{"id":"W2890474078","doi":"10.1186/s40164-018-0114-9","title":"Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy","year":2018,"lang":"en","type":"article","venue":"Experimental Hematology and Oncology","topic":"Neutropenia and Cancer Infections","field":"Medicine","cited_by":13,"is_retracted":false,"has_abstract":true,"ca_institutions":"Hydro One (Canada); Apotex (Canada)","funders":"","keywords":"Biosimilar; Pegfilgrastim; Medicine; Breast cancer; Equivalence (formal languages); Oncology; Internal medicine; Pharmacology; Medical physics; Filgrastim; Cancer; Granulocyte colony-stimulating factor; Chemotherapy; Mathematics","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":[0.008245081,0.000891539,0.002732377,0.0004357778,0.0004440655,0.001019842,0.0007292705,0.001898944,0.005601384],"category_scores_gemma":[0.006631491,0.000418641,0.002164378,0.0004352601,0.0015013,0.0009000281,0.0005207222,0.002666567,0.0008968867],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0007925346,"about_ca_system_score_gemma":0.001218316,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0001731757,"about_ca_topic_score_gemma":0.0002351811,"domain_scores_codex":[0.9952586,0.002615951,0.000397703,0.00061327,0.0007358819,0.0003786652],"domain_scores_gemma":[0.995486,0.001505218,0.001084593,0.0005742466,0.0006153101,0.0007346695],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"randomized_trial","study_design_gemma":"randomized_trial","study_design_scores_codex":[0.931174,0.03461525,0.002380378,0.0003704627,0.0007589158,0.00008273782,0.0001679503,0.0004768555,0.01075702,0.0004156002,0.0005369682,0.01826386],"study_design_scores_gemma":[0.2062892,0.7790297,0.006647805,0.00003534951,0.0005851215,0.00008901329,0.00005637357,0.00120694,0.003231733,0.0003445451,0.002452423,0.00003175692],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9859232,0.0008212566,0.001610584,0.0001868867,0.0003099043,0.009468161,0.0003792948,0.00003305087,0.001267593],"genre_scores_gemma":[0.9886043,0.000369303,0.002830333,0.0004051431,0.0001926745,0.006239649,0.0003612563,0.00001285804,0.0009843978],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.008245081,"threshold_uncertainty_score":0.04360467,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.05775297218359463,"score_gpt":0.4161463259655735,"score_spread":0.3583933537819789,"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."}}