{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,29]],"date-time":"2025-12-29T11:31:30Z","timestamp":1767007890005,"version":"3.48.0"},"reference-count":28,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2025,8,21]],"date-time":"2025-08-21T00:00:00Z","timestamp":1755734400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["CPT Pharmacom &amp;amp; Syst Pharma"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Pegbing (peginterferon alpha\u20102b) is a polyethylene glycol\u2010modified interferon \u03b1\u20102b injection that has demonstrated favorable efficacy and safety profiles in the treatment of chronic hepatitis B (CHB). This study aimed to develop a population pharmacokinetic (PopPK) model of Pegbing in both healthy subjects and CHB patients and to investigate the influence of covariates on its pharmacokinetic behavior. Pharmacokinetic data were obtained from a Phase I trial in healthy volunteers and a Phase II trial in CHB patients. A one\u2010compartment model with a target\u2010mediated drug disposition (TMDD) component incorporating IFN receptor downregulation was established to describe the pooled data from 28 healthy subjects and 39 CHB patients. Physiologically reasonable parameters were estimated, providing a good description and prediction of the model. Furthermore, the final PopPK model was externally validated using an independent dataset of 115 CHB patients. In the covariate analysis, health status (healthy v.s. CHB) was a significant covariate, affecting the Pegbing absorption rate, creatinine clearance was associated with clearance, and body weight affected the volume of distribution. Compared with healthy subjects, CHB patients exhibited a consistent area under the curve (AUC) but a higher\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    . A PopPK model of Pegbing in both healthy volunteers and CHB patients was successfully established. Based on the model simulation, covariate\u2010based dose adjustment is unnecessary for CHB patients with normal renal function.\n                  <\/jats:p>","DOI":"10.1002\/psp4.70104","type":"journal-article","created":{"date-parts":[[2025,8,21]],"date-time":"2025-08-21T11:46:13Z","timestamp":1755776773000},"page":"2014-2025","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Population Pharmacokinetic Model of Pegbing in Healthy Subjects and Chronic Hepatitis B Patients"],"prefix":"10.1002","volume":"14","author":[{"given":"Weizhe","family":"Jian","sequence":"first","affiliation":[{"name":"Department of Pharmaceutics, School of Pharmaceutical Sciences Peking University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yalin","family":"Yin","sequence":"additional","affiliation":[{"name":"Xiamen Amoytop Biotech Co., LTD  Xiamen China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rong","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutics, School of Pharmaceutical Sciences Peking University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pingyao","family":"Luo","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutics, School of Pharmaceutical Sciences Peking University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tianyu","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutics, School of Pharmaceutical Sciences Peking University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jianbo","family":"Gu","sequence":"additional","affiliation":[{"name":"Xiamen Amoytop Biotech Co., LTD  Xiamen China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhengfang","family":"Du","sequence":"additional","affiliation":[{"name":"Xiamen Amoytop Biotech Co., LTD  Xiamen China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lei","family":"Cai","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutics, School of Pharmaceutical Sciences Peking University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tianyu","family":"Bao","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutics, School of Pharmaceutical Sciences Peking University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Junsheng","family":"Xue","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutics, School of Pharmaceutical Sciences Peking University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruoyi","family":"He","sequence":"additional","affiliation":[{"name":"Xiamen Amoytop Biotech Co., LTD  Xiamen China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2583-8080","authenticated-orcid":false,"given":"Tianyan","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutics, School of Pharmaceutical Sciences Peking University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,8,21]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"\u201cPegbing (Pegintereron Alfa\u20102b) Package Insert \u201dhttps:\/\/www.cde.org.cn\/main\/xxgk\/postmarketpage?acceptidCODE=f194acc5220254c4df5c062e040f2244."},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrd1033"},{"key":"e_1_2_11_4_1","first-page":"589","article-title":"Clinical Effect and Safety of Pegylated Interferon\u2010\u03b1\u20102b Injection (Y Shape, 40 kD) in Treatment of HBeAg\u2010Positive Chronic Hepatitis B Patients","volume":"25","author":"Hou F.","year":"2017","journal-title":"Zhonghua Gan Zang Bing Za Zhi"},{"issue":"6","key":"e_1_2_11_5_1","first-page":"1425","article-title":"Guidelines for the Prevention and Treatment of Chronic Hepatitis B (Version 2022)","volume":"11","author":"You H.","year":"2023","journal-title":"Journal of Clinical and Translational Hepatology"},{"key":"e_1_2_11_6_1","unstructured":"\u201cGuidelines for the Prevention Diagnosis Care and Treatment for People With Chronic Hepatitis B Infection \u201d(2024)."},{"key":"e_1_2_11_7_1","unstructured":"G.Wang \u201cPeginterferon Alpha\u20102b Combined With TDF Promotes Durable HBsAg Loss in Patients With Chronic Hepatitis B: A Multicentre Randomized Controlled Phase 3 Clinical Trial \u201dSan Diego California 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