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However, pregnant and lactating women are often excluded from primary pharmacokinetic studies and as such there is often limited dosing information regarding drug use in pregnant and\/or lactating women. The objectives of this interim analysis were to define the transfer of rifampicin to a breastfed infant and to determine the area under the concentration\u2013time curve of rifampicin in maternal plasma, breastmilk and infant plasma. Performing this interim analysis enabled us to substantiate whether prior assumptions we made on several study design issues including patient sample size and pharmacokinetic sampling times held and whether we needed to amend our protocol or not. We enrolled lactating mothers on treatment for tuberculosis with their breastfeeding infants (below 12\u2009months of age), performed intensive pharmacokinetic sampling (0\u201324\u2009h post\u2010dose) on plasma samples from both the mother, infant(s) and breastmilk samples from the mother on two separate occasions (once during the initiation phase and another during the continuation phase of tuberculosis treatment). The initial study design, including sampling times, was informed by a stochastic simulation and estimation exercise, with very limited prior breastmilk data. An interim analysis after recruiting 6 mother\u2013infant pairs ascertained that our initial assumptions were ideal for achieving our study objectives and no amendments to the sampling times were necessary. Initial data from 6 mother\u2013infant pairs show that rifampicin penetrates breastmilk with an approximate milk\u2010to\u2010plasma ratio of 0.169 and 0.189 on two separate visits. However, it was undetectable in most infants.<\/jats:p>","DOI":"10.1002\/psp4.13247","type":"journal-article","created":{"date-parts":[[2024,10,2]],"date-time":"2024-10-02T11:40:18Z","timestamp":1727869218000},"page":"1915-1923","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Interim analysis, a tool to enhance efficiency of pharmacokinetic studies: Pharmacokinetics of rifampicin in lactating mother\u2013infant pairs"],"prefix":"10.1002","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7975-0178","authenticated-orcid":false,"given":"Aida N.","family":"Kawuma","sequence":"first","affiliation":[{"name":"Infectious Diseases Institute Makerere University College of Health Sciences  Kampala Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6425-6828","authenticated-orcid":false,"given":"Francis Williams","family":"Ojara","sequence":"additional","affiliation":[{"name":"Infectious Diseases Institute Makerere University College of Health Sciences  Kampala Uganda"},{"name":"Department of Pharmacology and Therapeutics Gulu University  Gulu Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5874-3219","authenticated-orcid":false,"given":"Allan","family":"Buzibye","sequence":"additional","affiliation":[{"name":"Infectious Diseases Institute Makerere University College of Health Sciences  Kampala Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7756-5032","authenticated-orcid":false,"given":"Barbara","family":"Castelnuovo","sequence":"additional","affiliation":[{"name":"Infectious Diseases Institute Makerere University College of Health Sciences  Kampala Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9108-4331","authenticated-orcid":false,"given":"Jovia C.","family":"Tabwenda","sequence":"additional","affiliation":[{"name":"Infectious Diseases Institute Makerere University College of Health Sciences  Kampala Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0156-5615","authenticated-orcid":false,"given":"Jacqueline","family":"Kyeyune","sequence":"additional","affiliation":[{"name":"Infectious Diseases Institute Makerere University College of Health Sciences  Kampala Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6510-0887","authenticated-orcid":false,"given":"Christine","family":"Turyahabwe","sequence":"additional","affiliation":[{"name":"Infectious Diseases Institute Makerere University College of Health Sciences  Kampala Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9804-6079","authenticated-orcid":false,"given":"Simon Peter","family":"Asiimwe","sequence":"additional","affiliation":[{"name":"Infectious Diseases Institute Makerere University College of Health Sciences  Kampala Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1710-7042","authenticated-orcid":false,"given":"Johnson","family":"Magoola","sequence":"additional","affiliation":[{"name":"Infectious Diseases Institute Makerere University College of Health Sciences  Kampala Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9070-8699","authenticated-orcid":false,"given":"Lubbe","family":"Wiesner","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Medicine University of Cape Town  Cape Town South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6626-0329","authenticated-orcid":false,"given":"Ritah","family":"Nakijoba","sequence":"additional","affiliation":[{"name":"Infectious Diseases Institute Makerere University College of Health Sciences  Kampala Uganda"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0134-5855","authenticated-orcid":false,"given":"Catriona","family":"Waitt","sequence":"additional","affiliation":[{"name":"Infectious Diseases Institute Makerere University College of Health Sciences  Kampala Uganda"},{"name":"Department of Pharmacology and Therapeutics University of Liverpool  Liverpool UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,10,2]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"WHO.Infant and young child feeding.2021.https:\/\/www.who.int\/news\u2010room\/fact\u2010sheets\/detail\/infant\u2010and\u2010young\u2010child\u2010feeding. 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