{"id":"W3204361907","doi":"10.1016/j.biologicals.2021.09.002","title":"Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain","year":2021,"lang":"en","type":"article","venue":"Biologicals","topic":"Viral gastroenteritis research and epidemiology","field":"Medicine","cited_by":8,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada","funders":"Medical Research Council; Wellcome Trust","keywords":"Documentation; Quality (philosophy); Good manufacturing practice; Process (computing); Product (mathematics); Risk analysis (engineering); Control (management); Process management; Computer science; Quality by Design; New product development; Manufacturing process; Manufacturing engineering; Business; Operations management; Engineering; Marketing","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":[0.1666681,0.00356573,0.003346975,0.004987373,0.002512458,0.007093828,0.008731049,0.01931411,0.02215459],"category_scores_gemma":[0.1050774,0.003015819,0.004274992,0.003641685,0.007694748,0.006843457,0.005004523,0.009461286,0.02237613],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00347219,"about_ca_system_score_gemma":0.03124062,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.006207893,"about_ca_topic_score_gemma":0.01098029,"domain_scores_codex":[0.8910074,0.07456548,0.00892481,0.00306029,0.01973508,0.002706955],"domain_scores_gemma":[0.8878903,0.05195164,0.01067594,0.02317994,0.02155658,0.00474569],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"theoretical_or_conceptual","study_design_scores_codex":[0.002057765,0.003172183,0.002782571,0.01297109,0.0002073487,0.001404782,0.002537248,0.003041616,0.02864099,0.09147806,0.4101848,0.4415214],"study_design_scores_gemma":[0.0009153587,0.003806111,0.003024157,0.006771669,0.0001888254,0.0007899136,0.0007737874,0.001025548,0.01188349,0.02549451,0.9450474,0.0002790901],"study_design_candidate":"theoretical_or_conceptual","study_design_consensus":null,"genre_codex":"methods","genre_gemma":"methods","genre_scores_codex":[0.006130971,0.03710698,0.6266496,0.09747487,0.0100774,0.09407891,0.01141836,0.005261345,0.1118016],"genre_scores_gemma":[0.00923715,0.02523746,0.8391462,0.02292813,0.001713785,0.05481593,0.005405074,0.0008412867,0.04067507],"genre_candidate":"methods","genre_consensus":"methods","teacher_disagreement_score":0.1666681,"threshold_uncertainty_score":0.8814359,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.2536574262357846,"score_gpt":0.4428838146075007,"score_spread":0.1892263883717161,"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."}}