{"id":"https://openalex.org/W3010713619","doi":"https://doi.org/10.1007/s13318-020-00613-9","title":"An Open-Label, Randomized, Single-Dose, Crossover, Comparative Pharmacokinetics Study of YLB113 and the Etanercept Reference Product in Healthy Adult Male Subjects","display_name":"An Open-Label, Randomized, Single-Dose, Crossover, Comparative Pharmacokinetics Study of YLB113 and the Etanercept Reference Product in Healthy Adult Male Subjects","publication_year":2020,"publication_date":"2020-03-14","ids":{"openalex":"https://openalex.org/W3010713619","doi":"https://doi.org/10.1007/s13318-020-00613-9","mag":"3010713619","pmid":"https://pubmed.ncbi.nlm.nih.gov/32172488","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/7359121"},"language":"en","primary_location":{"id":"doi:10.1007/s13318-020-00613-9","doi":"https://doi.org/10.1007/s13318-020-00613-9","is_oa":true,"landing_page_url":"https://doi.org/10.1007/s13318-020-00613-9","pdf_url":"https://link.springer.com/content/pdf/10.1007/s13318-020-00613-9.pdf","source":{"id":"https://openalex.org/S204244929","display_name":"European Journal of Drug Metabolism and Pharmacokinetics","issn_l":"0378-7966","issn":["0378-7966","2107-0180"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-b","doyens","jufo-1","medline","norway-1","poland-40","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310320330","host_organization_name":"Adis, Springer Healthcare","host_organization_lineage":["https://openalex.org/P4310320330","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Adis, Springer Healthcare","Springer Nature"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"European Journal of Drug Metabolism and Pharmacokinetics","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://link.springer.com/content/pdf/10.1007/s13318-020-00613-9.pdf","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5017799693","display_name":"Mustafa M. Shennak","orcid":"https://orcid.org/0000-0002-3508-9522","observed_orcids":["https://orcid.org/0000-0002-3508-9522"]},"institutions":[],"countries":[],"is_corresponding":true,"raw_author_name":"Mustafa Shennak","raw_affiliation_strings":["Triumpharma, 07 Yaroot St, Opposite Jubaiya Circle, Amman, 00962, Jordan. PI@triumpharma.com","Triumpharma, 07 Yaroot St, Opposite Jubaiya Circle, Amman, 00962, Jordan"],"raw_orcid":"https://orcid.org/0000-0002-3508-9522","affiliations":[{"raw_affiliation_string":"Triumpharma, 07 Yaroot St, Opposite Jubaiya Circle, Amman, 00962, Jordan. PI@triumpharma.com","institution_ids":[]},{"raw_affiliation_string":"Triumpharma, 07 Yaroot St, Opposite Jubaiya Circle, Amman, 00962, Jordan","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5031031562","display_name":"Rana Al-Jaouni","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Rana Al-Jaouni","raw_affiliation_strings":["Triumpharma, 07 Yaroot St, Opposite Jubaiya Circle, Amman, 00962, Jordan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Triumpharma, 07 Yaroot St, Opposite Jubaiya Circle, Amman, 00962, Jordan","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5066468902","display_name":"Santhosh Kshirasagar","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I21675474","display_name":"Lupin Pharmaceuticals (India)","ror":"https://ror.org/04wdr7416","country_code":"IN","type":"company","lineage":["https://openalex.org/I21675474"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Santhosh Kshirasagar","raw_affiliation_strings":["Lupin Limited, Mumbai, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Lupin Limited, Mumbai, India","institution_ids":["https://openalex.org/I21675474"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5009726467","display_name":"Ravisekhar Kasibhatta","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I21675474","display_name":"Lupin Pharmaceuticals (India)","ror":"https://ror.org/04wdr7416","country_code":"IN","type":"company","lineage":["https://openalex.org/I21675474"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Ravi Sekhar Kasibhatta","raw_affiliation_strings":["Lupin Limited, Mumbai, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Lupin Limited, Mumbai, India","institution_ids":["https://openalex.org/I21675474"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5027752399","display_name":"Neelima Godse","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I21675474","display_name":"Lupin Pharmaceuticals (India)","ror":"https://ror.org/04wdr7416","country_code":"IN","type":"company","lineage":["https://openalex.org/I21675474"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Neelima Godse","raw_affiliation_strings":["Lupin Limited, Mumbai, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Lupin Limited, Mumbai, India","institution_ids":["https://openalex.org/I21675474"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5056278024","display_name":"Ahmad Al\u2010Ghazawi","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Ahmad