M3(R2): Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

International Council for Harmonisation. (2009). M3(R2): Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.

Type

Book chapter

Intellectual base

Review or monograph

Year

2009

Link

https://database.ich.org/sites/default/files/M3_R2__Guideline.pdf

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.

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