{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T16:23:55Z","timestamp":1792859035435,"version":"4.5.0"},"reference-count":17,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2014,2,17]],"date-time":"2014-02-17T00:00:00Z","timestamp":1392595200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2014,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:label\/><jats:p>Amenamevir is the international non\u2010proprietary name for ASP2151 synthesized by Astellas Pharma, Inc. It is a structurally novel class of helicase\u2010primase inhibitor and demonstrated more potency in vitro anti\u2010viral activity with low cytotoxicity against varicella\u2010zoster virus (VZV), herpes simplex virus type 1 (HSV\u20101), and herpes simplex virus type 2 (HSV\u20102) than acyclovir (ACV). Phase II randomized trial assessed the safety and efficacy of ASP2151 for episodic therapy of recurrent genital herpes was conducted. Participants self\u2010initiated with ASP2151 (100, 200, or 400\u2009mg daily for 3 days), ASP2151 (1,200\u2009mg as a single dose), placebo for 3 days, or Valacyclovir (500\u2009mg twice daily for 3 days). We present a first population pharmacokinetic (PPK) modeling analysis of Amenamevir for genital herpes patients. The final model retained the effect of Weight and Albumin on CL. Statistical analysis between pharmacokinetics and clinical efficacies was done by using the time above 200\u2009ng\/mL (T<jats:sub>200<\/jats:sub>). T<jats:sub>200<\/jats:sub> derived from the final PPK model to consider the correlation with Time to lesion healing and viral shedding. This finding suggested that it could be necessary to maintain the Amenamevir concentration above the threshold level to prevent the virus replication.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cpdd.108","type":"journal-article","created":{"date-parts":[[2014,1,22]],"date-time":"2014-01-22T05:58:43Z","timestamp":1390370323000},"page":"365-370","source":"Crossref","is-referenced-by-count":9,"title":["Statistical analysis of Amenamevir (ASP2151) between pharmacokinetics and clinical efficacies with non\u2010linear effect model for the treatment of genital herpes"],"prefix":"10.1002","volume":"3","author":[{"given":"Akitsugu","family":"Takada","sequence":"first","affiliation":[{"name":"Astellas Pharma, Inc. Itabashi\u2010ku Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masataka","family":"Katashima","sequence":"additional","affiliation":[{"name":"Astellas Pharma, Inc. Itabashi\u2010ku Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsunori","family":"Kaibara","sequence":"additional","affiliation":[{"name":"Astellas Pharma, Inc. Itabashi\u2010ku Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taiji","family":"Sawamoto","sequence":"additional","affiliation":[{"name":"Astellas Pharma, Inc. 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International Valaciclovir HSV Study Group","volume":"73","author":"Bodsworth NJ","year":"1997","journal-title":"Genitourin Med."},{"key":"e_1_2_7_11_1","unstructured":"BealL SheinerB.NONMEM Users Guide UCSF.: NONMEM Project Group; 1989."},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmpb.2005.02.003"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10928-007-9060-6"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10928-007-9081-1"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa035144"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199509213331205"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200003233421203"},{"key":"e_1_2_7_18_1","first-page":"66","article-title":"Is viral shedding a surrogate marker for transmission of genital herpes? 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