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1 Administrative Information and Prescribing Information
2 Common Technical Document Summaries

2.2 Introduction
2.3 Quality Overall Summary

2.3 Introduction
2.3.S Drug Substance
2.3.P Drug Product
2.3.A Appendices
2.3.R Regional Information

2.4 Nonclinical Overview
2.5 Clinical Overview
2.6 Nonclinical Written and Tabulated Summaries

2.6.1 Introduction
2.6.2 Pharmacology Written Summary
2.6.3 Pharmacology Tabulated Summary
2.6.4 Pharmacokinetics Written Summary
2.6.5 Pharmacokinetics Tabulated Summary
2.6.6 Toxicology Written Summary
2.6.7 Toxicology Tabulated Summary

2.7 Clinical Summary

2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods
2.7.2 Summary of Clinical Pharmacology Studies
2.7.3 Summary of Clinical Efficacy - Indication
2.7.4 Summary of Clinical Safety
2.7.5 Literature References
2.7.6 Synopses of Individual Studies

3 Quality

3.2 Body of Data

3.2.S Drug Substance

3.2.S Drug Substance - substance-1 - manufacturer-1

3.2.S.1 General Information

3.2.S.1.1 Nomenclature
3.2.S.1.2 Structure
3.2.S.1.3 General Properties

3.2.S.2 Manufacture

3.2.S.2.1 Manufacturer(s)
3.2.S.2.2 Description of Manufacturing Process and Process Controls
3.2.S.2.3 Control of Materials
3.2.S.2.4 Controls of Critical Steps and Intermediates
3.2.S.2.5 Process Validation and/or Evaluation
3.2.S.2.6 Manufacturing Process Development

3.2.S.3 Characterisation

3.2.S.3.1 Elucidation of Structure and Other Characteristics
3.2.S.3.2 Impurities

3.2.S.4 Control of Drug Substance

3.2.S.4.1 Specification
3.2.S.4.2 Analytical Procedures

3.2.S.4.2.1 Analytical Procedure-1
3.2.S.4.2.2 Analytical Procedure-2
3.2.S.4.2.3 Analytical Procedure-3

3.2.S.4.3 Validation of Analytical Procedures

3.2.S.4.3.1 Validation of Analytical Procedure-1
3.2.S.4.3.2 Validation of Analytical Procedure-2
3.2.S.4.3.3 Validation of Analytical Procedure-3

3.2.S.4.4 Batch Analyses
3.2.S.4.5 Justification of Specification

3.2.S.5 Reference Standards or Materials
3.2.S.6 Container Closure System
3.2.S.7 Stability

3.2.S.7.1 Stability Summary and Conclusions
3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment
3.2.S.7.3 Stability Data

3.2.P Drug Product

3.2.P Drug Product - product-1

3.2.P.1 Description and Composition of the Drug Product
3.2.P.2 Pharmaceutical Development
3.2.P.3 Manufacture

3.2.P.3.1 Manufacturer(s)
3.2.P.3.2 Batch Formula
3.2.P.3.3 Description of Manufacturing Process and Process Controls
3.2.P.3.4 Controls of Critical Steps and Intermediates
3.2.P.3.5 Process Validation and/or Evaluation

3.2.P.4 Control of Excipients

3.2.P.4 Control of Excipients - excipient-1

3.2.P.4.1 Specifications
3.2.P.4.2 Analytical Procedures
3.2.P.4.3 Validation of Analytical Procedures
3.2.P.4.4 Justification of Specifications
3.2.P.4.5 Excipients of Human or Animal Origin
3.2.P.4.6 Novel Excipients

3.2.P.5 Control of Drug Product

3.2.P.5.1 Specification(s)
3.2.P.5.2 Analytical Procedures

3.2.P.5.2.1 Analytical Procedure - 1
3.2.P.5.2.2 Analytical Procedure - 2
3.2.P.5.2.3 Analytical Procedure - 3

