{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,18]],"date-time":"2025-10-18T20:51:43Z","timestamp":1760820703758},"reference-count":11,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2015,6,18]],"date-time":"2015-06-18T00:00:00Z","timestamp":1434585600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"GSK"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2015,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:label \/><jats:p>The objective of the present work was to use modeling and simulation to inform trial design of a proof\u2010of\u2010concept study for agents used in the treatment of hyperhidrosis. Data were available from 36 subjects who received the vehicle, 2% or 4% topical glycopyrrolate wipes daily for 4 weeks, with response (hyperhidrosis disease severity scale [HDSS] and sweat production [SP]) measured weekly. The HDSS and SP time courses were best described using a longitudinal model with maximum response achieved by 1 week. Glycopyrrolate 4% had a higher HDSS responder rate than 2% (50% vs 33%) and placebo (0%) at week 1. Mean change from baseline (mg\/5\u2009min [SD]) in SP at week 1 was \u201090 (220), \u2010185 (214), and \u2010271 (265) for placebo, 2%, and 4% glycopyrrolate, respectively. Subjects with higher baseline SP had higher sweat reduction from baseline. Virtual clinical trials were simulated and analyzed using conventional (at the end of the study) versus model\u2010based methods to determine sample size for achieving 80% power to identify a dose\u2013response relationship. Twenty\u2010seven subjects compared with at least 120 subjects would be needed using model\u2010based and conventional methods, respectively. Thus, the model\u2010based method using longitudinal data required fewer subjects than the conventional single\u2010point method.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcph.536","type":"journal-article","created":{"date-parts":[[2015,5,1]],"date-time":"2015-05-01T22:45:10Z","timestamp":1430520310000},"page":"1256-1267","source":"Crossref","is-referenced-by-count":9,"title":["Pharmacometrics\u2010guided drug development of antihyperhidrosis agents"],"prefix":"10.1002","volume":"55","author":[{"given":"Shailly","family":"Mehrotra","sequence":"first","affiliation":[{"name":"Center for Translation Medicine, School of Pharmacy University of Maryland Baltimore MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Virginia D.","family":"Schmith","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Modeling and Simulation GlaxoSmithKline (GSK) Research Triangle Park NC USA"},{"name":"Presently at Nuventra Pharma Sciences"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Teodora Pene","family":"Dumitrescu","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Modeling and Simulation GlaxoSmithKline (GSK) Research Triangle Park NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jogarao","family":"Gobburu","sequence":"additional","affiliation":[{"name":"Center for Translation Medicine, School of Pharmacy University of Maryland Baltimore MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,6,18]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2003.12.040"},{"issue":"5","key":"e_1_2_12_3_1","doi-asserted-by":"crossref","first-page":"642","DOI":"10.1213\/00000539-197709000-00008","article-title":"Control of gastric acidity by glycopyrrolate premedication in the parturient","volume":"56","author":"Baraka A","year":"1977","journal-title":"Anesth Analg."},{"key":"e_1_2_12_4_1","unstructured":"FDA Glycopyrrolate oral solution (NDA 22\u2010571) Medical Review(s).http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2010\/022571Orig1s000MedR.pdf."},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.3344\/kjp.2012.25.1.28"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.12518"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2003.10.202"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4725.2012.02375.x"},{"key":"e_1_2_12_9_1","first-page":"S83","article-title":"Modeling of investigative static global assessment score (ISGA) in acne vulgaris","volume":"91","author":"Singh RP","year":"2012","journal-title":"Clin Pharm Ther."},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1208\/aapsj070353"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/psp.2012.24"},{"issue":"2","key":"e_1_2_12_12_1","doi-asserted-by":"crossref","first-page":"226","DOI":"10.1152\/jappl.1975.39.2.226","article-title":"Circadian variations in the sweating mechanism","volume":"39","author":"Timbal J","year":"1975","journal-title":"J Appl Physiol."}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fjcph.536","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.536","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,6]],"date-time":"2023-10-06T14:47:11Z","timestamp":1696603631000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/jcph.536"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,6,18]]},"references-count":11,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2015,11]]}},"alternative-id":["10.1002\/jcph.536"],"URL":"https:\/\/doi.org\/10.1002\/jcph.536","archive":["Portico"],"relation":{},"ISSN":["0091-2700","1552-4604"],"issn-type":[{"value":"0091-2700","type":"print"},{"value":"1552-4604","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,6,18]]}}}