{"id":"https://openalex.org/W2038900628","doi":"https://doi.org/10.2165/00003088-200544040-00001","title":"Pharmacokinetic and Pharmacodynamic Considerations in the Development of Therapeutic Proteins","display_name":"Pharmacokinetic and Pharmacodynamic Considerations in the Development of Therapeutic Proteins","publication_year":2005,"publication_date":"2005-01-01","ids":{"openalex":"https://openalex.org/W2038900628","doi":"https://doi.org/10.2165/00003088-200544040-00001","mag":"2038900628","pmid":"https://pubmed.ncbi.nlm.nih.gov/15828849"},"language":"en","primary_location":{"id":"doi:10.2165/00003088-200544040-00001","doi":"https://doi.org/10.2165/00003088-200544040-00001","is_oa":false,"landing_page_url":"https://doi.org/10.2165/00003088-200544040-00001","pdf_url":null,"source":{"id":"https://openalex.org/S69290020","display_name":"Clinical Pharmacokinetics","issn_l":"0312-5963","issn":["0312-5963","1179-1926"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-b","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","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":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Pharmacokinetics","raw_type":"journal-article"},"volume":null,"type":"review","is_traditional":true,"indexed_in":["crossref","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/A5037939650","display_name":"Iftekhar Mahmood","orcid":"https://orcid.org/0000-0003-1311-4237","observed_orcids":["https://orcid.org/0000-0003-1311-4237","https://orcid.org/0000-0002-8008-0981"]},"institutions":[{"id":"https://openalex.org/I1320320070","display_name":"United States Food and Drug Administration","ror":"https://ror.org/034xvzb47","country_code":"US","type":"government","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070"]},{"id":"https://openalex.org/I1333606569","display_name":"Center for Drug Evaluation and Research","ror":"https://ror.org/00yf3tm42","country_code":"US","type":"facility","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070","https://openalex.org/I1333606569"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Iftekhar Mahmood","raw_affiliation_strings":["Clinical Pharmacology and Toxicology Branch, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA. Mahmoodi@CDER.FDA.Gov","Clinical Pharmacology and Toxicology Branch, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, Food and Drug Administration, Woodmont Office Center II, Rockville, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Pharmacology and Toxicology Branch, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA. Mahmoodi@CDER.FDA.Gov","institution_ids":["https://openalex.org/I1320320070","https://openalex.org/I1333606569"]},{"raw_affiliation_string":"Clinical Pharmacology and Toxicology Branch, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, Food and Drug Administration, Woodmont Office Center II, Rockville, USA","institution_ids":["https://openalex.org/I1320320070","https://openalex.org/I1333606569"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5058306337","display_name":"Martin D Green","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1320320070","display_name":"United States Food and Drug Administration","ror":"https://ror.org/034xvzb47","country_code":"US","type":"government","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070"]},{"id":"https://openalex.org/I1333606569","display_name":"Center for Drug Evaluation and Research","ror":"https://ror.org/00yf3tm42","country_code":"US","type":"facility","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070","https://openalex.org/I1333606569"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Martin D Green","raw_affiliation_strings":["Clinical Pharmacology and Toxicology Branch, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, Food and Drug Administration, Woodmont Office Center II, 1451 Rockville Pike, Rockville, Maryland, 20852, USA","Clinical Pharmacology and Toxicology Branch, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, Food and Drug Administration, Woodmont Office Center II, Rockville, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Pharmacology and Toxicology