IND Applications for Clinical Investigations

U.S. Food and Drug Administration. IND Applications for Clinical Investigations: Pharmacology and Toxicology Information.

Type

Web resource

Intellectual base

Web

Link

https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-applications-clinical-investigations-pharmacology-and-toxicology-pt-information

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

This reference passed the adversarial substantiation pipeline: it was checked to exist and to support the claim it is attached to. See how references were verified.

Registry ID ref:10449c7167c9 · see in the full table