title: Fetal and perinatal exposure to drugs and chemicals: novel biomarkers of risk.
abstract: Pregnant women are almost always excluded from randomized controlled clinical trials, as the risks to the fetus posed by most new chemical entities or approved drugs cannot be sufficiently ruled out. Hence, a major scientific challenge in this field is to discover and validate alternative tools that will fill the knowledge gap created by the lack of participation in gold-standard randomized trials. This review focuses on novel tools that allow estimation of fetal risks after exposure to therapeutic agents, such as placental perfusion studies, biomarkers of fetal exposure, and novel epidemiological and pharmacogenetic tools, all of which have been tested successfully in recent years.
authors.affiliation: The Motherisk Program, Division of Clinical Pharmacology and Toxicology, Department of Pediatrics, Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada M5G 1X8; email: gideon.koren@sickkids.ca.
authors.forename: Fatma
authors.initials: F
authors.lastname: Etwel
authors.forename: Janine R
authors.initials: JR
authors.lastname: Hutson
authors.forename: Parvaz
authors.initials: P
authors.lastname: Madadi
authors.forename: Joey
authors.initials: J
authors.lastname: Gareri
authors.forename: Gideon
authors.initials: G
authors.lastname: Koren
mesh_terms: D015415:Biomarkers / Q000097:blood*; D001942:Breast Feeding; D015340:Epidemiologic Research Design; D005260:Female; D005333:Fetus / Q000187:drug effects* / Q000378:metabolism; D006801:Humans; D033261:Maternal-Fetal Relations; D015201:Meta-Analysis as Topic; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000097:blood; D010597:Pharmacogenetics; D010920:Placenta / Q000187:drug effects / Q000378:metabolism; D011247:Pregnancy; D011297:Prenatal Exposure Delayed Effects; D012307:Risk Factors
chemical_list: D015415:Biomarkers; D004364:Pharmaceutical Preparations