{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,16]],"date-time":"2026-01-16T02:13:55Z","timestamp":1768529635901,"version":"3.49.0"},"reference-count":9,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2013,3,7]],"date-time":"2013-03-07T00:00:00Z","timestamp":1362614400000},"content-version":"vor","delay-in-days":218,"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":[[2012,8]]},"abstract":"<jats:p>Paricalcitol injection and capsules are approved for the prevention and treatment of secondary hyperparathyroidism. Exposure\u2010response analyses were performed to describe paricalcitol pharmacokinetics and the relationship to clinical responses (intact parathyroid hormone [iPTH], serum calcium, and phosphorus) following administration of paricalcitol capsules or injection to patients with chronic kidney disease (stage 5). Paricalcitol pharmacokinetics were similar following intravenous and oral administration with mean oral clearance of 1.75 L\/h and bioavailability of 75.1%. Exposure\u2014clinical response was best described by an indirect effects model where serum iPTH, calcium, and phosphorus production rates were directly affected by paricalcitol. Significant covariates in the response model included screening iPTH, calcium, and phosphorus on their corresponding synthesis rates; age on iPTH EC<jats:sub>50<\/jats:sub>; and bone\u2014specific alkaline phosphatase on calcium EC<jats:sub>50<\/jats:sub> (CRIT). This exposure\u2010response model was used in extensive clinical trial simulations to assess alternative dose regimens for CKD stage 5 patients.<\/jats:p>","DOI":"10.1177\/0091270011412966","type":"journal-article","created":{"date-parts":[[2011,9,23]],"date-time":"2011-09-23T07:46:21Z","timestamp":1316763981000},"page":"1162-1173","source":"Crossref","is-referenced-by-count":1,"title":["Exposure\u2014Clinical Response Analysis of Paricalcitol in Patients With Chronic Kidney Disease (Stage 5) on Hemodialysis or Peritoneal Dialysis"],"prefix":"10.1002","volume":"52","author":[{"given":"Peter A.","family":"Noertersheuser","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rajendra S.","family":"Pradhan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheri E.","family":"Klein","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura A.","family":"Williams","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rameshraja","family":"Palaparthy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tushar S.","family":"Garimella","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olaf","family":"Lichtenberger","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Walid M.","family":"Awni","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,3,7]]},"reference":[{"key":"e_1_2_6_2_2","first-page":"245","article-title":"Calcitriol oral therapy for the prevention of secondary hyperparathyroidism in patients with predialytic renal failure","volume":"49","author":"Panichi V","year":"1998","journal-title":"Clin Nephrol"},{"key":"e_1_2_6_3_2","doi-asserted-by":"crossref","first-page":"1427","DOI":"10.1681\/ASN.V981427","article-title":"19\u2010Nor\u20101\u2010alpha\u201025\u2010dihydroxyvitamin D2 (paricalcitol) safely and effectively reduces the levels of intact parathyroid hormone in patients on hemodialysis","volume":"9","author":"Martin KJ","year":"1998","journal-title":"J Am Soc Nephrol"},{"key":"e_1_2_6_4_2","volume-title":"Zemplar capsule [package insert]","year":"2010"},{"key":"e_1_2_6_5_2","doi-asserted-by":"publisher","DOI":"10.1159\/000109398"},{"key":"e_1_2_6_6_2","doi-asserted-by":"publisher","DOI":"10.1002\/bdd.532"},{"key":"e_1_2_6_7_2","doi-asserted-by":"publisher","DOI":"10.1053\/ajkd.2001.28112"},{"key":"e_1_2_6_8_2","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1D374"},{"key":"e_1_2_6_9_2","first-page":"770A","article-title":"Assessment of the absolute bioavailability of paricalcitol capsule (Zemplar\u2122) in subjects with end stage renal disease","volume":"12","author":"Qui P","year":"2001","journal-title":"J Am Soc Nephrol"},{"key":"e_1_2_6_10_2","unstructured":"AkizawaT AkibaT SuzukiM et al.Pharmacokinetics of paricalcitol a selective VDR (vitamin D receptor) activator are similar between Japanese and US subjects.http:production\u2010isn.nature.commedia1248354578.pdf."}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1177%2F0091270011412966","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1177\/0091270011412966","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,30]],"date-time":"2023-10-30T09:22:56Z","timestamp":1698657776000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1177\/0091270011412966"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,8]]},"references-count":9,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2012,8]]}},"alternative-id":["10.1177\/0091270011412966"],"URL":"https:\/\/doi.org\/10.1177\/0091270011412966","archive":["Portico"],"relation":{},"ISSN":["0091-2700","1552-4604"],"issn-type":[{"value":"0091-2700","type":"print"},{"value":"1552-4604","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,8]]}}}