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Authors = Shruti V. Kabadi

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7 pages, 453 KiB  
Communication
Considerations for Applying Route-to-Route Extrapolation to Assess the Safety of Oral Exposure to Substances
by Shruti V. Kabadi, Jeffrey Fisher, Benjamin Hung and Jason Aungst
Biomolecules 2023, 13(1), 5; https://doi.org/10.3390/biom13010005 - 20 Dec 2022
Viewed by 2035
Abstract
The safety evaluation of oral exposure to substances, such as food ingredients, additives, and their constituents, relies primarily on a careful evaluation and analysis of data from oral toxicity studies. When relevant oral toxicity studies are unavailable or may have significant data gaps [...] Read more.
The safety evaluation of oral exposure to substances, such as food ingredients, additives, and their constituents, relies primarily on a careful evaluation and analysis of data from oral toxicity studies. When relevant oral toxicity studies are unavailable or may have significant data gaps that make them inadequate for use in safety evaluations, data from non-oral toxicity studies in animals, such as studies on inhalation, dermal exposure, etc., might be used in support of or in place of oral toxicity studies through route-to-route (R-t-R) extrapolation. R-t-R extrapolation is applied on a case-by-case basis as it requires attention to and comparison of substance-specific toxicokinetic (TK) and toxicodynamic (TD) data for oral and non-oral exposure routes. This article provides a commentary on the utility of R-t-R extrapolation to assess the safety of oral exposure to substances, with an emphasis on the relevance of TK and systemic toxicity data. Full article
(This article belongs to the Special Issue Pharmacokinetics, Pharmacodynamics, and Toxicology of Small-Molecule Drugs and Nanomedicine)
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38 pages, 1950 KiB  
Review
IVIVE: Facilitating the Use of In Vitro Toxicity Data in Risk Assessment and Decision Making
by Xiaoqing Chang, Yu-Mei Tan, David G. Allen, Shannon Bell, Paul C. Brown, Lauren Browning, Patricia Ceger, Jeffery Gearhart, Pertti J. Hakkinen, Shruti V. Kabadi, Nicole C. Kleinstreuer, Annie Lumen, Joanna Matheson, Alicia Paini, Heather A. Pangburn, Elijah J. Petersen, Emily N. Reinke, Alexandre J. S. Ribeiro, Nisha Sipes, Lisa M. Sweeney, John F. Wambaugh, Ronald Wange, Barbara A. Wetmore and Moiz Mumtazadd Show full author list remove Hide full author list
Toxics 2022, 10(5), 232; https://doi.org/10.3390/toxics10050232 - 1 May 2022
Cited by 75 | Viewed by 16073
Abstract
During the past few decades, the science of toxicology has been undergoing a transformation from observational to predictive science. New approach methodologies (NAMs), including in vitro assays, in silico models, read-across, and in vitro to in vivo extrapolation (IVIVE), are being developed to [...] Read more.
During the past few decades, the science of toxicology has been undergoing a transformation from observational to predictive science. New approach methodologies (NAMs), including in vitro assays, in silico models, read-across, and in vitro to in vivo extrapolation (IVIVE), are being developed to reduce, refine, or replace whole animal testing, encouraging the judicious use of time and resources. Some of these methods have advanced past the exploratory research stage and are beginning to gain acceptance for the risk assessment of chemicals. A review of the recent literature reveals a burst of IVIVE publications over the past decade. In this review, we propose operational definitions for IVIVE, present literature examples for several common toxicity endpoints, and highlight their implications in decision-making processes across various federal agencies, as well as international organizations, including those in the European Union (EU). The current challenges and future needs are also summarized for IVIVE. In addition to refining and reducing the number of animals in traditional toxicity testing protocols and being used for prioritizing chemical testing, the goal to use IVIVE to facilitate the replacement of animal models can be achieved through their continued evolution and development, including a strategic plan to qualify IVIVE methods for regulatory acceptance. Full article
(This article belongs to the Special Issue Computational Toxicology: Expanding Frontiers in Risk Assessment)
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21 pages, 234 KiB  
Review
Neuroprotective Strategies for Traumatic Brain Injury: Improving Clinical Translation
by Shruti V. Kabadi and Alan I. Faden
Int. J. Mol. Sci. 2014, 15(1), 1216-1236; https://doi.org/10.3390/ijms15011216 - 17 Jan 2014
Cited by 147 | Viewed by 12133
Abstract
Traumatic brain injury (TBI) induces secondary biochemical changes that contribute to delayed neuroinflammation, neuronal cell death, and neurological dysfunction. Attenuating such secondary injury has provided the conceptual basis for neuroprotective treatments. Despite strong experimental data, more than 30 clinical trials of neuroprotection in [...] Read more.
Traumatic brain injury (TBI) induces secondary biochemical changes that contribute to delayed neuroinflammation, neuronal cell death, and neurological dysfunction. Attenuating such secondary injury has provided the conceptual basis for neuroprotective treatments. Despite strong experimental data, more than 30 clinical trials of neuroprotection in TBI patients have failed. In part, these failures likely reflect methodological differences between the clinical and animal studies, as well as inadequate pre-clinical evaluation and/or trial design problems. However, recent changes in experimental approach and advances in clinical trial methodology have raised the potential for successful clinical translation. Here we critically analyze the current limitations and translational opportunities for developing successful neuroprotective therapies for TBI. Full article
(This article belongs to the Special Issue Neuroprotective Strategies 2014)
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