Module 4nonclinicalpharmacologyndaind● Low priority
4.2.1.4 — PD Drug Interactions
Nonclinical studies evaluating pharmacodynamic drug-drug interactions
Requirements by Phase
Phase 1
optional
Phase 2
optional
Phase 3
optional
NDA
optional
Nonclinical studies evaluating pharmacodynamic drug-drug interactions
Requirements by Phase
IND Phase 1: optional IND Phase 2: optional IND Phase 3: optional NDA: optional
Content Requirements
- Summary of PD drug interaction studies if performed
- In vitro and in vivo PD interaction assessments
- Evaluation of additive, synergistic, or antagonistic effects with co-medications
Expected Deliverables
- Study report per ICH E3 format (if performed)
ICH Guidelines: M3(R2)
Source: ICH M3(R2)
References
Related Sections
Up to4.2.1 — Pharmacology4.2.1.1 — Primary Pharmacodynamics
In vitro and in vivo studies evaluating primary pharmacodynamic effects of the drug on its intended target
4.2.1.2 — Secondary Pharmacodynamics
Studies evaluating pharmacological effects on targets other than the intended therapeutic target
4.2.1.3 — Safety Pharmacology
Core battery studies: cardiovascular (hERG + in vivo), CNS (Irwin/FOB), respiratory function
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