Al-Ghazawi","raw_affiliation_strings":["Triumpharma, 07 Yaroot St, Opposite Jubaiya Circle, Amman, 00962, Jordan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Triumpharma, 07 Yaroot St, Opposite Jubaiya Circle, Amman, 00962, Jordan","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5036672598","display_name":"Praveen Vittala","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I21675474","display_name":"Lupin Pharmaceuticals (India)","ror":"https://ror.org/04wdr7416","country_code":"IN","type":"company","lineage":["https://openalex.org/I21675474"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Praveen Vittala","raw_affiliation_strings":["Lupin Limited, Mumbai, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Lupin Limited, Mumbai, India","institution_ids":["https://openalex.org/I21675474"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5027031788","display_name":"Dhananjay Bakhle","orcid":"https://orcid.org/0000-0001-8701-9561","observed_orcids":["https://orcid.org/0000-0001-8701-9561"]},"institutions":[{"id":"https://openalex.org/I21675474","display_name":"Lupin Pharmaceuticals (India)","ror":"https://ror.org/04wdr7416","country_code":"IN","type":"company","lineage":["https://openalex.org/I21675474"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Dhananjay Bakhle","raw_affiliation_strings":["Lupin Limited, Mumbai, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Lupin Limited, Mumbai, India","institution_ids":["https://openalex.org/I21675474"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5017799693"],"corresponding_institution_ids":[],"apc_list":{"value":3260,"currency":"USD","value_usd":3260},"apc_paid":{"value":3260,"currency":"USD","value_usd":3260},"fwci":0.5991,"has_fulltext":true,"cited_by_count":9,"citation_normalized_percentile":{"value":0.60737717,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":92,"max":96},"biblio":{"volume":"45","issue":"4","first_page":"467","last_page":"475"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":1.0,"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"}},"topics":[{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":1.0,"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"}},{"id":"https://openalex.org/T10200","display_name":"Rheumatoid Arthritis Research and Therapies","score":0.0,"subfield":{"id":"https://openalex.org/subfields/2745","display_name":"Rheumatology"},"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/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.0,"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"}}],"keywords":[{"id":"https://openalex.org/keywords/etanercept","display_name":"etanercept","score":0.9890000224113464},{"id":"https://openalex.org/keywords/biosimilars","display_name":"biosimilars","score":0.9049999713897705},{"id":"https://openalex.org/keywords/pharmacokinetics","display_name":"pharmacokinetics","score":0.8180000185966492},{"id":"https://openalex.org/keywords/bioequivalence","display_name":"bioequivalence","score":0.9559999704360962},{"id":"https://openalex.org/keywords/rheumatoid-arthritis","display_name":"rheumatoid arthritis","score":0.8880000114440918},{"id":"https://openalex.org/keywords/subcutaneous-administration","display_name":"subcutaneous administration","score":0.7549999952316284},{"id":"https://openalex.org/keywords/adverse-events","display_name":"adverse events","score":0.5149999856948853},{"id":"https://openalex.org/keywords/healthy-volunteers","display_name":"healthy volunteers","score":0.5979999899864197}],"concepts":[{"id":"https://openalex.org/C2777226972","wikidata":"https://www.wikidata.org/wiki/Q415343","display_name":"Etanercept","level":3,"score":0.8824871778488159},{"id":"https://openalex.org/C42404028","wikidata":"https://www.wikidata.org/wiki/Q864940","display_name":"Bioequivalence","level":3,"score":0.8666949272155762},{"id":"https://openalex.org/C112705442","wikidata":"https://www.wikidata.org/wiki/Q323936","display_name":"Pharmacokinetics","level":2,"score":0.8511221408843994},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.7915173768997192},{"id":"https://openalex.org/C87813604","wikidata":"https://www.wikidata.org/wiki/Q1242899","display_name":"Crossover study","level":4,"score":0.7236940860748291},{"id":"https://openalex.org/C2777575956","wikidata":"https://www.wikidata.org/wiki/Q187255","display_name":"Rheumatoid arthritis","level":2,"score":0.628840446472168},{"id":"https://openalex.org/C22979827","wikidata":"https://www.wikidata.org/wiki/Q5137311","display_name":"Cmax","level":3,"score":0.602537214756012},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.5646597743034363},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.5519862174987793},{"id":"https://openalex.org/C181389837","wikidata":"https://www.wikidata.org/wiki/Q461809","display_name":"Bioavailability","level":2,"score":0.5080351829528809},{"id":"https://openalex.org/C76318530","wikidata":"https://www.wikidata.org/wiki/Q16833590","display_name":"Area