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Physiological changes during pregnancy often result in lower drug exposures of antiretrovirals, and in some cases a risk of reduced virologic efficacy. The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) network and the World Health Organization (WHO)\u2013convened Pediatric Antiretrovirals Working Group collaboratively organized a workshop of key stakeholders in June 2019 to define key standards to generate pharmacology data for antiretrovirals to be used among pregnant and lactating women; review the antiretroviral product pipeline; describe key gaps for use in low\u2010income and middle\u2010income countries; and identify opportunities to undertake optimal studies allowing for rapid implementation in the clinical field. We discussed ethical and regulatory principles, systemic approaches to obtaining data for pregnancy pharmacokinetic\/pharmacodynamic (PK\/PD) studies, control groups, optimal sampling times during pregnancy, and pharmacokinetic parameters to be considered as primary end points in pregnancy PK\/PD studies. For lactation studies, the type of milk to collect, ascertainment of maternal adherence, and optimal PK methods to estimate exposure were discussed. Participants strongly recommended completion of preclinical reproductive toxicology studies prior to phase III, to allow study protocols to include pregnant women or to allow women who become pregnant after enrolment to continue in the trial. The meeting concluded by developing an algorithm for design and interpretation of results and noted that recruitment of pregnant and lactating women into clinical trials is critical.<\/jats:p>","DOI":"10.1002\/cpt.2048","type":"journal-article","created":{"date-parts":[[2020,9,16]],"date-time":"2020-09-16T20:19:42Z","timestamp":1600287582000},"page":"36-48","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":48,"title":["Optimizing Pharmacology Studies in Pregnant and Lactating Women Using Lessons From HIV: A Consensus Statement"],"prefix":"10.1111","volume":"110","author":[{"given":"Ahizechukwu C.","family":"Eke","sequence":"first","affiliation":[{"name":"Division of Maternal Fetal Medicine Department of Gynecology &amp; Obstetrics Johns Hopkins University School of Medicine Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adeniyi","family":"Olagunju","sequence":"additional","affiliation":[{"name":"Faculty of Pharmacy Obafemi Awolowo University Ile\u2010Ife Nigeria"},{"name":"Department of Molecular &amp; Clinical Pharmacology University of Liverpool Liverpool UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeremiah","family":"Momper","sequence":"additional","affiliation":[{"name":"Skaggs School of Pharmacy and Pharmaceutical Sciences University of California San Diego La Jolla California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martina","family":"Penazzato","sequence":"additional","affiliation":[{"name":"HIV, Hepatitis and STI Department World Health Organization Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elaine J.","family":"Abrams","sequence":"additional","affiliation":[{"name":"Mailman School of Public Health ICAP at Columbia University New York New York USA"},{"name":"Department of Pediatrics Vagelos College of Physicians &amp; Surgeons Columbia University New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brookie M.","family":"Best","sequence":"additional","affiliation":[{"name":"Skaggs School of Pharmacy and Pharmaceutical Sciences University of California San Diego La Jolla California USA"},{"name":"Pediatrics Department University of California San Diego School of Medicine\u2010Rady Children\u2019s Hospital San Diego San Diego California USA"},{"name":"University of Liverpool Liverpool UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edmund V.","family":"Capparelli","sequence":"additional","affiliation":[{"name":"Skaggs School of Pharmacy and Pharmaceutical Sciences University of California San Diego La Jolla California USA"},{"name":"Pediatrics Department University of California San Diego School of Medicine\u2010Rady Children\u2019s Hospital San Diego San Diego California USA"},{"name":"University of Liverpool Liverpool UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adrie","family":"Bekker","sequence":"additional","affiliation":[{"name":"Department of Paediatrics and Child Health Stellenbosch University Cape Town South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yodit","family":"Belew","sequence":"additional","affiliation":[{"name":"Division of Antiviral Products, US Food and Drug Administration (FDA) Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer J.","family":"Kiser","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences Aurora Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly","family":"Struble","sequence":"additional","affiliation":[{"name":"Division of Antiviral Products, US Food and Drug Administration (FDA) Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Graham","family":"Taylor","sequence":"additional","affiliation":[{"name":"Department of Infectious Disease Faculty of Medicine Imperial College London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catriona","family":"Waitt","sequence":"additional","affiliation":[{"name":"Department of HIV Pharmacology University of Liverpool Liverpool UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Mirochnick","sequence":"additional","affiliation":[{"name":"Boston University School of Medicine Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tim R.","family":"Cressey","sequence":"additional","affiliation":[{"name":"Department of Molecular &amp; Clinical Pharmacology University of Liverpool Liverpool UK"},{"name":"PHPT\/IRD UMI 174 Faculty of Associated Medical Sciences Chiang Mai University Chiang Mai Thailand"},{"name":"Department of Immunology &amp; Infectious Diseases Harvard T.H. Chan School of Public Health Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela","family":"Colbers","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Radboud Institute for Health Sciences Radboud University Medical Center Nijmegen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the participants of the WHO\u2010IMPAACT workshop on \u201cApproaches to Optimize and Accelerate Pharmacokinetic Studies in Pregnant and Lactating Women\u201d","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,10,15]]},"reference":[{"key":"e_1_2_12_1_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.382"},{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF01391748"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-pharmtox-011613-140009"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1053\/sper.2001.24565"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2004.08.030"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.00470112"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1331"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1080\/17425255.2019.1628947"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000001677"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0000000000001517"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12879-015-0914-z"},{"key":"e_1_2_12_12_1","unstructured":"Panel on treatment of pregnant women with HIV infection and prevention of perinatal transmission. 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