Branch, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, Food and Drug Administration, Woodmont Office Center II, 1451 Rockville Pike, Rockville, Maryland, 20852, USA","institution_ids":["https://openalex.org/I1320320070","https://openalex.org/I1333606569"]},{"raw_affiliation_string":"Clinical Pharmacology and Toxicology Branch, Office of Drug Evaluation VI, Center for Drug Evaluation and Research, Food and Drug Administration, Woodmont Office Center II, Rockville, USA","institution_ids":["https://openalex.org/I1320320070","https://openalex.org/I1333606569"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":["https://openalex.org/A5037939650"],"corresponding_institution_ids":["https://openalex.org/I1320320070","https://openalex.org/I1333606569"],"apc_list":{"value":4990,"currency":"USD","value_usd":4990},"apc_paid":null,"fwci":0.5394,"has_fulltext":false,"cited_by_count":154,"citation_normalized_percentile":{"value":0.51610487,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":96,"max":99},"biblio":{"volume":"44","issue":"4","first_page":"331","last_page":"347"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.9146000146865845,"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":0.9146000146865845,"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/T11016","display_name":"Monoclonal and Polyclonal Antibodies Research","score":0.07349999994039536,"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/T11124","display_name":"Protein purification and stability","score":0.008100000210106373,"subfield":{"id":"https://openalex.org/subfields/1312","display_name":"Molecular Biology"},"field":{"id":"https://openalex.org/fields/13","display_name":"Biochemistry, Genetics and Molecular Biology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/therapeutic-proteins","display_name":"therapeutic proteins","score":0.9909999966621399},{"id":"https://openalex.org/keywords/pharmacokinetics","display_name":"pharmacokinetics","score":0.9369999766349792},{"id":"https://openalex.org/keywords/pharmacodynamics","display_name":"pharmacodynamics","score":0.9860000014305115},{"id":"https://openalex.org/keywords/bioanalytical-methods","display_name":"bioanalytical methods","score":0.8140000104904175},{"id":"https://openalex.org/keywords/immunoassay-interference","display_name":"immunoassay interference","score":0.7730000019073486},{"id":"https://openalex.org/keywords/protein-binding","display_name":"protein binding","score":0.47200000286102295},{"id":"https://openalex.org/keywords/metabolite-quantification","display_name":"metabolite quantification","score":0.6700000166893005},{"id":"https://openalex.org/keywords/species-specificity","display_name":"species specificity","score":0.7319999933242798},{"id":"https://openalex.org/keywords/antibody-production","display_name":"antibody production","score":0.7739999890327454},{"id":"https://openalex.org/keywords/immunogenicity","display_name":"immunogenicity","score":0.9580000042915344},{"id":"https://openalex.org/keywords/glycosylation","display_name":"glycosylation","score":0.9449999928474426},{"id":"https://openalex.org/keywords/pegylation","display_name":"PEGylation","score":0.9990000128746033},{"id":"https://openalex.org/keywords/protein-absorption","display_name":"protein absorption","score":0.5260000228881836},{"id":"https://openalex.org/keywords/drug-delivery","display_name":"drug delivery","score":0.44999998807907104},{"id":"https://openalex.org/keywords/preclinical-evaluation","display_name":"preclinical evaluation","score":0.550000011920929}],"concepts":[{"id":"https://openalex.org/C112705442","wikidata":"https://www.wikidata.org/wiki/Q323936","display_name":"Pharmacokinetics","level":2,"score":0.867835521697998},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.6909158229827881},{"id":"https://openalex.org/C2779149719","wikidata":"https://www.wikidata.org/wiki/Q682252","display_name":"PEGylation","level":3,"score":0.6686349511146545},{"id":"https://openalex.org/C137535248","wikidata":"https://www.wikidata.org/wiki/Q4914691","display_name":"Bioanalysis","level":2,"score":0.5471320748329163},{"id":"https://openalex.org/C2780868878","wikidata":"https://www.wikidata.org/wiki/Q1660197","display_name":"Immunogenicity","level":3,"score":0.46724748611450195},{"id":"https://openalex.org/C2780035454","wikidata":"https://www.wikidata.org/wiki/Q8386","display_name":"Drug","level":2,"score":0.45906949043273926},{"id":"https://openalex.org/C19831878","wikidata":"https://www.wikidata.org/wiki/Q659446","display_name":"Therapeutic