{"id":"W2088499232","doi":"10.1016/j.biologicals.2011.06.006","title":"Statistical considerations for confirmatory clinical trials for similar biotherapeutic products","year":2011,"lang":"en","type":"review","venue":"Biologicals","topic":"Statistical Methods in Clinical Trials","field":"Mathematics","cited_by":20,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada","funders":"Health Canada","keywords":"Equivalence (formal languages); Clinical trial; Medicine; Product (mathematics); Computer science; Risk analysis (engineering); Mathematics; Pathology","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":"metacan-v3-hybrid-931329e0061c","candidate_categories":["metaresearch"],"consensus_categories":["metaresearch"],"category_scores_codex":[0.5530306,0.002322285,0.009915822,0.005711337,0.001317831,0.007560446,0.006009682,0.008799751,0.00925427],"category_scores_gemma":[0.7521966,0.002127937,0.009342323,0.00851865,0.00722751,0.00647398,0.002892073,0.01362827,0.002617408],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.003497994,"about_ca_system_score_gemma":0.01109263,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0008024945,"about_ca_topic_score_gemma":0.001202664,"domain_scores_codex":[0.2540111,0.6734051,0.03680398,0.004485399,0.03051324,0.0007811661],"domain_scores_gemma":[0.107925,0.8362222,0.01857748,0.02126689,0.01516784,0.0008406498],"domain_codex":"methods","domain_gemma":"methods","domain_candidate":"methods","domain_consensus":"methods","study_design_codex":"design_other","study_design_gemma":"theoretical_or_conceptual","study_design_scores_codex":[0.01249742,0.0006179351,0.003447039,0.1056128,0.012407,0.001182963,0.002614184,0.01154261,0.002025183,0.2018306,0.05984881,0.5863734],"study_design_scores_gemma":[0.01103797,0.005900471,0.007406481,0.06476521,0.00737565,0.002184399,0.001076004,0.05238794,0.004655323,0.523979,0.3186768,0.0005548105],"study_design_candidate":"theoretical_or_conceptual","study_design_consensus":null,"genre_codex":"methods","genre_gemma":"review","genre_scores_codex":[0.003745157,0.09543557,0.8052083,0.03268659,0.01188969,0.03448206,0.001826963,0.001195107,0.01353062],"genre_scores_gemma":[0.0644194,0.0190742,0.8232755,0.01316053,0.004561781,0.07212383,0.0008102376,0.0004269465,0.002147536],"genre_candidate":"review","genre_consensus":null,"teacher_disagreement_score":0.4469694,"threshold_uncertainty_score":0.5511929,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.9821581373665009,"score_gpt":0.749156292279861,"score_spread":0.2330018450866399,"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."}}