Publications by authors named "Jill Merrill"
Purpose: OptiSafe is an test method that identifies potential eye irritants based on macromolecular damage following test chemical exposure. The OptiSafe protocol includes a prescreen assessment that identifies test chemicals that are outside the applicability domain of the test method and thus determines the optimal procedure. We assessed the usefulness and limitations of the OptiSafe test method for identifying chemicals not requiring classification for ocular irritation (i.
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- * While traditional methods are effective at predicting clinical outcomes, there's a push for improved methodologies, especially with the advent of New Approach Methodologies (NAMs) that are being increasingly integrated into drug development.
- * The FDA/CDER acknowledges both the opportunities and challenges that NAMs bring to regulatory processes and encourages dialogue with stakeholders to enhance testing methods and potentially speed up drug development.
Purpose: Eye and skin irritation test data are required or considered by chemical regulation authorities in the United States to develop product hazard labelling and/or to assess risks for exposure to skin- and eye-irritating chemicals. The combination of animal welfare concerns and interest in implementing methods with greater human relevance has led to the development of non-animal skin- and eye-irritation test methods. To identify opportunities for regulatory uses of non-animal replacements for skin and eye irritation tests, the needs and uses for these types of test data at U.
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