An FDA/CDER Perspective on Nonclinical Testing Strategies

Avila, A. M., Bebenek, I., Bonzo, J. A., Bourcier, T., Davis Bruno, K. L., Carlson, D. B., Dubinion, J., et al. (2020). An FDA/CDER Perspective on Nonclinical Testing Strategies: Classical Toxicology Approaches and New Approach Methodologies (NAMs). Regulatory Toxicology and Pharmacology.

Type

Journal article

Intellectual base

Primary research

Year

2020

DOI

10.1016/j.yrtph.2020.104662

Link

https://doi.org/10.1016/j.yrtph.2020.104662

Cited by

1 citation across 1 artifact.

Domain-specific

• Adverse Event Prediction
  • … findings, pharmacokinetics, toxicokinetics, prior compounds, disease biology, genetics, literature, and limited early clinical data—into an explicit, uncertainty-bearing forecast that can guide compound selection, first-in-human exposure, monitoring, eligibility, dose escalation, stopping rules, or further studies.

Verification

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Registry ID ref:5e2c740c1582 · see in the full table