under the curve","level":2,"score":0.4705424904823303},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.42143601179122925},{"id":"https://openalex.org/C27081682","wikidata":"https://www.wikidata.org/wiki/Q269829","display_name":"Placebo","level":3,"score":0.2262507975101471},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.06109505891799927},{"id":"https://openalex.org/C204787440","wikidata":"https://www.wikidata.org/wiki/Q188504","display_name":"Alternative medicine","level":2,"score":0.0}],"mesh":[{"descriptor_ui":"D000068800","descriptor_name":"Etanercept","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":false},{"descriptor_ui":"D000068800","descriptor_name":"Etanercept","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D000068800","descriptor_name":"Etanercept","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":true},{"descriptor_ui":"D000079424","descriptor_name":"Tumor Necrosis Factor Inhibitors","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":false},{"descriptor_ui":"D000079424","descriptor_name":"Tumor Necrosis Factor Inhibitors","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D000079424","descriptor_name":"Tumor Necrosis Factor Inhibitors","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":true},{"descriptor_ui":"D000328","descriptor_name":"Adult","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D001682","descriptor_name":"Biological Availability","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007279","descriptor_name":"Injections, Subcutaneous","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007597","descriptor_name":"Jordan","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008297","descriptor_name":"Male","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008875","descriptor_name":"Middle Aged","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D013810","descriptor_name":"Therapeutic Equivalency","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016903","descriptor_name":"Drug Monitoring","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D018592","descriptor_name":"Cross-Over Studies","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D055815","descriptor_name":"Young Adult","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D059451","descriptor_name":"Biosimilar Pharmaceuticals","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":false},{"descriptor_ui":"D059451","descriptor_name":"Biosimilar Pharmaceuticals","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D059451","descriptor_name":"Biosimilar Pharmaceuticals","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":true},{"descriptor_ui":"D064368","descriptor_name":"Healthy Volunteers","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":3,"locations":[{"id":"doi:10.1007/s13318-020-00613-9","doi":"https://doi.org/10.1007/s13318-020-00613-9","is_oa":true,"landing_page_url":"https://doi.org/10.1007/s13318-020-00613-9","pdf_url":"https://link.springer.com/content/pdf/10.1007/s13318-020-00613-9.pdf","source":{"id":"https://openalex.org/S204244929","display_name":"European Journal of Drug Metabolism and Pharmacokinetics","issn_l":"0378-7966","issn":["0378-7966","2107-0180"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-b","doyens","jufo-1","medline","norway-1","poland-40","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310320330","host_organization_name":"Adis, Springer Healthcare","host_organization_lineage":["https://openalex.org/P4310320330","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Adis, Springer Healthcare","Springer Nature"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"European Journal of Drug Metabolism and Pharmacokinetics","raw_type":"journal-article"},{"id":"pmid:32172488","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/32172488","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":"European journal of drug metabolism and pharmacokinetics","raw_type":"Comparative Study"},{"id":"pmh:oai:pubmedcentral.nih.gov:7359121","doi":null,"is_oa":true,"landing_page_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC7359121/","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"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":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Eur J Drug Metab Pharmacokinet","raw_type":"Text"}],"best_oa_location":{"id":"doi:10.1007/s13318-020-00613-9","doi":"https://doi.org/10.1007/s13318-020-00613-9","is_oa":true,"landing_page_url":"https://doi.org/10.1007/s13318-020-00613-9","pdf_url":"https://link.springer.com/content/pdf/10.1007/s13318-020-00613-9.pdf","source":{"id":"https://openalex.org/S204244929","display_name":"European Journal of Drug Metabolism and Pharmacokinetics","issn_l":"0378-7966","issn":["0378-7966","2107-0180"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-b","doyens","jufo-1","medline","norway-1","poland-40","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310320330","host_organization_name":"Adis, Springer