3.2.P.5.3 Validation of Analytical Procedures

3.2.P.5.3.1 Validation of Analytical Procedures - 1
3.2.P.5.3.2 Validation of Analytical Procedures - 2
3.2.P.5.3.3 Validation of Analytical Procedures - 3

3.2.P.5.4 Batch Analyses
3.2.P.5.5 Characterisation of Impurities
3.2.P.5.6 Justification of Specifications

3.2.P.6 Reference Standards or Materials
3.2.P.7 Container Closure System
3.2.P.8 Stability

3.2.P.8.1 Stability Summary and Conclusion
3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment
3.2.P.8.3 Stability Data

3.2.A Appendices

3.2.A.1 Facilities and Equipment

3.2.A.1.1 Facilities and Equipment Report 1
3.2.A.1.2 Facilities and Equipment Report 2
3.2.A.1.3 Facilities and Equipment Report 3

3.2.A.2 Adventitious Agents Safety Evaluation

3.2.A.2.1 Adventitious Agents Safety Evaluation Report 1
3.2.A.2.2 Adventitious Agents Safety Evaluation Report 2
3.2.A.2.3 Adventitious Agents Safety Evaluation Report 3

3.2.A.3 Excipients - excip-name-1

3.2.R Regional Information

3.3 Literature References

3.3.1 Reference 1
3.3.2 Reference 2
3.3.3 Reference 3

4 Nonclinical Study Reports

4.2 Study Reports

4.2.1 Pharmacology

4.2.1.1 Primary Pharmacodynamics

4.2.1.1.1 Study Report 1
4.2.1.1.2 Study Report 2
4.2.1.1.3 Study Report 3

4.2.1.2 Secondary Pharmacodynamics

4.2.1.2.1 Study Report 1
4.2.1.2.2 Study Report 2
4.2.1.2.3 Study Report 3

4.2.1.3 Safety Pharmacology

4.2.1.3.1 Study Report 1
4.2.1.3.2 Study Report 2
4.2.1.3.3 Study Report 3

4.2.1.4 Pharmacodynamic Drug Interactions

4.2.1.4.1 Study Report 1
4.2.1.4.2 Study Report 2
4.2.1.4.3 Study Report 3

4.2.2 Pharmacokinetics

4.2.2.1 Analytical Methods and Validation Reports

4.2.2.1.1 Study Report 1
4.2.2.1.2 Study Report 2
4.2.2.1.3 Study Report 3

4.2.2.2 Absorption

4.2.2.2.1 Study Report 1
4.2.2.2.2 Study Report 2
4.2.2.2.3 Study Report 3

4.2.2.3 Distribution

4.2.2.3.1 Study Report 1
4.2.2.3.2 Study Report 2
4.2.2.3.3 Study Report 3

4.2.2.4 Metabolism

4.2.2.4.1 Study Report 1
4.2.2.4.2 Study Report 2
4.2.2.4.3 Study Report 3

4.2.2.5 Excretion

4.2.2.5.1 Study Report 1
4.2.2.5.2 Study Report 2
4.2.2.5.3 Study Report 3

4.2.2.6 Pharmacokinetic Drug Interactions

4.2.2.6.1 Study Report 1
4.2.2.6.2 Study Report 2
4.2.2.6.3 Study Report 3

4.2.2.7 Other Pharmacokinetic Studies

4.2.2.7.1 Study Report 1
4.2.2.7.2 Study Report 2
4.2.2.7.3 Study Report 3

4.2.3 Toxicology

4.2.3.1 Single-Dose Toxicity

4.2.3.1.1 Study Report 1
4.2.3.1.2 Study Report 2
4.2.3.1.3 Study Report 3

4.2.3.2 Repeat-Dose Toxicity

4.2.3.2.1 Study Report 1
4.2.3.2.2 Study Report 2
4.2.3.2.3 Study Report 3

4.2.3.3 Genotoxicity

4.2.3.3.1 In vitro

4.2.3.3.1.1 Study Report 1
