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Ceftazidime\u2010avibactam is a novel \u03b2\u2010lactam \u03b2\u2010lactamase inhibitor combination approved for adults and children 3\u00a0months and older with complicated intra\u2010abdominal infection, and complicated urinary tract infection or hospital\u2010acquired ventilator\u2010associated pneumonia (adults only in the United States) caused by susceptible gram\u2010negative bacteria. Extensive population pharmacokinetic (PK) data sets for ceftazidime and avibactam obtained during the adult clinical development program were used to iteratively select, modify, and validate the approved adult dosage regimen (2,000\u2013500\u00a0mg by 2\u2010hour intravenous (IV) infusion every 8\u00a0hours (q8h), with adjustments for renal function). Following the completion of one phase I (NCT01893346) and two phase II ceftazidime\u2010avibactam studies (NCT02475733 and NCT02497781) in children, adult PK data sets were updated with pediatric PK data. This paper describes the development of updated combined adult and pediatric population PK models and their application in characterizing the population PK of ceftazidime and avibactam in children, and in dose selection for further pediatric evaluation. The updated models supported the approval of ceftazidime\u2010avibactam pediatric dosage regimens (all by 2\u2010hour IV infusion) of 50\u201312.5\u00a0mg\/kg (maximum 2,000\u2013500\u00a0mg) q8h for those \u22656\u00a0months to 18\u00a0years old, and 40\u201310\u00a0mg\/kg q8h for those \u22653 to 6\u00a0months old with creatinine clearance &gt; 50\u00a0mL\/min\/1.73 m<jats:sup>2<\/jats:sup>.<\/jats:p>","DOI":"10.1002\/cpt.2460","type":"journal-article","created":{"date-parts":[[2021,10,23]],"date-time":"2021-10-23T18:42:00Z","timestamp":1635014520000},"page":"635-645","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Population Pharmacokinetic Modeling and Probability of Pharmacodynamic Target Attainment for Ceftazidime\u2010Avibactam in Pediatric Patients Aged 3 Months and Older"],"prefix":"10.1111","volume":"111","author":[{"given":"Richard C.","family":"Franzese","sequence":"first","affiliation":[{"name":"Certara Strategic Consulting Raleigh North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lynn","family":"McFadyen","sequence":"additional","affiliation":[{"name":"Pfizer Sandwich, Kent UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenny J.","family":"Watson","sequence":"additional","affiliation":[{"name":"Certara Strategic Consulting Sheffield UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Todd","family":"Riccobene","sequence":"additional","affiliation":[{"name":"AbbVie Madison New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy J.","family":"Carrothers","sequence":"additional","affiliation":[{"name":"AbbVie Madison New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manoli","family":"Vourvahis","sequence":"additional","affiliation":[{"name":"Pfizer New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phylinda L.S.","family":"Chan","sequence":"additional","affiliation":[{"name":"Pfizer Sandwich, Kent UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Raber","sequence":"additional","affiliation":[{"name":"Pfizer La Jolla California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John S.","family":"Bradley","sequence":"additional","affiliation":[{"name":"Rady Children\u2019s Hospital\/University of California San Diego School of Medicine San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Lovern","sequence":"additional","affiliation":[{"name":"Certara Strategic Consulting Raleigh North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,11,22]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1089\/mdr.2015.0220"},{"key":"e_1_2_11_3_1","unstructured":"European Centre for Disease Prevention and Control.Antimicrobial resistance in the EU\/EEA (EARS\u2010Net): Annual Epidemiological Report for 2019<https:\/\/www.ecdc.europa.eu\/sites\/default\/files\/documents\/surveillance\u2010antimicrobial\u2010resistance\u2010Europe\u20102019.pdf> (2020)."},{"key":"e_1_2_11_4_1","unstructured":"Centers for Disease Control and Prevention.Antibiotic Resistance Threats in the United States 2019 (2019 AR Threats Report)<https:\/\/www.cdc.gov\/drugresistance\/pdf\/threats\u2010report\/2019\u2010ar\u2010threats\u2010report\u2010508.pdf> (2019)."},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/jpids\/piw093"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02183-19"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkaa397"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/jpids\/piz085"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.2147\/CE.S40698"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijantimicag.2011.09.012"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkp197"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkq161"},{"key":"e_1_2_11_13_1","unstructured":"Zavicefta [summary of product characteristics]. (Pfizer Ireland Pharmaceuticals Ringaskiddy Ireland 2021). (https:\/\/www.ema.europa.eu\/documents\/product\u2010information\/zavicefta\u2010epar\u2010product\u2010information_en.pdf)."},{"key":"e_1_2_11_14_1","unstructured":"Avycaz [highlights of prescribing information]. 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