{"id":"W2063895202","doi":"10.4155/bio.13.1","title":"Analytical and Bioanalytical Assay Challenges to Support Comparability Studies for Biosimilar Drug Development","year":2013,"lang":"en","type":"editorial","venue":"Bioanalysis","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":33,"is_retracted":false,"has_abstract":false,"ca_institutions":"Intertek (Canada)","funders":"","keywords":"Biosimilar; Biopharmaceutical; Comparability; Business; Pharmacology; Biotechnology; Medicine; Biology","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":[0.0434844,0.003772341,0.004475345,0.003427248,0.004001616,0.01172207,0.006424111,0.03048814,0.005016875],"category_scores_gemma":[0.09075815,0.001827071,0.003965205,0.001635858,0.005894256,0.006683111,0.002787647,0.05002072,0.004837086],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.004707771,"about_ca_system_score_gemma":0.008342967,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.002933434,"about_ca_topic_score_gemma":0.00904459,"domain_scores_codex":[0.9695425,0.006778376,0.004474769,0.002236631,0.01592038,0.001047379],"domain_scores_gemma":[0.8591617,0.06727415,0.005987125,0.003597572,0.05545105,0.008528252],"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":[0.00003505985,0.00002241294,0.00003567931,0.0001960871,0.00003766905,0.0001103638,0.0000216761,0.00003564319,0.00008208867,0.0004676601,0.9904355,0.008520199],"study_design_scores_gemma":[0.0001109673,0.0000668243,0.0004991207,0.0006352522,0.0001512625,0.0004326902,0.00007244902,0.0004635454,0.0002772031,0.003115133,0.994127,0.00004844585],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"editorial","genre_gemma":"editorial","genre_scores_codex":[0.00005241566,0.006064259,0.0006511382,0.05971819,0.9324893,0.00002969899,0.00004294826,0.00008550589,0.0008665171],"genre_scores_gemma":[0.000644386,0.003293392,0.001043327,0.04524198,0.9443964,0.00004186874,0.00003763749,0.00007111192,0.005229849],"genre_candidate":"editorial","genre_consensus":"editorial","teacher_disagreement_score":0.0434844,"threshold_uncertainty_score":0.2299703,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.08291979931937664,"score_gpt":0.3721319578502333,"score_spread":0.2892121585308566,"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."}}