index","level":3,"score":0.441747784614563},{"id":"https://openalex.org/C2781047461","wikidata":"https://www.wikidata.org/wiki/Q679692","display_name":"Biopharmaceutical","level":2,"score":0.43385520577430725},{"id":"https://openalex.org/C64903051","wikidata":"https://www.wikidata.org/wiki/Q2198549","display_name":"Drug development","level":3,"score":0.42504674196243286},{"id":"https://openalex.org/C185592680","wikidata":"https://www.wikidata.org/wiki/Q2329","display_name":"Chemistry","level":0,"score":0.42074739933013916},{"id":"https://openalex.org/C70721500","wikidata":"https://www.wikidata.org/wiki/Q177005","display_name":"Computational biology","level":1,"score":0.3495216965675354},{"id":"https://openalex.org/C207001950","wikidata":"https://www.wikidata.org/wiki/Q141124","display_name":"In vivo","level":2,"score":0.34394747018814087},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.3203628659248352},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.2617573142051697},{"id":"https://openalex.org/C159654299","wikidata":"https://www.wikidata.org/wiki/Q79460","display_name":"Antibody","level":2,"score":0.24094513058662415},{"id":"https://openalex.org/C203014093","wikidata":"https://www.wikidata.org/wiki/Q101929","display_name":"Immunology","level":1,"score":0.13869574666023254},{"id":"https://openalex.org/C43617362","wikidata":"https://www.wikidata.org/wiki/Q170050","display_name":"Chromatography","level":1,"score":0.07532283663749695},{"id":"https://openalex.org/C150903083","wikidata":"https://www.wikidata.org/wiki/Q7108","display_name":"Biotechnology","level":1,"score":0.07309818267822266}],"mesh":[{"descriptor_ui":"D000042","descriptor_name":"Absorption","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004353","descriptor_name":"Drug Evaluation, Preclinical","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006031","descriptor_name":"Glycosylation","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":"D007668","descriptor_name":"Kidney","qualifier_ui":"Q000378","qualifier_name":"metabolism","is_major_topic":false},{"descriptor_ui":"D008099","descriptor_name":"Liver","qualifier_ui":"Q000378","qualifier_name":"metabolism","is_major_topic":false},{"descriptor_ui":"D011092","descriptor_name":"Polyethylene Glycols","qualifier_ui":"Q000737","qualifier_name":"chemistry","is_major_topic":false},{"descriptor_ui":"D011506","descriptor_name":"Proteins","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":false},{"descriptor_ui":"D011506","descriptor_name":"Proteins","qualifier_ui":"Q000494","qualifier_name":"pharmacology","is_major_topic":true},{"descriptor_ui":"D011506","descriptor_name":"Proteins","qualifier_ui":"Q000737","qualifier_name":"chemistry","is_major_topic":false},{"descriptor_ui":"D011994","descriptor_name":"Recombinant Proteins","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":false},{"descriptor_ui":"D011994","descriptor_name":"Recombinant Proteins","qualifier_ui":"Q000494","qualifier_name":"pharmacology","is_major_topic":false},{"descriptor_ui":"D016503","descriptor_name":"Drug Delivery Systems","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":2,"locations":[{"id":"doi:10.2165/00003088-200544040-00001","doi":"https://doi.org/10.2165/00003088-200544040-00001","is_oa":false,"landing_page_url":"https://doi.org/10.2165/00003088-200544040-00001","pdf_url":null,"source":{"id":"https://openalex.org/S69290020","display_name":"Clinical Pharmacokinetics","issn_l":"0312-5963","issn":["0312-5963","1179-1926"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-b","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","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":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Pharmacokinetics","raw_type":"journal-article"},{"id":"pmid:15828849","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/15828849","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":"Clinical