001484652,0.0007165784,0.00006001714,0.0001755309,0.000031189,0.004007838],"genre_scores_gemma":[0.0006922468,0.9945865,0.0006220458,0.001961195,0.000186038,0.00005495944,0.0002531157,0.000007791272,0.001636084],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.01189927,"threshold_uncertainty_score":0.03980702,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.3663792009933086,"score_gpt":0.5315893539655137,"score_spread":0.165210152972205,"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."}}