{"id":"W2523109620","doi":"10.1177/009286150203600217","title":"Comparison of Additional Regulatory Requirements for Conducting Clinical Trials on Genetically-Modified Microorganisms and Recombinant DNA in Europe, the United States, and Canada","year":2002,"lang":"en","type":"article","venue":"Drug Information Journal","topic":"Cancer Research and Treatments","field":"Biochemistry, Genetics and Molecular Biology","cited_by":3,"is_retracted":false,"has_abstract":false,"ca_institutions":"","funders":"","keywords":"Biosafety; Genetically modified organism; Food and drug administration; Biotechnology; Advisory committee; Regulatory affairs; Genetically engineered; Clinical trial; Regulatory science; Recombinant DNA; Business; Medicine; Political science; Biology; Risk analysis (engineering); Gene; Genetics; Public administration; Bioinformatics","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":[],"consensus_categories":[],"category_scores_codex":[0.001041402,0.0000645925,0.0001508454,0.0000491881,0.0001088603,0.00003669212,0.0000613626,0.00003145791,0.00004739638],"category_scores_gemma":[0.000712393,0.00004522242,0.00002286226,0.00005438549,0.00006002421,0.00001391594,0.00002583772,0.0001063584,4.482685e-7],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00002556722,"about_ca_system_score_gemma":0.0001342987,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001733368,"about_ca_topic_score_gemma":0.004499182,"domain_scores_codex":[0.9988407,0.0002057164,0.0006250517,0.00006413679,0.0001465345,0.0001177935],"domain_scores_gemma":[0.9992089,0.0001610575,0.0003001744,0.00007163725,0.0001782612,0.0000799789],"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":[0.002766182,0.0005789838,0.02008178,0.0001421642,0.000700887,0.00000796334,0.001714365,0.001116946,0.01160821,0.0005022025,0.8412617,0.1195185],"study_design_scores_gemma":[0.03050976,0.003439417,0.0633503,0.0003868157,0.0001332812,0.0002259206,0.004445333,0.01865805,0.1304817,0.0004495711,0.7471709,0.0007489657],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9986607,0.0001462126,0.00007650844,0.000476145,0.00009687853,0.0002122758,0.0002523073,8.708793e-7,0.00007807765],"genre_scores_gemma":[0.998,0.0007097897,0.0001571449,0.0003498811,0.00005223752,0.000009777699,0.0006649303,0.00000454498,0.00005171094],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.1188735,"threshold_uncertainty_score":0.2620346,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1470181847862317,"score_gpt":0.395892182959248,"score_spread":0.2488739981730163,"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."}}