References
- Beach T, Authier S, Javitz HS, et al. Total body irradiation models in NHPs – consideration of animal sex and provision of supportive care to advance model development. Int J Radiat Biol. 2021;97(2):126–130. DOI:10.1080/09553002.2021.1844335
- Singh VK, Seed TM. 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. Int J Radiat Biol. 2017;93(9):851–869. DOI:10.1080/09553002.2017.1332438
- Champlin RE, Kastenberg WE, Gale RP. Radiation accidents and nuclear energy: medical consequences and therapy. Ann Intern Med. 1988;109(9):730–744.
- U.S. Food and Drug Administration. Animal Rule information. 2022. Available at: http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMRegulatoryScience/ucm391604.htm [Last accessed Oct 20, 2022]
- U.S. Food and Drug Administration. Animal Rule approvals. 2022. Available at: https://www.fda.gov/drugs/nda-and-bla-approvals/animal-rule-approvals [Last accessed December 5, 2022] There is a list of all drugs approved by US FDA following Animal Rule.
- U.S. Food and Drug Administration. Guidance document: product development under the Animal Rule. 2015. Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm399217.pdf [Last accessed Oct 20, 2022]
- Singh VK, Olabisi AO. Nonhuman primates as models for the discovery and development of radiation countermeasures. Expert Opin Drug Discov. 2017;12(7):695–709. DOI:10.1080/17460441.2017.1323863
- Dorr H, Lamkowski A, Graessle DH, et al. Linking the human response to unplanned radiation and treatment to the nonhuman primate response to controlled radiation and treatment. Health Phys. 2014;106:129–134.
- Garg S, Garg TK, Miousse IR, et al. Effects of gamma-tocotrienol on partial-body irradiation-induced intestinal injury in a nonhuman primate model. Antioxidants (Basel). 2022;11:1895.
- Garg S, Garg TK, Wise SY, et al. Effects of gamma-tocotrienol on intestinal injury in a GI-specific acute radiation syndrome model in nonhuman primate. Int J Mol Sci. 2022;23:4643.
- Garg TK, Garg S, Miousse IR, et al. Gamma-tocotrienol modulates total-body irradiation-induced hematopoietic injury in a nonhuman primate model. Int J Mol Sci. 2022;23:16170.
- Williams JP, Brown SL, Georges GE, et al. Animal models for medical countermeasures to radiation exposure. Radiat Res. 2010;173:557–578. DOI:10.1667/RR1880.1
- Farese AM, Cohen MV, Katz BP, et al. Filgrastim improves survival in lethally irradiated nonhuman primates. Radiat Res. 2013;179:89–100.
- Hankey KG, Farese AM, Blaauw EC, et al. Pegfilgrastim improves survival of lethally irradiated nonhuman primates. Radiat Res. 2015;183:643–655.
- Wong K, Bunin DI, Bujold K, et al. Romiplostim (Nplate) alone and in combination with pegfilgrastim (Neulasta) increased survival and reduces incidence, duration, and severity of thrombocytopenia post-irradiation in non-human primates. 66th Annual Conference of Radiation Research Society. Virtual https://www.radres.org/events/EventDetails.aspx?id=1336280 2020
- Wong K, Chang PY, Fielden M, et al. Pharmacodynamics of romiplostim alone and in combination with pegfilgrastim on acute radiation-induced thrombocytopenia and neutropenia in non-human primates. Int J Radiat Biol. 2020;96:155–166.
- Clayton NP, Khan-Malek RC, Dangler CA, et al. Sargramostim (rhu GM-CSF) improves survival of non-human primates with severe bone marrow suppression after acute, high-dose, whole-body irradiation. Radiat Res. 2021;195:191–199.
- Zhong Y, Pouliot M, Downey AM, et al. Efficacy of delayed administration of sargramostim up to 120 hours post exposure in a nonhuman primate total body radiation model. Int J Radiat Biol. 2021;97:S100–16.
- Singh VK, Seed TM. An update on sargramostim for treatment of acute radiation syndrome. Drugs Today (Barc). 2018;54:679–693.
- Singh VK, Seed TM. An update on romiplostim for treatment of acute radiation syndrome. Drugs Today (Barc). 2022;58:133–145.
- MacVittie TJ, Farese AM, Parker GA, et al. The time course of radiation-induced lung injury in a nonhuman primate model of partial-body irradiation with minimal bone marrow sparing: clinical and radiographic evidence and the effect of neupogen administration. Health Phys. 2019;116:366–382.
