Module 4

Module 4: Nonclinical Study Reports

Module 4 contains nonclinical study reports organized per ICH M4S: pharmacology (primary, secondary, safety), pharmacokinetics (ADME), and toxicology (general, genetic, carcinogenicity, reproductive).

Sections

4.2.1 — Pharmacology

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

4 sub

4.2.2 — Pharmacokinetics

Pharmacokinetics studies: analytical methods, ADME, PK drug interactions

7 sub

4.2.3.1 — Single-Dose Toxicity

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

4.2.3.2 — Repeat-Dose Toxicity

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

4.2.3.3 — Genotoxicity

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

2 sub

4.2.3.4 — Carcinogenicity

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

3 sub

4.2.3.5 — Reproductive and Developmental Toxicity

Reproductive and developmental toxicity studies: fertility, EFD, pre/postnatal, juvenile

4 sub

4.2.3.6 — Local Tolerance

Local tolerance assessment relevant to route of administration

4.2.3.7 — Other Toxicity Studies

Other toxicity studies: antigenicity, immunotoxicity, mechanistic, dependence, metabolites, impurities, phototoxicity

7 sub

Related Sections

m1 — Module 1: Administrative Information and Prescribing Information

Module 1 contains documents that are specific to each region. It includes administrative information such as application forms, prescribing information, and labeling. This module is NOT part of the Common Technical Document (CTD) and varies by regulatory region.

m2 — Module 2: Common Technical Document Summaries

Module 2 provides overviews and summaries of Modules 3, 4, and 5. It includes the Quality Overall Summary, Nonclinical Overview, Clinical Overview, and detailed written/tabulated summaries.

m3 — Module 3: Quality

Module 3 contains the Body of Data for drug substance (S) and drug product (P) quality information, including manufacturing, controls, characterization, and stability per ICH M4Q guidelines.

m5 — Module 5: Clinical Study Reports

Module 5 contains clinical study reports organized per ICH M4E: biopharmaceutic studies, human PK/PD studies, efficacy and safety studies, post-marketing data, and case report forms.

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