Table of Contents Author Guidelines Submit a Manuscript
Advances in Preventive Medicine
Volume 2012, Article ID 507571, 11 pages
http://dx.doi.org/10.1155/2012/507571
Review Article

FDA Experience with Medical Countermeasures under the Animal Rule

Global Regulatory Affairs, Quintiles, Inc., 1801 Rockville Pike, Rockville, MD 20852, USA

Received 4 May 2011; Revised 14 July 2011; Accepted 21 July 2011

Academic Editor: Kelly T. McKee

Copyright © 2012 Paul Aebersold. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Citations to this Article [36 citations]

The following is the list of published articles that have cited the current article.

  • J. P. A. Ioannidis, “Extrapolating from Animals to Humans,” Science Translational Medicine, vol. 4, no. 151, pp. 151ps15–151ps15, 2012. View at Publisher · View at Google Scholar
  • Connie S. Schmaljohn, Leonard A. Smith, and Arthur M. Friedlander, “Military vaccines in today's environment,” Human Vaccines & Immunotherapeutics, vol. 8, no. 8, pp. 1126–1128, 2012. View at Publisher · View at Google Scholar
  • Christopher C. Broder, Thomas W. Geisbert, Kai Xu, Dimitar B. Nikolov, Lin-Fa Wang, Deborah Middleton, Jackie Pallister, Katharine N. Bossart, Christopher C. Broder, Thomas W. Geisbert, Kai Xu, Dimitar B. Nikolov, Lin-Fa Wang, Deborah Middleton, Jackie Pallister, and Katharine N. Bossart, “Immunization Strategies Against Henipaviruses,” Henipavirus: Ecology, Molecular Virology, and Pathogenesis, vol. 359, pp. 197–223, 2012. View at Publisher · View at Google Scholar
  • Thomas P. Monath, “Vaccines against diseases transmitted from animals to humans: A one health paradigm,” Vaccine, 2013. View at Publisher · View at Google Scholar
  • M. Shannon Keckler, Mary G. Reynolds, Inger K. Damon, and Kevin L. Karem, “The effects of post-exposure smallpox vaccination on clinical disease presentation: Addressing the data gaps between historical epidemiology and modern surrogate model data,” Vaccine, 2013. View at Publisher · View at Google Scholar
  • Janet M. Leeds, Frederique Fenneteau, Nathalie H. Gosselin, Mohamad-Samer Mouksassi, Nastya Kassir, J. F. Marier, Yali Chen, Doug Grosenbach, Annie E. Frimm, Kady M. Honeychurch, Jarasvech Chinsangaram, Shanthakumar R. Tyavanagimatt, Dennis E. Hruby, and Robert Jordan, “Pharmacokinetic and Pharmacodynamic Modeling To Determine the Dose of ST-246 To Protect against Smallpox in Humans,” Antimicrobial Agents And Chemotherapy, vol. 57, no. 3, pp. 1136–1143, 2013. View at Publisher · View at Google Scholar
  • Elie Dolgin, “Animal rule for drug approval creates a jungle of confusion,” Nature Medicine, vol. 19, no. 2, pp. 118–119, 2013. View at Publisher · View at Google Scholar
  • Feng Gao, Brian L. Fish, John E. Moulder, Elizabeth R. Jacobs, and Meetha Medhora, “Enalapril Mitigates Radiation-Induced Pneumonitis and Pulmonary Fibrosis if Started 35 Days after Whole-Thorax Irradiation,” Radiation Research, vol. 180, no. 5, pp. 546–552, 2013. View at Publisher · View at Google Scholar
  • Luke SP Moore, Misha Moore, and Shiranee Sriskandan, “Ebola and other viral haemorrhagic fevers: a local operational approach,” British Journal of Hospital Medicine, vol. 75, no. 9, pp. 515–522, 2014. View at Publisher · View at Google Scholar
  • Diana F Florescu, and Megan A Keck, “Development of CMX001 (Brincidofovir) for the treatment of serious diseases or conditions caused by dsDNA viruses,” Expert Review of Anti-infective Therapy, pp. 1–8, 2014. View at Publisher · View at Google Scholar
