Merle G. Paule, PhDSmartTots Steering Committee Member | Steering Committee, FDA Alternate
Merle G. Paule, PhD
U.S. Food and Drug Administration
Areas of Specialty: Dr. Paule specializes in neuropharmacology/toxicology and developmental neurotoxicology. He has extensive experience conducting cognitive function assessments and pediatric studies in animal models, including non-human primates.
Research Activities: As the FDA’s Director of the Division of Neurotoxicology at the National Center for Toxicological Research (NCTR), Dr. Paule leads research focused on identifying approaches and methods for assessing the neurotoxicity of known or suspected neuroactive chemicals responsible for inducing brain-related disorders. His division facilitates FDA chemical evaluation and regulation, elucidating neurotoxic effects of therapeutic drugs, food additives and products, and other chemical substances. The ultimate goal of this research is to determine ideal dosage levels or conditions at which these chemicals can be used most effectively with minimal adverse side effects, securing the safety of the consumer. Dr. Paule’s division employs multidisciplinary approaches to develop quantitative biomarkers and identify biological pathways associated with neurotoxicity, permitting opportunities for improved risk assessment and the development of novel therapeutics.
National Center for Toxicological Research, U.S. Food and Drug Administration
Paule MG, Li M, Allen RR, Liu F, Zou X, Hotchkiss C, Hanig JP, Patterson TA, Slikker W Jr, Wang C. Ketamine anesthesia during the first week of life can cause long-lasting cognitive deficits in rhesus monkeys. Neurotoxicol Teratol 2011 Jan 15.
Patterson YA, Li M, Hotchkiss CE, Mauz A, Eddie M, Greischel A, Stierstorfer B, Deschl U, Paule MG. Toxicity assessment of pramipexole in juvenile rhesus monkeys. Toxicology 2010;276(3):164-71.
Zou X, Patterson TA, Sadovova N, Twaddle NC, Doerge DR, Zhang X, Fu X, Hanig JP, Paule MG, Slikker W, Wang C. Potential neurotoxicity of ketamine in the developing rat brain. Toxicol Sci 2009;108(1):149-58.
Wang C, Sadovova N, Patterson TA, Zou X, Fu X, Hanig JP, Paule MG, Ali SF, Zhang X, Slikker W. Protective effects of 7-nitroindazole on ketamine-induced neurotoxicity in rat forebrain culture. Neurotoxicology 2008;29(4):613-20.
Zou X, Sadovova N, Patterson TA, Divine RL, Hotchkiss CE, Ali SF, Hanig JP, Paule MG, Slikker W, Wang C. The effects of L-carnitine on the combination of, inhalation anesthetic-induced developmental, neuronal apoptosis in the rat frontal cortex. Neuroscience 2008;151(4):1053-65.
Slikker W, Zou X, Hotchkiss CE, Divine RL, Sadovova N, Twaddle NC, Doerge DR, Scallet AC, Patterson TA, Hanig JP, Paule MG, Wang C. Ketamine-induced neuronal cell death in the perinatal rhesus monkey. Toxicol Sci 2007;98(1):145-58.
Wang C, Sadovova N, Ali HK, Duhart HM, Fu X, Zou X, Patterson TA, Binienda ZK, Virmani A, Paule MG, Slikker W, Ali SF. L-carnitine protects neurons from 1-methyl-4-phenylpyridinium-induced neuronal apoptosis in rat forebrain culture.Neuroscience 2007;144(1):46-55.
Haberny KA, Paule MG, Scallet AC, Sistare FD, Lester DS, Hanig JP, Slikker W.Ontogeny of the N-methyl-D-aspartate (NMDA) receptor system and susceptibility to neurotoxicity. Toxicol Sci 2002;68(1):9-17.
Popke EJ, Patton R, Newport GD, Rushing LG, Fogle CM, Allen RR, Pearson EC, Hammond TG, Paule MG. Assessing the potential toxicity of MK-801 and remacemide: chronic exposure in juvenile rhesus monkeys. Neurotox teratol 2002;24(2):193-207.
Mayorga AJ, Popke EJ, Fogle CM, Paule MG. Similar effects of amphetamine and methylphenidate on the performance of complex operant tasks in rats. Behav Brain Res 2000;109(1):59-68.
Buffalo EA, Gillam MP, Allen RR, Paule MG. Acute behavioral effects of MK-801 in rhesus monkeys: assessment using an operant test battery. Pharmacol Biochem Behav 1994;48(4):935-40.