4.2.3.3.1.2 Study Report 2
4.2.3.3.1.3 Study Report 3

4.2.3.3.2 In vivo

4.2.3.3.2.1 Study Report 1
4.2.3.3.2.2 Study Report 2
4.2.3.3.2.3 Study Report 3

4.2.3.4 Carcinogenicity

4.2.3.4.1 Long-term studies

4.2.3.4.1.1 Study Report 1
4.2.3.4.1.2 Study Report 2
4.2.3.4.1.3 Study Report 3

4.2.3.4.2 Short- or medium-term studies

4.2.3.4.2.1 Study Report 1
4.2.3.4.2.2 Study Report 2
4.2.3.4.2.3 Study Report 3

4.2.3.4.3 Other studies

4.2.3.4.3.1 Study Report 1
4.2.3.4.3.2 Study Report 2
4.2.3.4.3.3 Study Report 3

4.2.3.5 Reproductive and Developmental Toxicity

4.2.3.5.1 Fertility and early embryonic development

4.2.3.5.1.1 Study Report 1
4.2.3.5.1.2 Study Report 2
4.2.3.5.1.3 Study Report 3

4.2.3.5.2 Embryo-fetal development

4.2.3.5.2.1 Study Report 1
4.2.3.5.2.2 Study Report 2
4.2.3.5.2.3 Study Report 3

4.2.3.5.3 Prenatal and postnatal development, including maternal function

4.2.3.5.3.1 Study Report 1
4.2.3.5.3.2 Study Report 2
4.2.3.5.3.3 Study Report 3

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

4.2.3.5.4.1 Study Report 1
4.2.3.5.4.2 Study Report 2
4.2.3.5.4.3 Study Report 3

4.2.3.6 Local Tolerance

4.2.3.6.1 Study Report 1
4.2.3.6.2 Study Report 2
4.2.3.6.3 Study Report 3

4.2.3.7 Other Toxicity Studies

4.2.3.7.1 Antigenicity

4.2.3.7.1.1 Study Report 1
4.2.3.7.1.2 Study Report 2
4.2.3.7.1.3 Study Report 3

4.2.3.7.2 Immunotoxicity

4.2.3.7.2.1 Study Report 1
4.2.3.7.2.2 Study Report 2
4.2.3.7.2.3 Study Report 3

4.2.3.7.3 Mechanistic studies

4.2.3.7.3.1 Study Report 1
4.2.3.7.3.2 Study Report 2
4.2.3.7.3.3 Study Report 3

4.2.3.7.4 Dependence

4.2.3.7.4.1 Study Report 1
4.2.3.7.4.2 Study Report 2
4.2.3.7.4.3 Study Report 3

4.2.3.7.5 Metabolites

4.2.3.7.5.1 Study Report 1
4.2.3.7.5.2 Study Report 2
4.2.3.7.5.3 Study Report 3

4.2.3.7.6 Impurities

4.2.3.7.6.1 Study Report 1
4.2.3.7.6.2 Study Report 2
4.2.3.7.6.3 Study Report 3

4.2.3.7.7 Other

4.2.3.7.7.1 Study Report 1
4.2.3.7.7.2 Study Report 2
4.2.3.7.7.3 Study Report 3

4.3 Literature References

4.3.1 Reference 1
4.3.2 Reference 2
4.3.3 Reference 3

5 Clinical Study Reports

5.2 Tabular Listing of all Clinical Studies
5.3 Clinical Study Reports

5.3.1 Reports of Biopharmaceutic Studies

5.3.1.1 Bioavailability (BA) Study Reports

5.3.1.1.1 Study Report 1
5.3.1.1.2 Study Report 2
5.3.1.1.3 Study Report 3

5.3.1.2 Comparative BA and Bioequivalence (BE) Study Reports

5.3.1.2.1 Study Report 1
5.3.1.2.2 Study Report 2
5.3.1.2.3 Study Report 3

5.3.1.3 In vitro - In vivo Correlation Study Reports

5.3.1.3.1 Study Report 1
5.3.1.3.2 Study Report 2
5.3.1.3.3 Study Report 3

5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human Studies

