title: Highlights from the United States Food and Drug Administration's public workshop on the development of animal models of pregnancy to address medical countermeasures in an "at-risk" population of pregnant women: Influenza as a case study.
abstract: The U.S. Food and Drug Administration (FDA) and other federal agencies partner to ensure that medical countermeasures (e.g., drug therapies and vaccines) are available for public health emergencies (FDA, 2014). Despite continuing progress, providing medical countermeasures and treatment guidelines for certain populations (e.g., pregnant women) is challenging due to the lack of clinical and/or animal data. Thus, a workshop was convened to discuss animal models of pregnancy for the evaluation of disease progression and medical countermeasures.
authors.affiliation: Division of Biochemical Toxicology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, Arkansas; Huntingdon Life Sciences, Inc., Somerset, New Jersey.
authors.forename: Denita
authors.initials: D
authors.lastname: Williams
authors.forename: Mallikarjuna S
authors.initials: MS
authors.lastname: Basavarajappa
authors.forename: Sonja A
authors.initials: SA
authors.lastname: Rasmussen
authors.forename: Suzanne
authors.initials: S
authors.lastname: Morris
authors.forename: Donald
authors.initials: D
authors.lastname: Mattison
mesh_terms: D000818:Animals; D004195:Disease Models, Animal; D018450:Disease Progression; D004493:Education / Q000379:methods*; D005260:Female; D006801:Humans; D007251:Influenza, Human / Q000188:drug therapy*; D051379:Mice; D010599:Pharmacokinetics; D011247:Pregnancy / Q000502:physiology*; D014481:United States; D014486:United States Food and Drug Administration
keywords: animal models; influenza; medical countermeasures; oseltamivir carboxylate; oseltamivir phosphate; pregnancy