{"id":"W6967809012","doi":"10.5281/zenodo.1079863","title":"Generic Drug In Global Market And Regulatory Environment","year":2017,"lang":"en","type":"article","venue":"Zenodo (CERN European Organization for Nuclear Research)","topic":"Pharmaceutical Quality and Counterfeiting","field":"Medicine","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Generic drug; Regulatory agency; Harmonization; Drug development; Agency (philosophy); Regulatory affairs; Pharmaceutical industry; Good manufacturing practice; Drug; Regulatory science","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":[0.003920678,0.0004759212,0.0006078482,0.002326737,0.001109729,0.00718059,0.0007979619,0.003299403,0.05015191],"category_scores_gemma":[0.006526214,0.0001894286,0.0004693067,0.003371632,0.002871397,0.005470527,0.002383454,0.002947517,0.02385691],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.002640854,"about_ca_system_score_gemma":0.004476205,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001371242,"about_ca_topic_score_gemma":0.0008783499,"domain_scores_codex":[0.9955813,0.0009587536,0.0002874344,0.0007907986,0.001993062,0.0003885969],"domain_scores_gemma":[0.9961045,0.0007244094,0.0006240387,0.0005205483,0.001567043,0.0004595186],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"theoretical_or_conceptual","study_design_gemma":"not_applicable","study_design_scores_codex":[0.00008172897,0.0000661867,0.001259493,0.001105634,0.00002185584,0.000495002,0.0004688133,0.0002983647,0.002587484,0.3659775,0.2721582,0.3554797],"study_design_scores_gemma":[0.000005024592,0.00002598056,0.0007551659,0.0001519999,0.00000491588,0.0004159258,0.00008082874,0.00004271269,0.0002600484,0.006626719,0.9916238,0.000006885207],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"other","genre_gemma":"empirical","genre_scores_codex":[0.005846782,0.0703316,0.008358508,0.04287487,0.003179683,0.000276727,0.002538465,0.001306477,0.8652868],"genre_scores_gemma":[0.2459828,0.1327651,0.03167851,0.05927509,0.00905976,0.0006544852,0.005731971,0.001026447,0.5138258],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.05015191,"threshold_uncertainty_score":0.1677749,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.06007239745947099,"score_gpt":0.305635021432849,"score_spread":0.245562623973378,"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."}}