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Preclinical Toxicology/Safety Considerations in the Development of Ophthalmic Drugs and Devices
Published in David W. Hobson, Dermal and Ocular Toxicology, 2020
Robert B. Hackett, Michael E. Stern
CDRH is aware of the ongoing research efforts to achieve the goal of eventual substitution of in vitro tests for certain biological tests utilizing animals. Cell culture methods using corneal epithelial, stromal, and endothelial cell lines are currently being researched as in vitro alternatives to the Draize test for identification of ocular irritants and for use in cytotoxicity evaluation. Another method being considered as an alternative is the chorioallantoic membrane (CAM) assay. The CAM assay is based on the fact that the CAM has anatomical components that are similar to the structure of the eye and reacts to insults with inflammatory responses. However, at present, in vitro alternatives to animal testing have not been sufficiently developed or validated for use. Therefore, CDRH regrets that toxicology tests involving animals must continue to be used at this time in order to adequately assess risks and evaluate safety of ocular products prior to approval for general marketing. CDRH will continue to monitor the developments of alternatives to animal testing and will encourage their use once such studies have been validated.
Approaches to Safety Evaluation of Botanicals and Processed Botanicals Known in Traditional Knowledge
Published in Dilip Ghosh, Pulok K. Mukherjee, Natural Medicines, 2019
D.B. Anantha Narayana, Sharanbasappa Durg
Even in those cases where processes are modified that appear to be different from the traditional processes, a number of innovative approaches are being developed by scientists in the assessment of safety of botanicals. The primary objective is to give weightage to long history of use and to avoid unnecessary conventional toxicology data generation that is time consuming, expensive and complicated. The pressure of environmentalists and animal enthusiasts is also forcing the reduction in testing involving animals and leading to the development of alternatives to animal testing. In fact, testing of any ingredient – including botanicals – on animals for safety data for use in any cosmetic preparation has already been prohibited (European Commission 2016).
3D models as tools for inhaled drug development
Published in Anthony J. Hickey, Heidi M. Mansour, Inhalation Aerosols, 2019
Sally-Ann Cryan, Jennifer Lorigan, Cian O’Leary
In vitro cell-based methods are at present primarily used for scientific screening purposes and to support in vivo animal data in regulatory dossier submissions. Key to the incorporation of more advanced 3D models into standardized scientific and industrial development programmes and further to their acceptance by the regulatory agencies will be robust validation of their reproducibility, sensitivity, availability and predictive abilities. Many of the novel 3D models emerging are still early in this validation process, and focus must in the first instance be on standardizing the methods; key after that is selection of an appropriate model against which to validate. There are agencies now which support this kind of validation work, for example, the European Union Reference Laboratory for Alternatives to animal testing (EURL-ECVAM). For human cell-based 3D models, validation against the current gold-standard animal model might not be most relevant, while ex vivo models, for example, EVLP model or lung slices, can perhaps offer better tools to compare drug/formulation effects.
Characterizing the effects of titanium dioxide and silver nanoparticles released from painted surfaces due to weathering on zebrafish (Danio rerio)
Published in Nanotoxicology, 2021
Krittika Mittal, Arshath Abdul Rahim, Saji George, Subhasis Ghoshal, Niladri Basu
In recent years, there have been calls to improve the relevancy of ecotoxicity studies in terms of environmental plausibility, biological realism, and regulatory connection (Staveley and Wentsel 2016; Rudén et al. 2017). For ENPs in particular, there is a need for studies that better reflect realistic exposure scenarios (Holden et al. 2016; Selck et al. 2016), and thus a need for studies that evaluate weathered ENPs at environmental concentrations. Additionally, there is also a push to replace traditional whole animal tests with alternatives to animal testing strategies such as in vitro and early life stage (embryo) methods, and to better characterize perturbations at the molecular level rather than characterizing apical endpoints such as growth and survival (NRC 2007). For aquatic models, there are established cell lines such as the zebrafish liver cell line (Bols et al. 2005; Chen et al. 2011), and standardization of the fish embryotoxicity test (FET) by the Organization for Economic Co-operation and Development (OECD; test guideline 236) has facilitated their use in aquatic toxicity studies. Developing a testing system using these alternative methods for ENPs released from painted surfaces could serve to speed up the testing process while providing a more in-depth understanding of their toxic effects.
United States regulatory requirements for skin and eye irritation testing
Published in Cutaneous and Ocular Toxicology, 2019
Neepa Y. Choksi, James Truax, Adrienne Layton, Joanna Matheson, David Mattie, Timothy Varney, Jenny Tao, Krystle Yozzo, Andrew J. McDougal, Jill Merrill, Donnie Lowther, Joao Barroso, Brenda Linke, Warren Casey, David Allen
Important to the discussion of alternatives to animal testing is not only whether an alternative approach exists, but also whether the alternative approaches are being used by industry and accepted by government agencies. This understanding is critical to determine the best course of action to reduce animal use. A common theme across U.S. agencies is the willingness to consider alternatives and the recommendation for sponsors to consult directly with the relevant agency in designing their testing program. Communication is clearly essential to ensure that transparency is maintained in defining expectations from both industry and government agencies. National validation organizations (e.g. NICEATM, EURL ECVAM, the Japanese Center for the Validation of Alternative Methods, and the Korean Center for the Validation of Alternative Methods) and relevant non-governmental organizations could provide an important contribution in promoting existing alternative approaches to interested stakeholders.
Use of proteomics to detect sex-related differences in effects of toxicants: implications for using proteomics in toxicology
Published in Critical Reviews in Toxicology, 2018
Ivonne M. C. M. Rietjens, Jacques Vervoort, Anna Maslowska-Górnicz, Nico Van den Brink, Karsten Beekmann
Proteome analysis promises the discovery of novel biomarkers and biomarker patterns of health effects induced by diseases, drugs and dietary interventions, and may be equally useful in the field of toxicology. The method may even contribute to the development of alternatives for animal testing when studying modes of action, biomarkers of human exposure and/or defining safe levels of human exposure. Given that there are well defined differences in the composition of the proteome in males and females (Geyer et al. 2016) the technique may also allow the detection of sex-based differences in response to toxicants. The present review provides an overview of the current state-of-the-art of the use of proteome analysis in detecting and understanding sex-based differences in response and sensitivity to toxicants as an example of using proteomics in toxicological research.