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This lack of data is mainly due to ethico\u2010legal challenges that have remained entrenched in the post\u2010diethylstilbestrol and thalidomide era, and that have led to pregnancy being viewed in the clinical trial setting primarily through a pharmacovigilance lens. Policy considerations that encourage and\/or require the inclusion of pregnant or lactating women in clinical trials may address the current lack of available information. However, there are additional pragmatic strategies, such the employment of pharmacometric tools and the introduction of innovative clinical trial designs, which could improve knowledge about the safety and efficacy of medication use during pregnancy and lactation. This paper provides a broad overview of the pharmacoepidemiology of drugs used during pregnancy and lactation, and offers recommendations for regulators and researchers in academia and industry to increase the available pharmacokinetic and \u2010dynamic understanding of medication use in pregnancy.<\/jats:p>","DOI":"10.1111\/bcp.13438","type":"journal-article","created":{"date-parts":[[2017,9,19]],"date-time":"2017-09-19T05:26:48Z","timestamp":1505798808000},"page":"215-222","source":"Crossref","is-referenced-by-count":75,"title":["Inclusion of pregnant and breastfeeding women in research \u2013 efforts and initiatives"],"prefix":"10.1111","volume":"84","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3245-1626","authenticated-orcid":false,"given":"S\u00edlvia M.","family":"Illamola","sequence":"first","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Pediatrics University of Utah School of Medicine Salt Lake City UT USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Bucci\u2010Rechtweg","sequence":"additional","affiliation":[{"name":"Pediatric &amp; Maternal Health Policy, Global Drug Regulatory Affairs Novartis Pharmaceuticals Corporation East Hanover New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maged M.","family":"Costantine","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Division of Maternal\u2010Fetal Medicine University of Texas Medical Branch Galveston TX USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ekaterini","family":"Tsilou","sequence":"additional","affiliation":[{"name":"Obstetric and Pediatric Pharmacology and Therapeutics Branch at the Eunice Kennedy Shriver National Institute of Child Health and Human Development Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0844-3207","authenticated-orcid":false,"given":"Catherine M.","family":"Sherwin","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Pediatrics University of Utah School of Medicine Salt Lake City UT USA"},{"name":"Department of Pharmacotherapy University of Utah College of Pharmacy Salt Lake City UT USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Zajicek","sequence":"additional","affiliation":[{"name":"Obstetric and Pediatric Pharmacology and Therapeutics Branch at the Eunice Kennedy Shriver National Institute of Child Health and Human Development Bethesda MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,10,22]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1013961"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/bdrc.21096"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1067\/mob.2002.125740"},{"key":"e_1_2_7_5_1","first-page":"39406","article-title":"Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs; notice","volume":"58","author":"US Food and Drug Administration","year":"1993","journal-title":"Fed Regist"},{"key":"e_1_2_7_6_1","first-page":"37434","article-title":"Labeling and prescription drug advertising: content and format for labeling for human prescription drugs","volume":"44","author":"US Food and Drug Administration","year":"1979","journal-title":"Fed Regist"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2125.2003.01865.x"},{"key":"e_1_2_7_8_1","doi-asserted-by":"crossref","first-page":"435","DOI":"10.1016\/S0022-3565(24)39253-5","article-title":"Comparative kinetics and response to the benzodiazepine agonists triazolam and zolpidem: evaluation of sex\u2010dependent differences","volume":"293","author":"Greenblatt DJ","year":"2000","journal-title":"J Pharmacol Exp Ther"},{"key":"e_1_2_7_9_1","unstructured":"National Institutes of Health Revitalization Act of 1993. 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