pharmacokinetics","raw_type":"Journal Article"}],"best_oa_location":null,"sustainable_development_goals":[{"score":0.8048999905586243,"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":82,"referenced_works":["https://openalex.org/W92324936","https://openalex.org/W111605662","https://openalex.org/W165360772","https://openalex.org/W192698215","https://openalex.org/W194230369","https://openalex.org/W601839786","https://openalex.org/W622829001","https://openalex.org/W624584325","https://openalex.org/W1515288612","https://openalex.org/W1541759393","https://openalex.org/W1548230107","https://openalex.org/W1562132062","https://openalex.org/W1586699825","https://openalex.org/W1751983523","https://openalex.org/W1875354643","https://openalex.org/W1917957682","https://openalex.org/W1966316431","https://openalex.org/W1971346846","https://openalex.org/W1973128971","https://openalex.org/W1975978239","https://openalex.org/W1977355715","https://openalex.org/W1982654585","https://openalex.org/W1984763603","https://openalex.org/W1985322017","https://openalex.org/W1986859181","https://openalex.org/W1990614415","https://openalex.org/W1994016083","https://openalex.org/W1998169782","https://openalex.org/W2005150551","https://openalex.org/W2006901707","https://openalex.org/W2007854893","https://openalex.org/W2010506651","https://openalex.org/W2012879547","https://openalex.org/W2015228718","https://openalex.org/W2016474992","https://openalex.org/W2016618962","https://openalex.org/W2019631412","https://openalex.org/W2035141021","https://openalex.org/W2038600527","https://openalex.org/W2040352436","https://openalex.org/W2046478287","https://openalex.org/W2048012100","https://openalex.org/W2048934315","https://openalex.org/W2059827743","https://openalex.org/W2064390254","https://openalex.org/W2067132822","https://openalex.org/W2070598185","https://openalex.org/W2074492486","https://openalex.org/W2076783617","https://openalex.org/W2077563872","https://openalex.org/W2078380224","https://openalex.org/W2080199877","https://openalex.org/W2084780834","https://openalex.org/W2097839908","https://openalex.org/W2102674639","https://openalex.org/W2104278356","https://openalex.org/W2105036599","https://openalex.org/W2107065429","https://openalex.org/W2119496393","https://openalex.org/W2127728541","https://openalex.org/W2133816590","https://openalex.org/W2140700267","https://openalex.org/W2150675831","https://openalex.org/W2155585300","https://openalex.org/W2162611042","https://openalex.org/W2164145268","https://openalex.org/W2171612134","https://openalex.org/W2190923290","https://openalex.org/W2273221906","https://openalex.org/W2307147645","https://openalex.org/W2324227497","https://openalex.org/W2336139768","https://openalex.org/W2339233285","https://openalex.org/W2416886890","https://openalex.org/W2431442613","https://openalex.org/W2627915450","https://openalex.org/W2723596987","https://openalex.org/W2808507257","https://openalex.org/W2811048929","https://openalex.org/W2992995566","https://openalex.org/W4285719527","https://openalex.org/W4406984652"],"related_works":["https://openalex.org/W2026650973","https://openalex.org/W2070194206","https://openalex.org/W1986852088","https://openalex.org/W2759533150","https://openalex.org/W1990614415","https://openalex.org/W2259916972","https://openalex.org/W21021756","https://openalex.org/W1986016424","https://openalex.org/W2084666587","https://openalex.org/W2047468814"],"abstract_inverted_index":null,"counts_by_year":[{"year":2026,"cited_by_count":3},{"year":2025,"cited_by_count":7},{"year":2024,"cited_by_count":8},{"year":2023,"cited_by_count":11},{"year":2022,"cited_by_count":4},{"year":2021,"cited_by_count":6},{"year":2020,"cited_by_count":7},{"year":2019,"cited_by_count":7},{"year":2017,"cited_by_count":7},{"year":2016,"cited_by_count":8},{"year":2015,"cited_by_count":8},{"year":2014,"cited_by_count":4},{"year":2013,"cited_by_count":13},{"year":2012,"cited_by_count":10}],"updated_date":"2026-11-07T11:25:07.637180","created_date":"2016-06-24T00:00:00"}