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In Japan, the Evaluation Committee on Unapproved or Off\u2010labeled Drugs with High Medical Needs has discussed the necessity of pediatric indications against the background of a lack of Japanese pediatric data. The limited treatment options regarding antibiotics for pediatric patients are associated with the emergence of antibiotic\u2010resistant bacteria. Regulatory guidelines promote the use of model\u2010based drug development to reduce practical and ethical constraints for pediatric patients. Sampling optimization is one of the key study designs for pediatric drug development. In this simulation study, we evaluated the precision of the empirical Bayes estimates of pharmacokinetic (PK) parameters based on the sampling times optimized by published pediatric population PK models. We selected three previous PK studies of cefepime and ciprofloxacin in infants and young children as paradigms. The number of sampling times was reduced from original full sampling times to two to four sampling times based on the Fisher information matrix. We observed that the precision of empirical Bayes estimates of the key PK parameters and the predicted efficacy based on the reduced sampling times were generally comparable to those based on the original full sampling times. The model\u2010based approach to sampling optimization provided a maximization of PK information with a minimum burden on infants and young children for the future development of pediatric drugs.<\/jats:p>","DOI":"10.1111\/cts.13018","type":"journal-article","created":{"date-parts":[[2021,3,20]],"date-time":"2021-03-20T10:27:59Z","timestamp":1616236079000},"page":"1543-1553","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Model\u2010based approach to sampling optimization in studies of antibacterial drugs for infants and young children"],"prefix":"10.1111","volume":"14","author":[{"given":"Yuji","family":"Orito","sequence":"first","affiliation":[{"name":"Musashino University Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Makoto","family":"Kakara","sequence":"additional","affiliation":[{"name":"MSD K.K Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akira","family":"Okada","sequence":"additional","affiliation":[{"name":"Musashino University Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naomi","family":"Nagai","sequence":"additional","affiliation":[{"name":"Musashino University Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,4,9]]},"reference":[{"key":"e_1_2_9_2_1","first-page":"143","article-title":"Pediatric drug development in Japan from the perspective of academia","volume":"34","author":"Nakagawa M","year":"2018","journal-title":"J Clin Ther Med"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2016.01.012"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(04)16942-0"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.paed.2011.04.011"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2009.03591.x"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.2471\/BLT.10.080010"},{"key":"e_1_2_9_8_1","unstructured":"World Health Organization.Global priority list of antibiotic\u2010resistant bacteria to guide research discovery and development of new antibiotics.https:\/\/www.who.int\/medicines\/publications\/WHO\u2010PPL\u2010Short_Summary_25Feb\u2010ET_NM_WHO.pdf?ua=1. 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