Module 4nonclinicalpharmacologyndaind

4.2.1 — Pharmacology

Pharmacology studies: primary PD, secondary PD, safety pharmacology, PD drug interactions

Phase 1

required

Phase 2

required

Phase 3

required

NDA

required

Pharmacology studies: primary PD, secondary PD, safety pharmacology, PD drug interactions

IND Phase 1: required IND Phase 2: required IND Phase 3: required NDA: required

Source: ICH M3(R2); ICH S7A

References

In vitro and in vivo studies evaluating primary pharmacodynamic effects of the drug on its intended target

Studies evaluating pharmacological effects on targets other than the intended therapeutic target

Core battery studies: cardiovascular (hERG + in vivo), CNS (Irwin/FOB), respiratory function

Nonclinical studies evaluating pharmacodynamic drug-drug interactions

Pharmacokinetics studies: analytical methods, ADME, PK drug interactions

Acute toxicity studies in 2 species (rodent and non-rodent) to determine lethal dose and target organ toxicity

Repeat-dose toxicity studies with duration matching or exceeding planned clinical exposure. ICH M3(R2) Table 1 defines minimum durations.

Genotoxicity studies: in vitro (Ames, chromosomal aberration) and in vivo (micronucleus)

Carcinogenicity studies: long-term bioassay, short-term transgenic models, other studies

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