4.2.1 — Pharmacology
Pharmacology studies: primary PD, secondary PD, safety pharmacology, PD drug interactions
Requirements by Phase
Pharmacology covers how your drug works (primary PD), what else it does (secondary PD), and whether it's safe for major organ systems (safety pharmacology). ICH S7A requires a core battery of three organ system assessments — cardiovascular, CNS, and respiratory — before first-in-human dosing.
The section most teams focus on first: Safety Pharmacology, which includes the hERG assay for cardiac risk. Primary Pharmacodynamics documents your drug's mechanism of action and dose-response. PD Drug Interactions are needed if your drug will be co-administered with other compounds.
References
Sections
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
Related Articles
Related Sections
Up toModule 4: Nonclinical Study ReportsPharmacokinetics 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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