{"id":"W2042850239","doi":"10.4103/0975-7406.106569","title":"Biosimilars: Current regulatory perspective and challenges","year":2013,"lang":"en","type":"article","venue":"Journal of Pharmacy And Bioallied Sciences","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":3,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Biosimilar; Bioequivalence; Pharmacology; Medicine; Business; Pharmacokinetics; Internal medicine","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":[0.0009417583,0.000123927,0.0002346609,0.0001456316,0.0001953854,0.00005302798,0.0001849933,0.00005995263,0.0002578279],"category_scores_gemma":[0.00008058649,0.00007343882,0.00006211647,0.0001174384,0.001293964,0.0002743215,0.00006967927,0.0002611616,0.000006936859],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00001373112,"about_ca_system_score_gemma":0.00005418932,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00000951828,"about_ca_topic_score_gemma":0.000001934461,"domain_scores_codex":[0.9990643,0.0001621676,0.0002834932,0.0001990825,0.00007439176,0.0002165239],"domain_scores_gemma":[0.9993621,0.0001632086,0.0001947155,0.00005365142,0.0001573655,0.000068977],"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":[0.0001953467,0.0004551806,0.008320916,0.0001355908,0.0003403024,0.00001157088,0.001915193,6.283512e-7,0.3878304,0.01991348,0.009219271,0.5716621],"study_design_scores_gemma":[0.007516456,0.002848419,0.09435104,0.0004454528,0.0005677037,0.001918284,0.01741585,0.0002337602,0.2972121,0.04235386,0.5339194,0.001217707],"study_design_candidate":"bench_or_experimental","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.5416113,0.4217527,0.00003097602,0.03397812,0.0009409255,0.00015338,0.000005446671,0.00001349359,0.001513641],"genre_scores_gemma":[0.9538051,0.04477222,0.0008025739,0.0004607238,0.00009623006,0.000001365387,1.077159e-7,0.000003242638,0.00005842701],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.5704443,"threshold_uncertainty_score":0.4767663,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.09754136608418014,"score_gpt":0.3602832840119084,"score_spread":0.2627419179277283,"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."}}