Healthcare","host_organization_lineage":["https://openalex.org/P4310320330","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Adis, Springer Healthcare","Springer Nature"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"European Journal of Drug Metabolism and Pharmacokinetics","raw_type":"journal-article"},"sustainable_development_goals":[{"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3","score":0.9907000064849854}],"study_designs":[{"display_name":"Clinical Trial","id":"https://openalex.org/study-designs/clinical-trial"}],"awards":[],"funders":[{"id":"https://openalex.org/F4320316473","display_name":"Mylan","ror":"https://ror.org/04nsw4151"}],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W3010713619.pdf","grobid_xml":"https://content.openalex.org/works/W3010713619.grobid-xml"},"referenced_works_count":10,"referenced_works":["https://openalex.org/W2000183493","https://openalex.org/W2022837481","https://openalex.org/W2039470011","https://openalex.org/W2078010735","https://openalex.org/W2296528535","https://openalex.org/W2314052274","https://openalex.org/W2540519971","https://openalex.org/W2618615673","https://openalex.org/W2770586957","https://openalex.org/W2899558355"],"related_works":["https://openalex.org/W2953033542","https://openalex.org/W2996682695","https://openalex.org/W2618615673","https://openalex.org/W3164186675","https://openalex.org/W2004375912","https://openalex.org/W4306648667","https://openalex.org/W4401015830","https://openalex.org/W1927365763","https://openalex.org/W2780872292","https://openalex.org/W2039334262"],"abstract_inverted_index":{"YLB113":[0,46,71,194,199,235,245,264,280],"is":[1,15],"being":[2],"developed":[3],"as":[4],"a":[5,66],"biosimilar":[6],"of":[7,20,45,70,85,143,189,234,244,254,279],"the":[8,18,40,48,76,89,119,127,135,144,157,165,187,196,201,232,237,255,266,276],"antitumor":[9],"necrosis":[10],"factor-alpha":[11],"antagonist":[12],"etanercept,":[13],"which":[14],"approved":[16],"for":[17,97,134,183,281],"treatment":[19,91],"moderate-to-severe":[21],"rheumatoid":[22],"arthritis":[23],"(RA)":[24],"and":[25,43,47,75,101,122,174,191,200,217,228,236,248,265],"other":[26],"chronic":[27],"immune-mediated":[28],"inflammatory":[29],"diseases.":[30],"An":[31],"open-label,":[32],"crossover,":[33],"pharmacokinetic":[34,98,146,247],"study":[35],"was":[36],"conducted":[37],"to":[38,64,164,178],"compare":[39],"relative":[41],"bioavailability":[42],"safety":[44,249],"etanercept":[49,77,184,202,238,256,267],"reference":[50],"product":[51],"(RP)":[52],"Enbrel":[53],"\u00ae":[54],".":[55],"Healthy":[56],"male":[57,261],"subjects":[58,111,116,124,209,230],"aged":[59],"18\u201350":[60],"years":[61],"were":[62,95,112,185,204,224],"randomized":[63],"receive":[65],"single":[67,242],"subcutaneous":[68],"dose":[69,243],"in":[72,79,258,283],"one":[73],"period":[74,84,121],"RP":[78,203,257,268],"another":[80],"period.":[81,129],"A":[82,241],"washout":[83],"28":[86],"days":[87],"separated":[88],"two":[90],"periods.":[92,108],"Blood":[93],"samples":[94],"collected":[96],"analysis":[99,142],"predose":[100],"until":[102],"480":[103],"h":[104],"postdose":[105],"during":[106],"both":[107],"Overall,":[109],"52":[110],"enrolled,":[113],"including":[114,214],"51":[115],"who":[117,125],"completed":[118,126],"first":[120],"43":[123],"second":[128],"The":[130],"90%":[131],"confidence":[132],"intervals":[133],"least":[136],"squares":[137],"means":[138],"derived":[139],"from":[140,162,176],"an":[141],"log-transformed":[145],"parameters":[147],"maximum":[148],"serum":[149,158],"concentration":[150,168],"(":[151],"C":[152],"max":[153],"),":[154],"area":[155],"under":[156],"concentration\u2013time":[159],"curve":[160],"(AUC)":[161],"0":[163,177],"last":[166],"measurable":[167],"(AUC":[169,180],"(0-":[170],"t":[171],")":[172,173,182],"AUC":[175],"infinity":[179],"(0-\u221e)":[181],"between":[186],"limits":[188],"80":[190],"125%.":[192],"Thus,":[193],"met":[195],"bioequivalence":[197],"criterion.":[198],"well":[205],"tolerated,":[206],"with":[207,252,285],"24":[208],"reporting":[210],"53":[211],"adverse":[212,222],"events,":[213],"42":[215],"mild":[216],"11":[218],"moderate":[219],"events.":[220],"Treatment-emergent":[221],"events":[223],"reported":[225],"by":[226],"14":[227],"16":[229],"following":[231],"administration":[233],"RP,":[239],"respectively.":[240],"exhibited":[246],"profiles":[250],"comparable":[251],"those":[253],"healthy":[259],"adult":[260],"subjects.":[262],"Therefore,":[263],"can":[269],"be":[270],"considered":[271],"bioequivalent.":[272],"These":[273],"findings":[274],"support":[275],"continued":[277],"development":[278],"use":[282],"patients":[284],"RA.":[286],"31/Clinical/2018.":[287]},"counts_by_year":[{"year":2024,"cited_by_count":2},{"year":2023,"cited_by_count":3},{"year":2022,"cited_by_count":2},{"year":2021,"cited_by_count":2}],"updated_date":"2026-11-10T11:39:43.021295","created_date":"2020-03-23T00:00:00"}