new drug application (nda)

What Challenges Are Faced in Toxicological Evaluations?

Several challenges can arise in toxicological evaluations:
- Animal to Human Extrapolation: One of the main challenges is extrapolating data from animal studies to humans. Differences in physiology and metabolism can lead to variations in drug effects.
- Complexity of Biological Systems: The complexity of biological systems makes it difficult to predict all potential toxic effects, especially those that may occur at low doses or over long durations.
- Emerging Technologies: Advances in technology and understanding of biomarkers can both improve and complicate toxicological evaluations. While they offer more detailed insights, they also increase the complexity of data interpretation.

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