Scratching The Surface Of Nonclinical Dermal Testing

Dermal toxicology studies assess how a compound affects people or animals when it comes into contact with their skin, looking for both local and systemic reactions. This information is crucial for regulatory agencies like the U.S. Food and Drug Administration (FDA) and others around the world when a new drug is submitted for approval.

While the FDA requires this data, it doesn't specify a single method for conducting nonclinical dermal toxicity studies. This flexibility allows scientists to design studies that are best suited for their specific compound, ensuring they gather the most relevant information.

Dermal studies present unique challenges not seen in other types of drug studies, such as those involving oral or injectable administration. The skin itself is a major entry point for chemicals, and factors like the natural variation in skin structure and the risk of animals grooming themselves and ingesting the compound can complicate results. Because of these challenges, no single method or species is sufficient for thoroughly evaluating dermal toxicity.

A solid understanding of the available options for dermal studies, along with their pros and cons, can streamline the drug development process. This not only helps reduce costs but also accelerates the timeline for regulatory approval, getting the compound into clinical trials faster.