{"id":"W1987479544","doi":"10.1016/j.biologicals.2011.06.003","title":"The first subsequent entry biologic authorized for market in Canada: The story of Omnitrope, a recombinant human growth hormone","year":2011,"lang":"en","type":"review","venue":"Biologicals","topic":"Biomedical Ethics and Regulation","field":"Medicine","cited_by":7,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada","funders":"","keywords":"Human growth hormone; Guideline; Growth hormone; Product (mathematics); Business; Marketing; Political science; Medicine; Law; Hormone","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.003405839,0.0003326226,0.001536882,0.00007109722,0.0003211648,0.000008072359,0.0004697647,0.0007592671,0.00006638074],"category_scores_gemma":[0.0008882748,0.00011463,0.0004061904,0.0002813542,0.0009541643,0.000008340316,0.0001318067,0.0008981447,0.000002012279],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0004472891,"about_ca_system_score_gemma":0.001320428,"about_ca_topic_candidate":true,"about_ca_topic_consensus":true,"about_ca_topic_score_codex":0.03501562,"about_ca_topic_score_gemma":0.04771745,"domain_scores_codex":[0.9972422,0.0007916195,0.0009643665,0.0003926482,0.000192332,0.0004168334],"domain_scores_gemma":[0.9967933,0.001850014,0.0006741914,0.0004301854,0.000142078,0.0001102078],"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":[0.0004533119,0.0003412621,0.0001602331,0.007378581,0.0005422028,0.00002959826,0.00005501517,1.573655e-8,0.00003961367,0.03002495,0.0382782,0.922697],"study_design_scores_gemma":[0.0005684506,0.0005538847,0.004568117,0.002016704,0.0002535199,0.00001399204,0.00003396457,0.000002811773,0.000001430804,0.002171053,0.9896428,0.0001732754],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.0001988555,0.993498,0.000008367071,0.002869303,0.0004452201,0.002412156,0.00007755483,0.00001524909,0.0004753266],"genre_scores_gemma":[0.004851178,0.9935787,0.00004730704,0.0001648293,0.0001411205,0.0004634594,0.0001757977,0.00001858338,0.000559003],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.9513646,"threshold_uncertainty_score":0.9714103,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1075299307319355,"score_gpt":0.3291406860213014,"score_spread":0.2216107552893659,"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."}}