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It is also the key to describing variability in drug response caused by drug\u2010drug interactions (DDIs), pharmacogenetics, impaired kidney and liver function, etc. This tutorial aims to provide a guideline and step\u2010by\u2010step tutorial on essential considerations when designing clinical pharmacokinetic studies and reporting results. This includes a comprehensive guide on how to conduct the statistical analysis and a complete code for the statistical software R. As an example, we created a mock dataset simulating a clinical pharmacokinetic DDI study with 12 subjects who were administered 2\u2009mg oral midazolam with and without an inducer of cytochrome P450 3A. We provide a step\u2010by\u2010step guide to the statistical analysis of this clinical pharmacokinetic study, including sample size\/power calculation, descriptive statistics, noncompartmental analyses, and hypothesis testing. The different analyses and parameters are described in detail, and we provide a complete R code ready to use in <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"#cts13305-supitem-0001\">supplementary files<\/jats:ext-link>. Finally, we discuss important considerations when designing and reporting clinical pharmacokinetic studies. The scope of this tutorial is not limited to DDI studies, and with minor adjustments, it applies to all types of clinical pharmacokinetic studies. This work was done by early career researchers for early career researchers. We hope this tutorial may help early career researchers when getting started on their own pharmacokinetic studies. We encourage you to use this as an inspiration and starting point and continuously evolve your statistical skills.<\/jats:p>","DOI":"10.1111\/cts.13305","type":"journal-article","created":{"date-parts":[[2022,5,16]],"date-time":"2022-05-16T03:53:40Z","timestamp":1652673220000},"page":"1856-1866","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Tutorial: Statistical analysis and reporting of clinical pharmacokinetic studies"],"prefix":"10.1111","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7574-0909","authenticated-orcid":false,"given":"Ann\u2010Cathrine Dalg\u00e5rd","family":"Dunvald","sequence":"first","affiliation":[{"name":"Clinical Pharmacology, Pharmacy, and Environmental Medicine, Department of Public Health University of Southern Denmark  Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5519-9091","authenticated-orcid":false,"given":"Ditte Bork","family":"Iversen","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Pharmacy, and Environmental Medicine, Department of Public Health University of Southern Denmark  Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8050-6447","authenticated-orcid":false,"given":"Andreas Ludvig Ohm","family":"Svendsen","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Pharmacy, and Environmental Medicine, Department of Public Health University of Southern Denmark  Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4961-4797","authenticated-orcid":false,"given":"Katrine","family":"Agergaard","sequence":"additional","affiliation":[{"name":"Department of Regional Health Research University of Southern Denmark  Odense Denmark"},{"name":"Department of Nephrology Odense University Hospital  Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ida Berglund","family":"Kuhlmann","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Pharmacy, and Environmental Medicine, Department of Public Health University of Southern Denmark  Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9983-9196","authenticated-orcid":false,"given":"Christina","family":"Mortensen","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Pharmacy, and Environmental Medicine, Department of Public Health University of Southern Denmark  Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5750-8911","authenticated-orcid":false,"given":"Nanna Elman","family":"Andersen","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Pharmacy, and Environmental Medicine, Department of Public Health University of Southern Denmark  Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8970-5194","authenticated-orcid":false,"given":"Erkka","family":"J\u00e4rvinen","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Pharmacy, and Environmental Medicine, Department of Public Health University of Southern Denmark  Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4698-4389","authenticated-orcid":false,"given":"Tore Bjerregaard","family":"Stage","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Pharmacy, and Environmental Medicine, Department of Public Health University of Southern Denmark  Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,6]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/bph.12856"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.119.090027"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.1435"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2270"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.2174\/1381612823666170207100724"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13609"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmpb.2016.01.013"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics9020014"},{"key":"e_1_2_9_10_1","unstructured":"Guideline on the investigation of Bioequvalence [Internet].https:\/\/www.ema.europa.eu\/en\/documents\/scientific\u2010guideline\/guideline\u2010investigation\u2010bioequivalence\u2010rev1_en.pdf. 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