{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T19:02:26Z","timestamp":1790881346148,"version":"4.1.0"},"reference-count":18,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2013,3,7]],"date-time":"2013-03-07T00:00:00Z","timestamp":1362614400000},"content-version":"vor","delay-in-days":1161,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2010,1]]},"abstract":"<jats:p>Teduglutide is a GLP\u20102 analog currently evaluated for the treatment of short bowel syndrome, Crohn's disease, and other gastrointestinal disorders. The population pharmacokinetics (PK) of teduglutide were assessed following daily subcutaneous (SC) administrations of 2.5 to 80 mg doses in a total of 256 patients. A 1\u2010compartment model with a site\u2010specific rate constant of absorption in the abdomen, arm, and thigh was used to assess the PK of teduglutide. Apparent clearance (CL\/F) of teduglutide in male participants was approximately 18% higher than that observed in female participants (12.4 vs 10.5 L\/h, respectively). Body weight was detected as a significant covariate explaining the volume of distribution of teduglutide. The elimination half\u2010life (t<jats:sub>1\/2<\/jats:sub>) of teduglutide was also influenced by the body weight of participants. For a male patient weighing 50 and 90 kg, t<jats:sub>1\/2<\/jats:sub> of teduglutide was 0.897 and 2.99 hours, respectively. Renal and hepatic function of patients did not affect the PK of teduglutide. As a result, no dose adjustment was deemed necessary in patients with altered renal or liver function. The population PK model will help to support adequate drug labeling following SC administrations in patients and determine whether an individualized dosage is required.<\/jats:p>","DOI":"10.1177\/0091270009342252","type":"journal-article","created":{"date-parts":[[2009,9,23]],"date-time":"2009-09-23T02:29:58Z","timestamp":1253672998000},"page":"36-49","source":"Crossref","is-referenced-by-count":43,"title":["Population Pharmacokinetics of Teduglutide Following Repeated Subcutanenous Administrations in Healthy Participants and in Patients With Short Bowel Syndrome and Crohn's Disease"],"prefix":"10.1002","volume":"50","author":[{"given":"Jean\u2010Francois","family":"Marier","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamad\u2010Samer","family":"Mouksassi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathalie H.","family":"Gosselin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Beliveau","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane","family":"Cyran","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Wallens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2013,3,7]]},"reference":[{"key":"e_1_2_5_2_2","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.96.4.1569"},{"key":"e_1_2_5_3_2","doi-asserted-by":"publisher","DOI":"10.1152\/ajpendo.2000.278.1.E134"},{"key":"e_1_2_5_4_2","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v12.i26.4117"},{"key":"e_1_2_5_5_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2006.03193.x"},{"key":"e_1_2_5_6_2","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2004.061440"},{"key":"e_1_2_5_7_2","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1G419"},{"key":"e_1_2_5_8_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.309.6951.355"},{"key":"e_1_2_5_9_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.16.s4.16.x"},{"key":"e_1_2_5_10_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2001.03671.x"},{"key":"e_1_2_5_11_2","doi-asserted-by":"publisher","DOI":"10.1177\/0091270008320605"},{"key":"e_1_2_5_12_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11095-007-9361-x"},{"key":"e_1_2_5_13_2","doi-asserted-by":"publisher","DOI":"10.1023\/A:1011970125687"},{"key":"e_1_2_5_14_2","volume-title":"Guidance for Industry: Population Pharmacokinetics","year":"1999"},{"key":"e_1_2_5_15_2","unstructured":"Committee for Medicinal Products for Human Use (CHMP).Guideline on Reporting the Results of Population Pharmacokinetic Analyses. Doc. ref. CHMP\/EWP\/185990\/06.June 21 2007. Available athttp:www.emea.europa.eupdfshumanewp18599\u2010006enfin.pdf."},{"key":"e_1_2_5_16_2","volume-title":"Guidance for Industry: Exposure\u2010Response Relationships\u2014Study Design, Data Analysis, and Regulatory Applications","year":"2003"},{"key":"e_1_2_5_17_2","volume-title":"Guidance for Industry: Pharmacokinetics in Patients With Impaired Renal Function\u2014Study Design, Data Analysis, and Impact on Dosing and Labeling","year":"1998"},{"key":"e_1_2_5_18_2","unstructured":"A phase 1 randomized open\u2010label 3\u2010way crossover bioavailability study of 10 mg teduglutide in healthy adults. Protocol CL0600\u2010015 July 1 2005."},{"key":"e_1_2_5_19_2","doi-asserted-by":"publisher","DOI":"10.1023\/A:1018943613122"}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1177%2F0091270009342252","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1177\/0091270009342252","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,16]],"date-time":"2023-10-16T19:00:33Z","timestamp":1697482833000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1177\/0091270009342252"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2010,1]]},"references-count":18,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2010,1]]}},"alternative-id":["10.1177\/0091270009342252"],"URL":"https:\/\/doi.org\/10.1177\/0091270009342252","archive":["Portico"],"relation":{},"ISSN":["0091-2700","1552-4604"],"issn-type":[{"value":"0091-2700","type":"print"},{"value":"1552-4604","type":"electronic"}],"subject":[],"published":{"date-parts":[[2010,1]]}}}