{"id":"W3174092070","doi":"10.52711/0974-360x.2021.00600","title":"Regulatory Strategies for Orphan drug Development in USA–Europe","year":2021,"lang":"en","type":"article","venue":"Research Journal of Pharmacy and Technology","topic":"Neurogenetic and Muscular Disorders Research","field":"Medicine","cited_by":1,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Orphan drug; Medicine; Approved drug; The Internet; Malaria; Family medicine; Drug; Biotechnology; Pharmacology; Bioinformatics; Biology; Computer science; World Wide Web; Pathology","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":"codex-gemma-dda1882f352a","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.001349526,0.00007805473,0.0002366766,0.0008159291,0.00009547563,0.00002704837,0.0001474996,0.00004863103,0.0001045299],"category_scores_gemma":[0.0004193433,0.00006522671,0.00003899173,0.0008086238,0.000276949,0.00008153077,0.0001335165,0.0007067725,0.000006035066],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00004237265,"about_ca_system_score_gemma":0.002110084,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.000003001568,"about_ca_topic_score_gemma":0.00002614146,"domain_scores_codex":[0.9985541,0.0001351763,0.0003184807,0.0001725699,0.0004365902,0.0003831596],"domain_scores_gemma":[0.9984725,0.0001158931,0.00005003259,0.0001324038,0.001091747,0.0001374076],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"bench_or_experimental","study_design_gemma":"bench_or_experimental","study_design_scores_codex":[0.001012706,0.0008999655,0.06759897,0.0007782806,0.0002628319,0.004500263,0.0004832982,0.000005517506,0.6235558,0.0178888,0.004025264,0.2789884],"study_design_scores_gemma":[0.007309892,0.0003751934,0.005800825,0.0001972063,0.00002285706,0.001939144,0.001869561,0.00009272048,0.4970501,0.004255375,0.4809722,0.0001148808],"study_design_candidate":"bench_or_experimental","study_design_consensus":"bench_or_experimental","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9821436,0.009845254,0.0001579375,0.006901695,0.00003785301,0.0002490886,6.306478e-7,0.000005264164,0.0006586291],"genre_scores_gemma":[0.9933982,0.00358762,0.001686667,0.0000589426,0.00004461882,0.00001762225,0.000001172807,0.00001386507,0.001191267],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.4769469,"threshold_uncertainty_score":0.3743198,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.07763742896815991,"score_gpt":0.4296040924753615,"score_spread":0.3519666635072016,"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."}}