  • Edna F. R. Pereira, Yasco Aracava, Louis J. DeTolla, E. Jeffrey Beecham, G. William Basinger, Edgar J. Wakayama, and Edson X. Albuquerque, “Animal Models That Best Reproduce the Clinical Manifestations of Human Intoxication with Organophosphorus Compounds,” Journal of Pharmacology and Experimental Therapeutics, vol. 350, no. 2, pp. 313–321, 2014. View at Publisher · View at Google Scholar
  • John E. Moulder, “2013 Dade W. Moeller Lecture,” Health Physics, vol. 107, no. 2, pp. 164–171, 2014. View at Publisher · View at Google Scholar
  • Arik Eisenkraft, and Avshalom Falk, “Toxic Inhalation Injury: Management and Medical Treatment,” Inhalation Toxicology, Third Edition, pp. 357–422, 2014. View at Publisher · View at Google Scholar
  • Stefan Elbe, Anne Roemer-Mahler, and Christopher Long, “Medical Countermeasures for National Security: A New Government Role in the Pharmaceuticalization of Society,” Social Science & Medicine, 2014. View at Publisher · View at Google Scholar
  • Joshua D. Powell, Becky M. Hess, Janine R. Hutchison, and Timothy M. Straub, “Construction of an in vitro primary lung co-culture platform derived from New Zealand white rabbits,” In Vitro Cellular & Developmental Biology - Animal, 2014. View at Publisher · View at Google Scholar
  • Isabel L. Jackson, Pu-ting Xu, Giao Nguyen, Julian D. Down, Cynthia S. Johnson, Barry P. Katz, Caroline C. Hadley, and Zeljko Vujaskovic, “Characterization Of The Dose Response Relationship For Lung Injury Following Acute Radiation Exposure In Three Well-Established Murine Strains: Develo,” Health Physics, vol. 106, no. 1, pp. 48–55, 2014. View at Publisher · View at Google Scholar
  • Eric P. Cohen, Brian L. Fish, John D. Imig, and John E. Moulder, “Mitigation of normal tissue radiation injury: evidence from rat radiation nephropathy models,” Journal of Radiation Oncology, 2015. View at Publisher · View at Google Scholar
  • Reed F. Johnson, Dima A. Hammoud, Matthew G. Lackemeyer, Srikanth Yellayi, Jeffrey Solomon, Jordan K. Bohannon, Krisztina B. Janosko, Catherine Jett, Kurt Cooper, Joseph E. Blaney, and Peter B. Jahrling, “Small particle aerosol inoculation of cowpox Brighton Red in rhesus monkeys results in a severe respiratory disease,” Virology, vol. 481, pp. 124–135, 2015. View at Publisher · View at Google Scholar
  • Vijay K. Singh, Patricia L.P. Romaine, and Thomas M. Seed, “Medical Countermeasures for Radiation Exposure and Related Injuries,” Health Physics, vol. 108, no. 6, pp. 607–630, 2015. View at Publisher · View at Google Scholar
  • J. Kyle Bohannon, Matthew G. Lackemeyer, Jens H. Kuhn, Jiro Wada, Laura Bollinger, Peter B. Jahrling, and Reed F. Johnson, “Generation and characterization of large-particle aerosols using a center flow tangential aerosol generator with a non-human-primate, head-only aerosol chamber,” Inhalation Toxicology, pp. 1–7, 2015. View at Publisher · View at Google Scholar
  • James E Huckle, Matthew P Sadgrove, Russell J Mumper, and Michael Jay, “Species-dependent chelation of (241)Am by DTPA Di-ethyl ester.,” Health physics, vol. 108, no. 4, pp. 443–50, 2015. View at Publisher · View at Google Scholar
  • Rumiko Shimazawa, and Masayuki Ikeda, “Development Of Drug-Approval Regulations For Medical Countermeasures Against Cbrn Agents In Japan,” Health Security, vol. 13, no. 2, pp. 130–138, 2015. View at Publisher · View at Google Scholar
  • Vijay K Singh, Victoria L Newman, Allison N Berg, and Thomas J MacVittie, “Animal models for acute radiation syndrome drug discovery,” Expert Opinion on Drug Discovery, pp. 1–21, 2015. View at Publisher · View at Google Scholar
  • Gopala Krishna, and Saryu Goel, “Alternative Animal Toxicity Testing of Chemical Warfare Agents,” Handbook of Toxicology of Chemical Warfare Agents, pp. 657–673, 2015. View at Publisher · View at Google Scholar
