Module 3 - Strategic case studies in practice

MODULE 1 - ADMINISTRATIVE INFORMATION AND PRESCRIBING INFORMATION

CTD

EU CTD (NTA, Vol. 2B, Edition 2006)

NTA, Vol. 2B (Edition 1998)

NTA

Additional Data

Additional Data

MODULE 2 - COMMON TECHNICAL DOCUMENT SUMMARIES

CTD

EU CTD (NTA, Vol. 2B, Edition 2001)

NTA, Vol. 2B (Edition 1998)

NTA

2.1 2.2 2.3

Overall CTD Table of Contents of Modules 2, 3, 4, and 5 Table of Contents for remainder of the dossier

I.A I.C

Introduction

Product profile

Quality Overall Summary

Expert report on the chemical, pharmaceutical and biological documentation Expert Report on the toxico-pharmacological documentation Expert Report on the Clinical Documentation Appendices to the toxico-pharmacological Expert Report

I C 1

2.4

Non-clinical Overview

I C 2

2.5 2.6

Clinical Overview

I C 3 I C 2

Non-clinical Summary

2.6.1 2.6.2 2.6.3 2.6.4 2.6.5 2.6.6

Pharmacology Written Summary Pharmacology Tabulated Summary Pharmacokinetics Written Summary Pharmacokinetics Tabulated Summary Toxicology Written Summary Toxicology Tabulated Summary

Written Summary Tabular Formats Written Summary Tabular Formats

I C 2 I C 2 I C 2 I C 2 I C 2 I C 3 I C 3 I C 3 I C 3 I C 3 I C 3 ---

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Tabular Formats

2.7

Clinical Summary

Appendices to the clinical Expert Report

2.7.1

Summary of biopharmaceutics and associated analytical methods Summary of clinical pharmacology studies

Written Summary

2.7.2 2.7.3 2.7.4 2.7.5

Written Summary Written Summary Written Summary Tabular Formats

Summary of clinical efficacy Summary of clinical safety Synopses of Individual Studies

MODULE 3 – QUALITY

CTD

EU CTD (NTA, Vol. 2B, Edition 2001)

NTA, Vol. 2B (Edition 1998)

NTA

3.1 3.2

MODULE 3 TABLE OF CONTENTS

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BODY OF DATA

Chemical, Pharmaceutical, Biological Documentation II

3.2.S DRUG SUBSTANCE 3.2.S.1 General Information

Scientific Data

II C 1.2

3.2.S.1.1 3.2.S.1.2 3.2.S.1.3

Nomenclature

Nomenclature

II C 1.2.1 II C 1.2.2 II C 1.2.5 II C 1.2.3

Structure

Description: Structural formula Physico-chemical characterization

General Properties

3.2.S.2

Manufacture

Manufacture

3.2.S.2.1 3.2.S.2.2

Manufacturer(s)

Name(s) address(es) of the manufacturing source(s) II C 1.2.3

Description of manufacturing process and process controls

Synthetic or manufacturing route Description of process Quality control during manufacture Quality control during manufacture

II C 1.2.3

3.2.S.2.3 3.2.S.2.4 3.2.S.2.5 3.2.S.2.6

Control of materials

II C 1.2.4 II C 1.2.4

Controls of critical steps and intermediates

Process validation and/or evaluation Manufacturing process development

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3.2.S.3

Characterisation

3.2.S.3.1 3.2.S.3.2

Elucidation of structure and other characteristics

Development chemistry

II C 1.2.5 II C 1.2.6

Impurities

Impurities

3.2.S.4

Control of drug substance

Specifications and routine tests

II C 1.1 II C 1.1 II C 1.1

3.2.S.4.1 3.2.S.4.2

Specification

Specifications and routine tests Specifications and routine tests

Analytical Procedures

NTA, Vol. 2B-CTD, foreword & introduction, edition June 2006

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