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The future of dermatological safety: FDA’s new approach to predicting dermal sensitisation

Traditional methods for evaluating the immunotoxic potential of pharmaceuticals typically involve animal testing, which is time-consuming, costly, and raises ethical concerns. In response to these challenges, regulatory agencies, including the Food and Drug Administration (FDA), are actively encouraging the development and acceptance of alternative methods.

FDA’s new guidance on dermal sensitisation

The FDA has recently issued an important guidance titled “Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals”, which introduces a novel approach to predicting human skin sensitisation for topical pharmaceuticals through a battery of studies, including in silico, in chemico, and in vitro methods. The FDA’s adoption of these alternative methods signifies a paradigm shift towards more efficient assessments, reducing the reliance on animal testing.

Topical pharmaceuticals are medications that are applied to the surface of the body, usually in the form of creams, ointments, gels, lotions, or patches. As of June 2023, the FDA will consider a battery of studies (e.g., in silico, in chemico, in vitro) to assess the dermal sensitisation potential of active ingredients within topical pharmaceuticals. Scientific research and studies have shown that a combination of non-animal testing methods can adequately predict human skin sensitisation with an accuracy resembling existing in vivo methods.

The new guidance states that topical pharmaceuticals should be assessed for their dermal sensitisation potential; an immune response to a previously encountered chemical or substance that results in an inflammatory/allergic dermal reaction upon repeated exposure. One way to predict skin sensitisation hazard and potency is through combining in silico, in chemico and in vitro data, known as defined approaches, which are described in the OECD Guideline No.497 on Defined Approaches for Skin Sensitisation. One of the three approved defined approaches mentioned within the guideline, ITSv1 by Kao corporation, includes Lhasa’s in silico expert knowledge tool Derek Nexus as a required information source to predict skin sensitisation potential using structural alerts.

What are the benefits of this new approach?

The adoption of this battery of alternative methods brings several advantages to both the pharmaceutical industry and regulatory authorities. Firstly, it promotes the use of new approach methodologies, reducing the reliance on animal testing. Secondly, the use of in silico, in chemico, and in vitro methods allows for early identification of potential skin sensitizers, enabling companies to prioritize and optimize compounds based on their immunotoxicity profile. This early assessment can significantly reduce late-stage failures and associated costs, leading to more efficient drug development.

The release of this revolutionary guidance by the FDA marks a significant milestone in the transition towards alternative methods for assessing skin sensitisation. The integration of in silico, in chemico, and in vitro approaches provides a comprehensive battery of tests that can predict the dermal sensitisation of topical pharmaceuticals in a more efficient and ethical manner.

How can our tools help?

Discover how you can incorporate in silico tools into your skin sensitisation assessments, and as an alternative to animal testing on our skin sensitisation page.

If you would like more information on how our tools can help to assess the dermal sensitisation of topical pharmaceuticals, please get in touch.

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