{"id":"https://openalex.org/W20023912","doi":null,"title":"Sample size determination: extended tables for the multiplicative model and bioequivalence ranges of 0.9 to 1.11 and 0.7 to 1.43.","display_name":"Sample size determination: extended tables for the multiplicative model and bioequivalence ranges of 0.9 to 1.11 and 0.7 to 1.43.","publication_year":1992,"publication_date":"1992-01-01","ids":{"openalex":"https://openalex.org/W20023912","mag":"20023912","pmid":"https://pubmed.ncbi.nlm.nih.gov/1526691"},"language":"en","primary_location":{"id":"pmid:1526691","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/1526691","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International journal of clinical pharmacology, therapy, and toxicology","raw_type":"Journal Article"},"volume":null,"type":"article","indexed_in":["pubmed"],"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/A5060777732","display_name":"Edgar Diletti","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"E Diletti","raw_affiliation_strings":["Department of Biometry, Byk Gulden Pharmaceuticals, Konstanz, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Biometry, Byk Gulden Pharmaceuticals, Konstanz, Germany","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5024998348","display_name":"Dieter Hauschke","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"D Hauschke","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"last","author":{"id":"https://openalex.org/A5111812745","display_name":"Volker W. Steinijans","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"V W Steinijans","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":2.498,"has_fulltext":false,"cited_by_count":34,"citation_normalized_percentile":{"value":0.88981824,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":96},"biblio":{"volume":"30","issue":"8","first_page":"287","last_page":"62"},"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":0.00039999998989515007,"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/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.00019999999494757503,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/sample-size-calculation","display_name":"sample size determination","score":0.9940000176429749},{"id":"https://openalex.org/keywords/bioequivalence","display_name":"bioequivalence","score":0.9290000200271606},{"id":"https://openalex.org/keywords/multiplicative-model","display_name":"multiplicative model","score":0.9810000061988831},{"id":"https://openalex.org/keywords/logarithmic-normal-distribution","display_name":"logarithmic normal distribution","score":0.9330000281333923},{"id":"https://openalex.org/keywords/two-one-sided-tests","display_name":"two one-sided tests","score":0.8479999899864197},{"id":"https://openalex.org/keywords/90-confidence-interval","display_name":"90% confidence interval","score":0.8289999961853027}],"concepts":[{"id":"https://openalex.org/C42747912","wikidata":"https://www.wikidata.org/wiki/Q1048447","display_name":"Multiplicative function","level":2,"score":0.7994087934494019},{"id":"https://openalex.org/C42404028","wikidata":"https://www.wikidata.org/wiki/Q864940","display_name":"Bioequivalence","level":3,"score":0.7566007375717163},{"id":"https://openalex.org/C2780069185","wikidata":"https://www.wikidata.org/wiki/Q7977945","display_name":"Equivalence (formal languages)","level":2,"score":0.7391911745071411},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.7362215518951416},{"id":"https://openalex.org/C105795698","wikidata":"https://www.wikidata.org/wiki/Q12483","display_name":"Statistics","level":1,"score":0.7127168774604797},{"id":"https://openalex.org/C129848803","wikidata":"https://www.wikidata.org/wiki/Q2564360","display_name":"Sample size determination","level":2,"score":0.6412858963012695},{"id":"https://openalex.org/C44249647","wikidata":"https://www.wikidata.org/wiki/Q208498","display_name":"Confidence interval","level":2,"score":0.5847251415252686},{"id":"https://openalex.org/C39927690","wikidata":"https://www.wikidata.org/wiki/Q11197","display_name":"Logarithm","level":2,"score":0.5680138468742371},{"id":"https://openalex.org/C204323151","wikidata":"https://www.wikidata.org/wiki/Q905424","display_name":"Range (aeronautics)","level":2,"score":0.4466113746166229},{"id":"https://openalex.org/C122507166","wikidata":"https://www.wikidata.org/wiki/Q628906","display_name":"Crossover","level":2,"score":0.41777315735816956},{"id":"https://openalex.org/C114614502","wikidata":"https://www.wikidata.org/wiki/Q76592","display_name":"Combinatorics","level":1,"score":0.3967575132846832},{"id":"https://openalex.org/C28826006","wikidata":"https://www.wikidata.org/wiki/Q33521","display_name":"Applied mathematics","level":1,"score":0.3295975923538208},{"id":"https://openalex.org/C118615104","wikidata":"https://www.wikidata.org/wiki/Q121416","display_name":"Discrete mathematics","level":1,"score":0.20715376734733582},{"id":"https://openalex.org/C134306372","wikidata":"https://www.wikidata.org/wiki/Q7754","display_name":"Mathematical analysis","level":1,"score":0.14024534821510315},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.13783714175224304},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.0},{"id":"https://openalex.org/C181389837","wikidata":"https://www.wikidata.org/wiki/Q461809","display_name":"Bioavailability","level":2,"score":0.0},{"id":"https://openalex.org/C192562407","wikidata":"https://www.wikidata.org/wiki/Q228736","display_name":"Materials science","level":0,"score":0.0},{"id":"https://openalex.org/C60644358","wikidata":"https://www.wikidata.org/wiki/Q128570","display_name":"Bioinformatics","level":1,"score":0.0},{"id":"https://openalex.org/C159985019","wikidata":"https://www.wikidata.org/wiki/Q181790","display_name":"Composite material","level":1,"score":0.0},{"id":"https://openalex.org/C154945302","wikidata":"https://www.wikidata.org/wiki/Q11660","display_name":"Artificial intelligence","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D013223","descriptor_name":"Statistics as Topic","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D013810","descriptor_name":"Therapeutic Equivalency","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D016001","descriptor_name":"Confidence Intervals","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":3,"locations":[{"id":"pmid:1526691","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/1526691","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International journal of clinical pharmacology, therapy, and toxicology","raw_type":"Journal Article"},{"id":"pmid:1601533","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/1601533","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International journal of clinical pharmacology, therapy, and toxicology","raw_type":"Comparative Study"},{"id":"mag:20023912","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/1526691","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":null,"is_accepted":false,"is_published":false,"raw_source_name":"PubMed","raw_type":null}],"best_oa_location":null,"sustainable_development_goals":[{"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3","score":0.5683000087738037}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":92,"referenced_works":["https://openalex.org/W2048168597","https://openalex.org/W1974693247","https://openalex.org/W1986406178","https://openalex.org/W2128972757","https://openalex.org/W2001976945","https://openalex.org/W2099362727","https://openalex.org/W2078034063","https://openalex.org/W2101164896","https://openalex.org/W2142597103","https://openalex.org/W2043610941","https://openalex.org/W2096847256","https://openalex.org/W1979266847","https://openalex.org/W2014588550","https://openalex.org/W2079280892","https://openalex.org/W2001283671","https://openalex.org/W1976894414","https://openalex.org/W1995263077","https://openalex.org/W1973502328","https://openalex.org/W2123488363","https://openalex.org/W2039677826","https://openalex.org/W2011493215","https://openalex.org/W2024169780","https://openalex.org/W1989918489","https://openalex.org/W2105825085","https://openalex.org/W2126826272","https