Module 4-nonclinical

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).

Module 4 is the preclinical data — pharmacology, pharmacokinetics, and toxicology study reports. This is Regfo's core focus. Every study report you upload gets checked against ICH M3(R2), S7A, S2(R1), and 20+ other guidelines.

The sections you'll spend the most time on: Safety Pharmacology (cardiovascular, CNS, respiratory — the core battery), Repeat-Dose Toxicity (duration must match your clinical plan), and Genotoxicity (three-test battery, five Ames strains, specific concentration limits).

Upload your Module 4 study reports to Regfo and get a compliance score with specific gap citations in under 30 seconds.

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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