- Singh VK, Seed TM. Radiation countermeasures for hematopoietic acute radiation syndrome: growth factors, cytokines and beyond. Int J Radiat Biol. 2021;97:1526–1547.
- Singh VK, Fatanmi OO, Wise SY, et al. Determination of lethality curve for cobalt-60 gamma-radiation source in rhesus macaques using subject-based supportive care. Radiat Res. 2022;198:599–614.
- Singh VK, Kulkarni S, Fatanmi OO, et al. Radioprotective efficacy of gamma-tocotrienol in nonhuman primates. Radiat Res. 2016;185:285–298.
- National Research Council of the National Academy of Sciences. Guide for the care and use of laboratory animals. 8th ed. (WA) DC: National Academies Press; 2011.
- Vellichirammal NN, Sethi S, Pandey S, et al. Lung transcriptome of nonhuman primates exposed to total- and partial-body irradiation. Mol Ther Nucleic Acids. 2022;29:584–598.
- Cheema AK, Li Y, Moulton J, et al. Identification of novel biomarkers for acute radiation injury using multiomics approach and nonhuman primate model. Int J Radiat Oncol Biol Phys. 2022;114:310–320.
- Li Y, Singh J, Varghese R, et al. Transcriptome of rhesus macaque (Macaca mulatta) exposed to total-body irradiation. Sci Rep. 2021;11:6295.
- Carpenter AD, Li Y, Janocha BL, et al. Analysis of the proteomic profile in serum of irradiated nonhuman primates treated with Ex-Rad, a radiation medical countermeasure. J Proteome Res. 2023;22:116.
- Kulkarni S, Singh PK, Ghosh SP, et al. Granulocyte colony-stimulating factor antibody abrogates radioprotective efficacy of gamma-tocotrienol, a promising radiation countermeasure. Cytokine. 2013;62:278–285.
- American Veterinary Medical Association. AVMA Guidelines for the Euthanasia of Animals: 2020 Edition. 2020. Available at: https://www.avma.org/sites/default/files/2020-01/2020-Euthanasia-Final-1-17-20.pdf [Last accessed Dec 29, 2022]
- Phipps AJ, Bergmann JN, Albrecht MT, et al. Model for evaluating antimicrobial therapy to prevent life-threatening bacterial infections following exposure to a medically significant radiation dose. Antimicrob Agents Chemother. 2022;66:e0054622.
- Snoy PJ. Establishing efficacy of human products using animals: the US food and drug administration’s “animal rule”. Vet Pathol. 2010;47:774–778.
- Aebersold P. FDA experience with medical countermeasures under the Animal Rule. Adv Prevent Med. 2012;2012:507571.
- Park GD, Mitchel JT. Working with the U.S. Food and Drug Administration to obtain approval of products under the Animal Rule. Ann N Y Acad Sci. 2016;1374:10–16.
- Orschell CM, Wu T, Patterson AM. Impact of age, sex, and genetic diversity in murine models of the hematopoietic acute radiation syndrome (H-ARS) and the delayed effects of acute radiation exposure (DEARE). Current Stem Cell Reports. 2022;8:139–149.
- Patterson AM, Vemula S, Plett PA, et al. Age and sex divergence in hematopoietic radiosensitivity in aged mouse models of the hematopoietic acute radiation syndrome. Radiat Res. 2022;198:221–242.
- Kiang JG, Cannon G, Olson MG, et al. Female mice are more resistant to the mixed-field (67% neutron + 33% gamma) radiation-induced injury in bone marrow and small intestine than male mice due to sustained increases in G-CSF and the Bcl-2/Bax ratio and lower miR-34a and MAPK activation. Radiat Res. 2022;198:120–133.
- Singh VK, Seed TM. Development of gamma-tocotrienol as a radiation medical countermeasure for the acute radiation syndrome: current status and future perspectives. Expert Opin Investig Drugs. 2023;32:25–35.
- Rosen E, Fatanmi OO, Wise SY, et al. Gamma-tocotrienol, a radiation countermeasure, reverses proteomic changes in serum following total-body gamma irradiation in mice. Sci Rep. 2022;12:3387.
- Pannkuk EL, Laiakis EC, Fornace AJ Jr., et al. A metabolomic serum signature from nonhuman primates treated with a radiation countermeasure, gamma-tocotrienol, and exposed to ionizing radiation. Health Phys. 2018;115:3–11.
- Cheema, AK, Mehta KY, Fatanmi OO, et al. A Metabolomic and lipidomic serum signature from nonhuman primates administered with a promising radiation countermeasure, gamma-tocotrienol Int J Mol Sci 2017;19:79