{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.005509985,0.001656386,0.002901574,0.002384606,0.0003835453,0.003060426,0.002707103,0.002641163,0.00255488],"category_scores_gemma":[0.003804418,0.0008432789,0.001282461,0.003426178,0.00185452,0.004401845,0.001849093,0.003931716,0.001508972],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.001271624,"about_ca_system_score_gemma":0.002049264,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00119454,"about_ca_topic_score_gemma":0.001451977,"domain_scores_codex":[0.9983371,0.000278394,0.0001912305,0.0002943401,0.0007659316,0.0001328835],"domain_scores_gemma":[0.9959583,0.002594457,0.0003593319,0.00016792,0.0007968162,0.0001232218],"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":[0.0001127962,0.0001649573,0.0001660431,0.02620159,0.0001449644,0.0001482324,0.0001193661,0.001374034,0.009649035,0.02358709,0.01312021,0.9252117],"study_design_scores_gemma":[0.00003726647,0.0004417035,0.0006369815,0.00651299,0.0002469961,0.0009625864,0.0001370845,0.001263634,0.007758975,0.01217959,0.969738,0.00008423139],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.0001910539,0.9967818,0.001870838,0.0003321776,0.00020679,0.0000087042,0.00001546217,0.00001264043,0.0005805026],"genre_scores_gemma":[0.001756476,0.9946622,0.002426546,0.000381563,0.0002580449,0.00001604172,0.00004058522,0.000007389032,0.0004512176],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.005509985,"threshold_uncertainty_score":0.02913994,"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."}}