Animal Models: A Non-human Primate and Rodent Animal Model Research Platform, Natural History, and Biomarkers to Predict Clinical Outcome

MacVittie, Thomas J.; Farese, Ann M.; Kane, Maureen A.

doi:10.1097/hp.0000000000001479

Cited by 1 publication

(1 citation statement)

References 55 publications

(60 reference statements)

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“…During this time, rodent and NHP models of H-and GI-ARS have been developed (12,23,55). In addition, animal models for DEARE continue to be developed for GI and lung injury (56)(57)(58)(59). Rat and canine models have also been established to test radionuclide decorporation agents (60)(61)(62)(63).…”

Section: Development Of Therapeutics For Radiological and Nuclear Eme...mentioning

confidence: 99%

NIH Policies and Regulatory Pathways to U.S. FDA licensure: Strategies to Inform Advancement of Radiation Medical Countermeasures and Biodosimetry Devices

et al. 2022

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The Radiation and Nuclear Countermeasures Program within the National Institute of Allergy and Infectious Diseases (NIAID), is tasked with the mandate of identifying biodosimetry tests to assess exposure and medical countermeasures (MCMs) to mitigate/treat injuries to individuals exposed to significant doses of ionizing radiation from a radiological/nuclear incident, hosted. To fulfill this mandate, the Radiation and Nuclear Countermeasures Program (RNCP), hosted a workshop in 2018 workshop entitled “Policies and Regulatory Pathways to U.S. FDA licensure: Radiation Countermeasures and Biodosimetry Devices.” The purpose of the meeting was to facilitate the advancement of MCMs and biodosimetry devices by assessing the research devices and animal models used in preclinical studies; government policies on reproducibility, rigor and robustness; regulatory considerations for MCMs and biodosimetry devices; and lessons learned from sponsors of early stage MCM or biodosimetry devices. Meeting presentations were followed by a NIAID-led, open discussion among academic investigators, industry researchers and U.S. government representatives.

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Section: Development Of Therapeutics For Radiological and Nuclear Eme...mentioning

confidence: 99%

NIH Policies and Regulatory Pathways to U.S. FDA licensure: Strategies to Inform Advancement of Radiation Medical Countermeasures and Biodosimetry Devices

et al. 2022

View full text Add to dashboard Cite

show abstract

Animal Models: A Non-human Primate and Rodent Animal Model Research Platform, Natural History, and Biomarkers to Predict Clinical Outcome

Cited by 1 publication

References 55 publications

NIH Policies and Regulatory Pathways to U.S. FDA licensure: Strategies to Inform Advancement of Radiation Medical Countermeasures and Biodosimetry Devices

NIH Policies and Regulatory Pathways to U.S. FDA licensure: Strategies to Inform Advancement of Radiation Medical Countermeasures and Biodosimetry Devices

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