{"id":"W4283366803","doi":"10.1016/j.jpba.2022.114911","title":"A state of the art in analytical quality-by-design and perspectives in characterization of nano-enabled medicinal products","year":2022,"lang":"en","type":"review","venue":"Journal of Pharmaceutical and Biomedical Analysis","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":37,"is_retracted":false,"has_abstract":false,"ca_institutions":"Trinity College","funders":"Horizon 2020; Horizon 2020 Framework Programme; European Commission","keywords":"Quality by Design; Terminology; Robustness (evolution); Computer science; Quality (philosophy); Protocol (science); Risk analysis (engineering); Management science; Characterization (materials science); Biochemical engineering; Nanotechnology; Chemistry; Engineering","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":"codex-gemma-dda1882f352a","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.004490904,0.00027806,0.002671893,0.0009081459,0.00004591439,0.000009848188,0.0003256226,0.0002884614,0.0006454118],"category_scores_gemma":[0.0008848656,0.0001461119,0.0004922923,0.002905237,0.001302195,0.00005624337,0.0002040803,0.001178717,4.662598e-7],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00007671296,"about_ca_system_score_gemma":0.0002572814,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0000126693,"about_ca_topic_score_gemma":0.000002177995,"domain_scores_codex":[0.9941861,0.002878216,0.001983172,0.0003579123,0.0002997521,0.0002948643],"domain_scores_gemma":[0.9975088,0.001078393,0.001029109,0.0001590562,0.0001192831,0.0001053589],"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":[0.0008693196,0.002527327,0.0007637044,0.006045377,0.007529023,0.00005999871,0.0005433708,9.400345e-7,0.03042235,0.0002321054,0.0004118595,0.9505946],"study_design_scores_gemma":[0.002734448,0.0008882998,0.002166005,0.002458645,0.0154612,0.0002341512,0.0002942299,0.0002778516,0.001528748,0.0002302413,0.9732387,0.0004874636],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.005107482,0.9906596,0.0006872321,0.002865552,0.0001583873,0.0003646387,0.0001377237,0.000002659107,0.00001674292],"genre_scores_gemma":[0.007317977,0.9921073,0.0001803783,0.00008315461,0.00003209711,0.000005684351,0.00003043338,0.000009866115,0.0002330874],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.9728268,"threshold_uncertainty_score":0.7066807,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1205722383113485,"score_gpt":0.4076091022185198,"score_spread":0.2870368639071713,"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."}}