{"id":"W3158746796","doi":"10.1002/0471266949.bmc276","title":"Clinical Development – A Primer","year":2021,"lang":"en","type":"other","venue":"Burger's Medicinal Chemistry and Drug Discovery","topic":"Statistical Methods in Clinical Trials","field":"Mathematics","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Clinical trial; Biosimilar; Regulatory science; Drug development; Medicine; New product development; Product (mathematics); Business; Agency (philosophy); Quality (philosophy); Process management; Drug; Pharmacology; Marketing; Pathology","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":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.02252952,0.00163863,0.0009370266,0.003883831,0.001985215,0.01113766,0.003569903,0.009553888,0.02038535],"category_scores_gemma":[0.03050593,0.00102041,0.001188055,0.003549642,0.01024605,0.01652038,0.008071717,0.01818012,0.02053413],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.004505548,"about_ca_system_score_gemma":0.007037143,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0009900088,"about_ca_topic_score_gemma":0.0009141981,"domain_scores_codex":[0.9796391,0.01202603,0.002037746,0.001807885,0.0038307,0.0006586572],"domain_scores_gemma":[0.9613996,0.02719213,0.001680705,0.001948656,0.005477236,0.002301721],"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":[0.00008582725,0.0002243981,0.0003352153,0.001577528,0.00001563749,0.0004931566,0.001251351,0.0005367167,0.0006173165,0.3438045,0.383948,0.2671103],"study_design_scores_gemma":[0.000008249216,0.00004374848,0.0000810402,0.001287898,0.000001906615,0.0004687106,0.0001786267,0.00009501669,0.00006426086,0.01977683,0.9779857,0.000008056386],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"methods","genre_scores_codex":[0.0008503172,0.3395254,0.0701291,0.3550248,0.03581398,0.0008511578,0.0004688979,0.0008830625,0.1964533],"genre_scores_gemma":[0.02333478,0.3940729,0.0968333,0.3188657,0.05115471,0.002633484,0.001097676,0.001182952,0.1108245],"genre_candidate":"methods","genre_consensus":null,"teacher_disagreement_score":0.02252952,"threshold_uncertainty_score":0.119149,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.2737468116283632,"score_gpt":0.506332284310644,"score_spread":0.2325854726822809,"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."}}