Division 4.1 Format and PresentationF1

The general outline of Module 4 is as follows:

• Table of contents

• Study reports

  • Pharmacology

    • Primary Pharmaco-dynamics

    • Secondary Pharmaco-dynamics

    • Safety Pharmacology

    • Pharmaco-dynamic Interactions

  • Pharmaco-kinetics

    • Analytical Methods and Validation Reports

    • Absorption

    • Distribution

    • Metabolism

    • Excretion

    • Pharmaco-kinetic Interactions (non-clinical)

    • Other Pharmaco-kinetic Studies

  • Toxicology

    • Single-Dose Toxicity

    • Repeat-Dose Toxicity

    • Genotoxicity

      • In vitro

      • In vivo (including supportive toxico-kinetics evaluations)

    • Carcinogenicity

      • Long-term studies

      • Short- or medium-term studies

      • Other studies

    • Reproductive and Developmental Toxicity

      • Fertility and early embryonic development

      • Embryo-fetal development

      • Prenatal and postnatal development

      • Studies in which the offspring (juvenile animals) are dosed and/or further evaluated

    • Local Tolerance

  • Other Toxicity Studies

    • Antigenicity

    • Immuno-toxicity

    • Mechanistic studies

    • Dependence

    • Metabolites

    • Impurities

    • Other

• Literature references