5.3.1.4.1 Study Report 1
5.3.1.4.2 Study Report 2
5.3.1.4.3 Study Report 3

5.3.2 Reports of Studies Pertinent to Pharmacokinetics using Human Biomaterials

5.3.2.1 Plasma Protein Binding Study Reports

5.3.2.1.1 Study Report 1
5.3.2.1.2 Study Report 2
5.3.2.1.3 Study Report 3

5.3.2.2 Reports of Hepatic Metabolism and Drug Interaction Studies

5.3.2.2.1 Study Report 1
5.3.2.2.2 Study Report 2
5.3.2.2.3 Study Report 3

5.3.2.3 Reports of Studies Using Other Human Biomaterials

5.3.2.3.1 Study Report 1
5.3.2.3.2 Study Report 2
5.3.2.3.3 Study Report 3

5.3.3 Reports of Human Pharmacokinetic (PK) Studies

5.3.3.1 Healthy Subject PK and Initial Tolerability Study Reports

5.3.3.1.1 Study Report 1
5.3.3.1.2 Study Report 2
5.3.3.1.3 Study Report 3

5.3.3.2 Patient PK and Initial Tolerability Study Reports

5.3.3.2.1 Study Report 1
5.3.3.2.2 Study Report 2
5.3.3.2.3 Study Report 3

5.3.3.3 Intrinsic Factor PK Study Reports

5.3.3.3.1 Study Report 1
5.3.3.3.2 Study Report 2
5.3.3.3.3 Study Report 3

5.3.3.4 Extrinsic Factor PK Study Reports

5.3.3.4.1 Study Report 1
5.3.3.4.2 Study Report 2
5.3.3.4.3 Study Report 3

5.3.3.5 Population PK Study Reports

5.3.3.5.1 Study Report 1
5.3.3.5.2 Study Report 2
5.3.3.5.3 Study Report 3

5.3.4 Reports of Human Pharmacodynamic (PD) Studies

5.3.4.1 Healthy Subject PD and PK/PD Study Reports

5.3.4.1.1 Study Report 1
5.3.4.1.2 Study Report 2
5.3.4.1.3 Study Report 3

5.3.4.2 Patient PD and PK/PD Study Reports

5.3.4.2.1 Study Report 1
5.3.4.2.2 Study Report 2
5.3.4.2.3 Study Report 3

5.3.5 Reports of Efficacy and Safety Studies
5.3.5 Reports of Efficacy and Safety Studies - Indication Name

5.3.5.1 Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication

5.3.5.1.1 Study Report 1
5.3.5.1.2 Study Report 2
5.3.5.1.3 Study Report 3

5.3.5.2 Study Reports of Uncontrolled Clinical Studies

5.3.5.2.1 Study Report 1
5.3.5.2.2 Study Report 2
5.3.5.2.3 Study Report 3

5.3.5.3 Reports of Analyses of Data from More than One Study

5.3.5.3.1 Study Report 1
5.3.5.3.2 Study Report 2
5.3.5.3.3 Study Report 3

5.3.5.4 Other Study Reports

5.3.5.4.1 Study Report 1
5.3.5.4.2 Study Report 2
5.3.5.4.3 Study Report 3

5.3.6 Reports of Postmarketing Experience
5.3.7 Case Report Forms and Individual Patient Listings

5.3.7.1 Study 1

5.3.7.1.1 Document/Dataset 1
5.3.7.1.2 Document/Dataset 2
5.3.7.1.3 Document/Dataset 3

5.3.7.2 Study 2

5.3.7.2.1 Document/Dataset 1
5.3.7.2.2 Document/Dataset 2
5.3.7.2.3 Document/Dataset 3

5.3.7.3 Study 3

5.3.7.3.1 Document/Dataset 1
5.3.7.3.2 Document/Dataset 2
5.3.7.3.3 Document/Dataset 3

5.4 Literature References

5.4.1 Reference 1
5.4.2 Reference 2
5.4.3 Reference 3