://openalex.org/W2109968053","https://openalex.org/W1977767796","https://openalex.org/W2082628274","https://openalex.org/W2002296044","https://openalex.org/W2093550697","https://openalex.org/W2064660141","https://openalex.org/W1977379905","https://openalex.org/W2056089554","https://openalex.org/W1991052198","https://openalex.org/W2088291698","https://openalex.org/W2078317560","https://openalex.org/W2073707228","https://openalex.org/W2091344322","https://openalex.org/W2031278133","https://openalex.org/W2151692510","https://openalex.org/W2123535919","https://openalex.org/W1970455124","https://openalex.org/W2055032753","https://openalex.org/W2009891872","https://openalex.org/W2130683000","https://openalex.org/W2156251634","https://openalex.org/W2117364665","https://openalex.org/W2070621112","https://openalex.org/W2045961146","https://openalex.org/W1974755779","https://openalex.org/W2057184364","https://openalex.org/W2062668093","https://openalex.org/W2050964244","https://openalex.org/W2039116649","https://openalex.org/W1979621373","https://openalex.org/W2085850546","https://openalex.org/W2014332131","https://openalex.org/W2129585241","https://openalex.org/W2047204570","https://openalex.org/W2091413056","https://openalex.org/W2066848717","https://openalex.org/W2078583470","https://openalex.org/W2155335795","https://openalex.org/W2012906058","https://openalex.org/W2037944484","https://openalex.org/W2062328767","https://openalex.org/W2127479635","https://openalex.org/W2321972685","https://openalex.org/W2036777770","https://openalex.org/W2097447766","https://openalex.org/W2011514854","https://openalex.org/W1516114521","https://openalex.org/W1983060592","https://openalex.org/W2011452209","https://openalex.org/W2103845650","https://openalex.org/W2040184556","https://openalex.org/W2041919246","https://openalex.org/W2065485865","https://openalex.org/W1966441186","https://openalex.org/W2074868180","https://openalex.org/W3021815292","https://openalex.org/W2165810890","https://openalex.org/W2055263756","https://openalex.org/W2055185930","https://openalex.org/W2104443668","https://openalex.org/W1993153142","https://openalex.org/W2100402476","https://openalex.org/W2038692006","https://openalex.org/W2129213133","https://openalex.org/W2095395178","https://openalex.org/W2163412070","https://openalex.org/W2002313830"],"related_works":["https://openalex.org/W2111073558","https://openalex.org/W2032922280","https://openalex.org/W75324476","https://openalex.org/W2350809711","https://openalex.org/W2405855529","https://openalex.org/W2498912752","https://openalex.org/W3043892388","https://openalex.org/W2127418645","https://openalex.org/W2573692496","https://openalex.org/W2739549576"],"abstract_inverted_index":{"For":[0],"the":[1,12,20,23,28,38,47,56,59,80,92],"two-period":[2],"crossover":[3],"design":[4],"and":[5,35],"a":[6],"multiplicative":[7],"model":[8],"(logarithmic":[9],"normal":[10],"distribution)":[11],"decision":[13],"procedure":[14],"of":[15,22,30,58,73,84,95],"choice":[16],"is":[17,44],"based":[18,54],"on":[19,55],"inclusion":[21,42],"shortest":[24],"90%-confidence":[25],"interval":[26],"for":[27,33,69,79,91],"ratio":[29],"expected":[31],"medians":[32],"test":[34],"reference":[36],"in":[37,101],"equivalence":[39,71,82],"range.":[40],"This":[41],"rule":[43],"equivalent":[45],"to":[46,75,86,97],"two":[48],"one-sided":[49],"tests":[50],"procedure.":[51],"Sample":[52],"sizes":[53],"power":[57],"latter":[60],"have":[61],"been":[62],"given":[63,100],"by":[64],"Diletti":[65],"et":[66],"al.":[67],"[1991]":[68],"an":[70],"range":[72,83,94],"0.8":[74],"1.25.":[76],"Corresponding":[77],"tables":[78],"tighter":[81],"0.9":[85],"1.11":[87],"as":[88,90],"well":[89],"wider":[93],"0.7":[96],"1.43":[98],"are":[99],"this":[102],"amendment.":[103]},"counts_by_year":[{"year":2025,"cited_by_count":1},{"year":2022,"cited_by_count":1},{"year":2021,"cited_by_count":1},{"year":2015,"cited_by_count":2},{"year":2014,"cited_by_count":1},{"year":2013,"cited_by_count":2}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2016-06-24T00:00:00"}