{"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":"codex-gemma-dda1882f352a","candidate_categories":["metaresearch","metaepi_narrow","insufficient_payload"],"consensus_categories":[],"category_scores_codex":[0.002977677,0.0005415409,0.001773751,0.00003284144,0.00006346692,0.00006106604,0.0002964776,0.0007333739,0.007726118],"category_scores_gemma":[0.03048627,0.0004390645,0.0002805511,0.0001289953,0.0005513884,0.00002956249,0.0003121812,0.0009011269,0.00001583441],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00004382549,"about_ca_system_score_gemma":0.0005655286,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00001744905,"about_ca_topic_score_gemma":0.000003774423,"domain_scores_codex":[0.995934,0.0003991349,0.001526415,0.0009862914,0.0007112439,0.0004429142],"domain_scores_gemma":[0.982136,0.01596799,0.0006885873,0.0007148027,0.00005507593,0.0004375551],"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":[0.0001123934,0.0005194186,0.001069843,0.003886741,0.0007407436,0.0004235692,0.00006424779,1.35207e-8,0.0001459695,0.001143824,0.9664085,0.02548474],"study_design_scores_gemma":[0.001740704,0.00002942874,0.0001933362,0.006928519,0.0006475187,0.00006547733,0.0002253287,0.000004035346,0.002908582,0.05505076,0.9310778,0.001128541],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"other","genre_scores_codex":[0.003162241,0.01112694,0.02357909,0.0006399952,0.00382078,0.0008231223,0.0002045236,0.0003716782,0.9562716],"genre_scores_gemma":[0.00023806,0.0009618205,0.2272818,0.0003809897,0.004028519,0.00005966826,0.0000628796,0.0003655898,0.7666207],"genre_candidate":"other","genre_consensus":"other","teacher_disagreement_score":0.2037027,"threshold_uncertainty_score":0.9998061,"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."}}