Module 3 - Strategic case studies in practice

MODULE 4 - NONCLINICAL STUDY REPORTS

CTD

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

NTA, Vol. 2B (Edition 1998)

NTA

4.1 4.2

MODULE 4 TABLE OF CONTENTS

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--- III

STUDY REPORTS

TOXICO-PHARMACOLOGICAL DOCUMENTATION

4.2.1

PHARMACOLOGY

PHARMACODYNAMICS

III F

4.2.1.1

Primary pharmacodynamics

Pharmacodynamics effects relating to the proposed indications

III F 1

4.2.1.2 4.2.1.3 4.2.1.4

Secondary pharmacodynamics

General pharmacodynamics General pharmacodynamics

III F 2 III F 2 III F 3

Safety pharmacology

Pharmacodynamic drug interactions

Drug interactions

4.2.2

PHARMACOKINETICS

PHARMACOKINETICS

III G III Q

4.2.2.1 4.2.2.2

Analytical Methods and Validation Reports

Other Information

Absorption

Pharmacokinetics after a single dose Pharmacokinetics after repeated administration Distribution in normal and pregnant animals

III G 1 III G 2 III G 3 III G 4

4.2.2.3 4.2.2.4 4.2.2.5 4.2.2.6 4.2.2.7 4.2.3.1 4.2.3.2 4.2.3.3 4.2.3.4 4.2.3.5 4.2.3

Distribution Metabolism

Biotransformation Pharmacokinetics

Excretion

III G 1, 2

Pharmacokinetic Drug Interactions (nonclinical)

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Other Pharmacokinetic Studies

TOXICOLOGY

TOXICITY

III A

Single-dose toxicity Repeat-dose toxicity

Single dose toxicity studies Repeated dose toxicity studies

III A 1 III A 2

Genotoxicity

Mutagenic Potential Carcinogenic Potential

III D III E III B III C III H III Q III Q

Carcinogenicity

Reproductive Function Embryo-foetal and Perinatal Toxicity

Reproductive and developmental toxicity

4.2.3.6 4.2.3.7

Local tolerance

Local Tolerance Other Information

Other toxicity studies

4.3

LITERATURE REFERENCES

OTHER INFORMATION

MODULE 5- CLINICAL STUDY REPORTS

CTD

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

NTA, Vol. 2B (Edition 1998)

NTA

5.1 5.2

MODULE 5 TABLE OF CONTENTS

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TABULAR LISTINGS OF ALL CLINICAL STUDIES

EXPERT REPORT ON THE CLINICAL DOCUMENTATION, APPENDIX 2: WRITTEN SUMMARY – TABULAR OVERVIEW

I C 3

5.3

CLINICAL STUDY REPORTS

CLINICAL DOCUMENTATION

IV

5.3.1 5.3.2

Reports of Biopharmaceutic Studies

Pharmacokinetics Pharmacokinetics

IV A 2 IV A 2

Reports of Studies Pertinent to Pharmacokinetics using Human Biomaterials Reports of human pharmacokinetic (PK) studies Reports of human pharmacodynamic (PD) studies

5.3.3 5.3.4 5.3.5 5.3.6 5.3.7

Pharmacokinetics Pharmacodynamics

IV A 2 IV A 1 IV B 1 IV B 2 IV B 1

Reports of efficacy and safety studies Reports of post-marketing experience

Clinical Trials

Post-marketing experience (if available) Appendix to each clinical study report, when submitted (Appendix 16.3) PUBLISHED AND UNPUBLISHED EXPERIENCE (OTHER THAN 1) OTHER INFORMATION

Case report forms and individual patient listings, when submitted

5.4

LITERATURE REFERENCES

IV B 3

IV Q

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

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