{"id":"https://openalex.org/W2740930730","doi":null,"title":"E17 : \u56fd\u969b\u5171\u540c\u6cbb\u9a13 General Principles on Planning/Designing Multi-Regional Clinical Trials (\u7814\u4fee\u4f1a\u30d7\u30ed\u30b7\u30a3\u30fc\u30c7\u30a3\u30f3\u30b0 ICH\u65e5\u672c\u30b7\u30f3\u30dd\u30b8\u30a6\u30e02015(\u7b2c32\u56deICH\u5373\u6642\u5831\u544a\u4f1a)\u3088\u308a) -- (\u6709\u52b9\u6027\u306b\u95a2\u3059\u308b\u30c8\u30d4\u30c3\u30af\u306e\u52d5\u5411)","display_name":"E17 : \u56fd\u969b\u5171\u540c\u6cbb\u9a13 General Principles on Planning/Designing Multi-Regional Clinical Trials (\u7814\u4fee\u4f1a\u30d7\u30ed\u30b7\u30a3\u30fc\u30c7\u30a3\u30f3\u30b0 ICH\u65e5\u672c\u30b7\u30f3\u30dd\u30b8\u30a6\u30e02015(\u7b2c32\u56deICH\u5373\u6642\u5831\u544a\u4f1a)\u3088\u308a) -- (\u6709\u52b9\u6027\u306b\u95a2\u3059\u308b\u30c8\u30d4\u30c3\u30af\u306e\u52d5\u5411)","publication_year":2016,"publication_date":"2016-01-01","ids":{"openalex":"https://openalex.org/W2740930730","mag":"2740930730"},"language":"ja","primary_location":{"id":"mag:2740930730","doi":null,"is_oa":false,"landing_page_url":"http://ci.nii.ac.jp/naid/40020883024","pdf_url":null,"source":{"id":"https://openalex.org/S4306544871","display_name":"\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30b5\u30a4\u30a8\u30f3\u30b9","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":null,"license_id":null,"version":null,"is_accepted":false,"is_published":false,"raw_source_name":"\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30b5\u30a4\u30a8\u30f3\u30b9 = Pharmaceutical and medical device regulatory science","raw_type":null},"volume":null,"type":"conference-abstract","is_traditional":false,"indexed_in":[],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5032335603","display_name":"\u9752\u4e95\u967d\u5b50","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":true,"raw_author_name":"\u967d\u5b50 \u9752\u4e95","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":["https://openalex.org/A5032335603"],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":null,"has_fulltext":false,"cited_by_count":8,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":"47","issue":"6","first_page":"454","last_page":"456"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.9980000257492065,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},"topics":[{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.9980000257492065,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T12547","display_name":"Pharmaceutical studies and practices","score":0.000699999975040555,"subfield":{"id":"https://openalex.org/subfields/2735","display_name":"Pediatrics, Perinatology and Child Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10582","display_name":"Ethics in Clinical Research","score":9.999999747378752e-05,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/multiregional-clinical-trials","display_name":"multiregional clinical trials","score":0.9190000295639038},{"id":"https://openalex.org/keywords/regulatory-guidance","display_name":"regulatory guidelines","score":0.5740000009536743}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.4434528350830078},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.43548157811164856},{"id":"https://openalex.org/C177713679","wikidata":"https://www.wikidata.org/wiki/Q679690","display_name":"Intensive care medicine","level":1,"score":0.33765852451324463},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.33250701427459717},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.12008997797966003}],"mesh":[],"locations_count":1,"locations":[{"id":"mag:2740930730","doi":null,"is_oa":false,"landing_page_url":"http://ci.nii.ac.jp/naid/40020883024","pdf_url":null,"source":{"id":"https://openalex.org/S4306544871","display_name":"\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30b5\u30a4\u30a8\u30f3\u30b9","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":null,"license_id":null,"version":null,"is_accepted":false,"is_published":false,"raw_source_name":"\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30b5\u30a4\u30a8\u30f3\u30b9 = Pharmaceutical and medical device regulatory science","raw_type":null}],"best_oa_location":null,"sustainable_development_goals":[{"score":0.8048999905586243,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W3083799359","https://openalex.org/W6903767436","https://openalex.org/W3108699938","https://openalex.org/W3084325802","https://openalex.org/W4406090268","https://openalex.org/W2888308032","https://openalex.org/W3212357747","https://openalex.org/W4300636203","https://openalex.org/W7099636953","https://openalex.org/W3088729453"],"abstract_inverted_index":null,"counts_by_year":[{"year":2021,"cited_by_count":1},{"year":2020,"cited_by_count":3},{"year":2019,"cited_by_count":1},{"year":2018,"cited_by_count":1},{"year":2017,"cited_by_count":2}],"updated_date":"2026-11-03T10:50:19.383937","created_date":"2017-08-08T00:00:00"}
