{"id":"W3138344390","doi":"10.18433/jpps31491","title":"A Survey of the Regulatory Requirements for the Waiver of In Vivo Bioequivalence Studies of Generic Products in Certain Dosage Forms by Participating Regulators and Organisations of the International Pharmaceutical Regulators Programme","year":2021,"lang":"en","type":"article","venue":"Journal of Pharmacy & Pharmaceutical Sciences","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":6,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada","funders":"","keywords":"Bioequivalence; Dosage form; Medicine; Pharmacology; Waiver; Business; Risk analysis (engineering); Pharmacokinetics; Law; Political science","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":true,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":["sts"],"consensus_categories":[],"category_scores_codex":[0.00519415,0.0001450536,0.000432165,0.00009158282,0.0001291166,0.00001083782,0.0006941294,0.00006115081,0.00008869963],"category_scores_gemma":[0.002307008,0.00006994556,0.0001397382,0.001105734,0.00280427,0.0001594183,0.0003325202,0.0002927583,4.971948e-8],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00006251581,"about_ca_system_score_gemma":0.0003385787,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00005389467,"about_ca_topic_score_gemma":0.00004511569,"domain_scores_codex":[0.9972089,0.0007559069,0.001144255,0.000230387,0.000336877,0.0003237086],"domain_scores_gemma":[0.9971918,0.001273346,0.0007737302,0.0001663706,0.0005535212,0.00004119411],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"bench_or_experimental","study_design_gemma":"bench_or_experimental","study_design_scores_codex":[0.0001959216,0.0003245127,0.2788447,0.0001169961,0.000214353,5.987139e-7,0.0004997472,0.00003009909,0.7104218,0.0003309161,0.0002560474,0.008764311],"study_design_scores_gemma":[0.001485804,0.00009411203,0.07249483,0.0001567611,0.0001883564,0.00001330887,0.0007288876,0.001232909,0.921598,0.0002113239,0.001717774,0.00007791499],"study_design_candidate":"bench_or_experimental","study_design_consensus":"bench_or_experimental","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9851898,0.009046693,0.00002663184,0.004759239,0.0005368481,0.0003677179,0.00005716615,0.000001692116,0.00001421414],"genre_scores_gemma":[0.9985084,0.0008075705,0.0004431688,0.0001674182,0.00001893538,0.00000934423,5.144743e-7,0.000005736496,0.00003889501],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.2111762,"threshold_uncertainty_score":0.9999095,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.2529679550569277,"score_gpt":0.4478067879928861,"score_spread":0.1948388329359585,"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."}}