  • Vijay K. Singh, Patricia L.P. Romaine, Victoria L. Newman, and Thomas M. Seed, “Medical countermeasures for unwanted CBRN exposures: part II radiological and nuclear threats with review of recent countermeasure patents,” Expert Opinion on Therapeutic Patents, pp. 1–10, 2016. View at Publisher · View at Google Scholar
  • Vijay K. Singh, Melissa Garcia, Stephen Y. Wise, and Thomas M. Seed, “Medical countermeasures for unwanted CBRN exposures: Part I chemical and biological threats with review of recent countermeasure patents,” Expert Opinion on Therapeutic Patents, pp. 1–17, 2016. View at Publisher · View at Google Scholar
  • Philip J. Sayre, Ian N. Moore, Katie R. Hagen, Kurt Cooper, Dima A. Hammoud, Peter B. Jahrling, Jeffrey Solomon, Jordan K. Bohannon, Catherine Jett, Reed F. Johnson, Amy B. Papaneri, Mahnaz Minai, Joseph E. Blaney, Matthew G. Lackemeyer, Krisztina B. Janosko, and Donna L. Perry, “Exposure of rhesus monkeys to cowpox virus Brighton Red by large-particle aerosol droplets results in an upper respiratory tract disease,” Journal of General Virology, vol. 97, no. 8, pp. 1942–1954, 2016. View at Publisher · View at Google Scholar
  • Vijay Singh, and Martin Hauer-Jensen, “γ-Tocotrienol as a Promising Countermeasure for Acute Radiation Syndrome: Current Status,” International Journal of Molecular Sciences, vol. 17, no. 5, pp. 663, 2016. View at Publisher · View at Google Scholar
  • Kelly L. Warfield, and M. Javad Aman, “Role of small biotechnology companies in the fledgling biodefense vaccine industry,” Expert Review of Vaccines, pp. 1–4, 2016. View at Publisher · View at Google Scholar
  • J. Kyle Bohannon, Anna N. Honko, Rebecca J. Reeder, Kurt Cooper, Russ Byrum, Laura Bollinger, Jens H. Kuhn, Jiro Wada, Jing Qin, Peter B. Jahrling, and Matthew G. Lackemeyer, “Comparison of respiratory inductive plethysmography versus head-out plethysmography for anesthetized nonhuman primates in an animal biosafety level 4 facility,” Inhalation Toxicology, pp. 1–7, 2016. View at Publisher · View at Google Scholar
  • A. R. Satvik Iyengar, and Abhay H. Pande, “Organophosphate-Hydrolyzing Enzymes as First-Line of Defence Against Nerve Agent-Poisoning: Perspectives and the Road Ahead,” The Protein Journal, 2016. View at Publisher · View at Google Scholar
  • Naofumi Bunya, Keigo Sawamoto, Hanif Benoit, and Steven B. Bird, “The Effect of Parathion on Red Blood Cell Acetylcholinesterase in the Wistar Rat,” Journal of Toxicology, vol. 2016, pp. 1–5, 2016. View at Publisher · View at Google Scholar
  • Vijay K. Singh, and Thomas M. Seed, “A review of radiation countermeasures focusing on injury-specific medicinals and regulatory approval status: part I. Radiation sub-syndromes, animal models and FDA-approved countermeasures,” International Journal of Radiation Biology, pp. 1–19, 2017. View at Publisher · View at Google Scholar
  • Janet M. Daly, “Middle East respiratory syndrome (MERS) coronavirus: Putting one health principles into practice?,” The Veterinary Journal, 2017. View at Publisher · View at Google Scholar
  • Brian L. Fish, Thomas J. MacVittie, Aniko Szabo, John E. Moulder, and Meetha Medhora, “WAG/RijCmcr rat models for injuries to multiple organs by single high dose ionizing radiation: similarities to nonhuman primates (NHP),” International Journal of Radiation Biology, pp. 1–12, 2018. View at Publisher · View at Google Scholar
  • Elizabeth A. McCart, Young H. Lee, Jyoti Jha, Ognoon Mungunsukh, W. Bradley Rittase, Thomas A. Summers, Jeannie Muir, and Regina M. Day, “Delayed Captopril Administration Mitigates Hematopoietic Injury in a Murine Model of Total Body Irradiation,” Scientific Reports, vol. 9, no. 1, 2019. View at Publisher · View at Google Scholar