{"id":"W2510798008","doi":"10.1186/s12931-016-0413-9","title":"How to achieve safe, high-quality clinical studies with non-Medicinal Investigational Products? A practical guideline by using intra-bronchial carbon nanoparticles as case study","year":2016,"lang":"en","type":"review","venue":"Respiratory Research","topic":"Animal testing and alternatives","field":"Veterinary","cited_by":2,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"Newfoundland and Labrador","keywords":"Good manufacturing practice; Guideline; Quality (philosophy); Risk analysis (engineering); Medicine; Product (mathematics); Clinical trial; Quality assurance; Business; Computer science; Operations management; Regulatory affairs; Pathology; Engineering","routes":{"ca_aff":false,"ca_fund":true,"ca_venue":false,"about_ca":false,"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":[0.08249981,0.001428597,0.001778067,0.002326851,0.002389596,0.006909654,0.003406669,0.01217912,0.003185697],"category_scores_gemma":[0.06491859,0.000801729,0.002353653,0.001328705,0.006812663,0.006861039,0.004776136,0.006928388,0.004571366],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.001857142,"about_ca_system_score_gemma":0.01072729,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001226593,"about_ca_topic_score_gemma":0.002260306,"domain_scores_codex":[0.9376693,0.04239303,0.008108403,0.002585762,0.008319125,0.0009243864],"domain_scores_gemma":[0.9435484,0.02896099,0.005457358,0.008586129,0.01075865,0.002688379],"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":[0.00133567,0.00172889,0.01066959,0.02058303,0.0004879589,0.0316231,0.01394062,0.001994071,0.05005791,0.06746373,0.1218126,0.6783028],"study_design_scores_gemma":[0.0004778224,0.001879732,0.004521936,0.01471935,0.0005428171,0.04054692,0.006225821,0.001565904,0.02093787,0.06208422,0.8461552,0.0003423413],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"methods","genre_gemma":"methods","genre_scores_codex":[0.02106062,0.1660399,0.5040214,0.2366631,0.006726671,0.01172028,0.0006481496,0.00185547,0.05126439],"genre_scores_gemma":[0.06677403,0.05515864,0.8120156,0.04715437,0.002792797,0.008109363,0.0004807168,0.0003579887,0.00715657],"genre_candidate":"methods","genre_consensus":"methods","teacher_disagreement_score":0.08249981,"threshold_uncertainty_score":0.4363059,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.8153669781730366,"score_gpt":0.6728364754310237,"score_spread":0.142530502742013,"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."}}