{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,7]],"date-time":"2026-02-07T04:00:43Z","timestamp":1770436843093,"version":"3.49.0"},"reference-count":14,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2014,5,9]],"date-time":"2014-05-09T00:00:00Z","timestamp":1399593600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie Inc.","doi-asserted-by":"crossref","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}],"id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2014,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:label\/><jats:p>The pharmacokinetics (PK) and pharmacodynamics of two leuprolide acetate (LA) 45\u2009mg 6\u2010month depot formulations were characterized in prostate cancer patients. Subjects (planned N\u2009=\u2009150 in each cohort) received two intramuscular injections of LA Formulation\u2010A or Formulation\u2010B administered 24 weeks apart. Samples were collected for the measurement of testosterone, LH (all subjects) and leuprolide (in a subset of subjects approximately N\u2009=\u200924 in each cohort) at the same time points. Leuprolide PK profile showed an initial peak followed by a rapid decline over the first week post\u2010dose, with mean leuprolide concentrations staying relatively constant through the end of 24\u2010week period. Mean testosterone and LH serum concentrations showed initial increases above baseline values after the first dose and then decreased to 16.0\u2009ng\/dL and 0.6\u2009mIU\/mL by Week 4 for Formulation\u2010A and were maintained at \u226414.3\u2009ng\/dL and 0.4\u2009mIU\/mL, thereafter, with negligible mean increases after the second dose. Formulation\u2010A showed a lower initial peak and higher leuprolide concentration during the sustained release phase which may explain higher testosterone suppression rates for Formulation\u2010A compared to Formulation\u2010B. Differences in PK between LA depot formulations were reflected in pharmacodynamic responses, with a higher rate of testosterone suppression and less escapes and acute\u2010on\u2010chronic responses for Formulation\u2010A.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cpdd.112","type":"journal-article","created":{"date-parts":[[2014,2,19]],"date-time":"2014-02-19T07:12:39Z","timestamp":1392793959000},"page":"270-275","source":"Crossref","is-referenced-by-count":7,"title":["Evaluation of the pharmacokinetics and pharmacodynamics of two leuprolide acetate 45\u2009mg 6\u2010month depot formulations in patients with prostate cancer"],"prefix":"10.1002","volume":"3","author":[{"given":"Nael M.","family":"Mostafa","sequence":"first","affiliation":[{"name":"Pharmaceutical Development AbbVie Inc. North Chicago IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kristof","family":"Chwalisz","sequence":"additional","affiliation":[{"name":"Pharmaceutical Development AbbVie Inc. North Chicago IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lois","family":"Larsen","sequence":"additional","affiliation":[{"name":"Pharmaceutical Development AbbVie Inc. North Chicago IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cynthia","family":"Mattia\u2010Goldberg","sequence":"additional","affiliation":[{"name":"Pharmaceutical Development AbbVie Inc. North Chicago IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aaron","family":"Spitz","sequence":"additional","affiliation":[{"name":"South Orange County Medical Research Center Laguna Hills CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rajendra S.","family":"Pradhan","sequence":"additional","affiliation":[{"name":"Pharmaceutical Development AbbVie Inc. North Chicago IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2014,5,9]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijrobp.2006.04.029"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/1097-0142(19900415)65:8<1864::AID-CNCR2820650832>3.0.CO;2-U"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1677\/ERC-10-0187"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0090-4295(03)00330-3"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-199448060-00008"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/jps.2600750211"},{"key":"e_1_2_8_8_1","unstructured":"AbbVie. Study of a 6\u2010month sustained\u2010release formulation of leuprolide acetate in prostate cancer. In:ClinicalTrials.gov[Internet]. Bethesda (MD): National Library of Medicine (US). 2000 [cited 2014 Jan 6]. Available from:http:\/\/clinicaltrials.gov\/show\/NCT00056654 NLM Identifier: NCT00056654."},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2006-1864"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/pcan.2011.50"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.2147\/CMAR.S12700"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1159\/000056547"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1159\/000056540"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0168-3659(01)00248-6"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1517\/17425247.5.6.615"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fcpdd.112","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.112","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,6]],"date-time":"2023-10-06T22:42:47Z","timestamp":1696632167000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.112"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,5,9]]},"references-count":14,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2014,7]]}},"alternative-id":["10.1002\/cpdd.112"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.112","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,5,9]]}}}