{"id":"W2041515373","doi":"10.1002/jps.23810","title":"A Quality-by-Design Study for an Immediate-Release Tablet Platform: Examining the Relative Impact of Active Pharmaceutical Ingredient Properties, Processing Methods, and Excipient Variability on Drug Product Quality Attributes","year":2013,"lang":"en","type":"article","venue":"Journal of Pharmaceutical Sciences","topic":"Drug Solubulity and Delivery Systems","field":"Pharmacology, Toxicology and Pharmaceutics","cited_by":39,"is_retracted":false,"has_abstract":false,"ca_institutions":"Patheon (Canada)","funders":"","keywords":"Friability; Granulation; Particle size; Excipient; Active ingredient; Materials science; Filler (materials); Quality by Design; Dosage form; Dissolution testing; Flow properties; Composite material; Chromatography; Chemistry; Pharmacology; Medicine; Polymer; Ethyl cellulose","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":["metaresearch","metaepi_narrow"],"consensus_categories":[],"category_scores_codex":[0.0397062,0.0004717362,0.00101782,0.0001851737,0.001017726,0.0001965244,0.0008393389,0.000183395,0.0001433317],"category_scores_gemma":[0.004171595,0.0002659808,0.0002457763,0.0006814589,0.001935382,0.001768327,0.000199013,0.00159206,0.000004282174],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0003187161,"about_ca_system_score_gemma":0.0007241371,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0002656583,"about_ca_topic_score_gemma":0.000004996594,"domain_scores_codex":[0.9861297,0.009316645,0.001925525,0.0007420094,0.0009914857,0.0008946536],"domain_scores_gemma":[0.9883706,0.008038047,0.001481835,0.0002615828,0.001013547,0.0008343626],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"bench_or_experimental","study_design_scores_codex":[0.02106948,0.01877997,0.08461873,0.001168566,0.002708845,0.00001729805,0.06060573,0.009426285,0.36898,0.001043185,0.005663244,0.4259187],"study_design_scores_gemma":[0.03075884,0.03094273,0.1124975,0.0007917178,0.003410982,0.0002901022,0.06064055,0.2956801,0.4393059,0.01153031,0.01068841,0.003462829],"study_design_candidate":"bench_or_experimental","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9863635,0.001535697,0.006313751,0.001306482,0.0008374911,0.00336312,0.0001023244,0.0000320718,0.0001455881],"genre_scores_gemma":[0.9967735,0.000109615,0.002044433,0.0004528898,0.0003963661,0.0001596171,0.000003464789,0.00002012344,0.00003998334],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.4224559,"threshold_uncertainty_score":0.9999793,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.4539464778161986,"score_gpt":0.5506357945623821,"score_spread":0.09668931674618353,"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."}}