New Drug Application(NDA)

 

New Drug Application

It is an application filed with FDA, for a U.S. generic drug approval for an existing licensed medication or approved drug. In simple words, ―It is an application for the approval of Generic Drugs.

A New Drug Application (NDA) is a comprehensive submission to the U.S. Food and Drug Administration (FDA) by a drug sponsor seeking approval to market a new drug in the United States. The NDA provides detailed information to the FDA to evaluate the safety, efficacy, labeling, and manufacturing standards of the new drug. It includes data from laboratory and animal preclinical studies as well as human clinical trials (Phase 1-4). The FDA reviews the NDA within 60 days of submission and issues one of three action letters: Approval Letter, Approvable Letter, or Not Approvable Letter

The NDA's goals are to offer adequate material for FDA reviewers to make the following essential decisions:

• Whether the medicine is safe and effective in its intended application(s), and whether the benefits exceed the dangers.
• Determine whether the drug's proposed labeling (package insert) is suitable and what it should include.
• Whether the drug's manufacturing processes and quality control measures are sufficient to maintain the drug's identity, strength, quality, and purity.

The process that the regulatory authorities follow when reviewing a New Drug Application

1. Submission: The pharmaceutical company submits the NDA, which includes detailed information about the drug, such as its composition, manufacturing process, preclinical and clinical data, proposed labeling, and more.

2. Acceptance and Filing: The regulatory authorities review the NDA to ensure it meets the necessary requirements for submission. If accepted, it is "filed," and the review process officially begins.

3. Initial Review: The regulatory authorities conduct an initial review to assess the completeness and quality of the NDA. They evaluate if the data provided justify further review and determine if any additional information is needed.

4. Review Division Assignment: The NDA is assigned to a specific review division within the regulatory authorities based on the therapeutic area or drug class. The assigned reviewers have expertise in the relevant field.

5. Comprehensive Review: The reviewers thoroughly examine all aspects of the NDA, including the drug's safety, efficacy, quality, and manufacturing processes. They analyze preclinical and clinical data, study protocols, adverse events, and any other relevant information.

6. Labeling and Risk Management Plan: The reviewers assess the proposed labeling for accuracy, clarity, and appropriateness. They also examine the Risk Evaluation and Mitigation Strategies (REMS) proposed by the pharmaceutical company to ensure proper risk management.

7. Advisory Committee Evaluation: In some cases, an advisory committee of external experts is convened to provide additional expertise and opinions on the drug's safety and efficacy. Their recommendations are taken into consideration during the review process.

8. Communication and Questions: During the review, the regulatory authorities often communicate with the pharmaceutical company to seek clarification, request additional data, or address any concerns or questions that arise.

9. Decision: Based on the comprehensive review and evaluation, the regulatory authorities make a decision on the NDA. They may approve the drug for marketing, request further studies or information, or issue a complete response letter outlining any deficiencies that need to be addressed.

NDA approval process 

CTD CHECKLIST FOR NDA APPLICATION

Module 1 Regional administrative information        

1.1       Application form       

1.2       Cover letters  

1.3       Administrative information  

1.3.1    Contact/sponsor/applicant information         

1.3.2    Field copy of certification     

1.3.3    Debarment certification        

1.3.4    Financial certification and disclosure

1.3.5    Patent and exclusivity

1.3.5.1 Patent information     

1.3.5.2 Patent certification    

1.3.5.3 Exclusivity claim       

1.3.6    Tropical disease priority reviewer voucher   

Module 2:  COMMON TECHNICAL DOCUMENT SUMMARIES          

2.1       CTD Table of Content           

2.2       Introduction   

2.3       Quality Overall Summary     

2.3.S    Drug Substance ( Name, Manufacture)        

2.3.S.1 General Information (name, manufacturer)  

2.3.S.2 Manufacture (name, manufacturer)  

2.3.S.3 Characterisation (name, manufacturer).        

2.3.S.4 Control of Drug Substance (name, manufacturer)    

2.3.S.5 Reference Standards or Materials (name, manufacturer).    

2.3.S.6 Container Closure System (name, manufacturer)     

2.3.S.7 Stability (name, manufacturer)         

2.3.P    Drug Product ( Name, Dosage Form)

2.3.P.1 Description and Composition of the Drug Product (name, dosage form)    

2.3.P.2 Pharmaceutical Development (name, dosage form) 

2.3.P.3 Manufacture (name, dosage form)    

2.3.P.4 Control of Excipients (name, dosage form)  

2.3.P.5 Control of Drug Product (name, dosage form)         

2.3.P.6 Reference Standards or Materials (name, dosage form)       

2.3.P.7 Container Closure System (name, dosage form)      

2.3.P.8 Stability (name, dosage form)

2.3.A   APPENDICES           

2.3.A.1 Facilities and Equipment (name, manufacturer)       

2.3.A.2 Adventitious Agents Safety Evaluation (name, dosage form, manufacturer)           

2.3.A.3 Excipients      

2.3.R   Regional Information

2.4       Non Clinical Overview          

2.5       Clinical Overview     

2.5.1    Product Development Rationale.      

2.5.2    Overview of Biopharmaceutics        

2.5.3    Overview of Clinical Pharmacology 

2.5.4    Overview of Efficacy

2.5.5    Overview of Safety   

2.5.6    Benefits and Risks Conclusions        

2.5.7    Literature References

2.6       Non clinical written and tabulatd summary  

2.6.1    Introduction   

2.6.2    Pharmacology Written Summary      

2.6.2.1 Brief Summary          

2.6.2.2 Primary Pharmacodynamics 

2.6.2.3 Secondary Pharmacodynamics         

2.6.2.4 Safety Pharmacology

2.6.2.5 Pharmacodynamic Drug Interactions

2.6.2.6 Discussion and Conclusions  

2.6.2.7 Tables and Figures    

2.6.3    Pharmacology Tabulated Summary  

2.6.4    Pharmacokinetics Written Summary

2.6.4.1 Brief Summary          

2.6.4.2 Methods of Analysis 

2.6.4.3 Absorption     

2.6.4.4 Distribution   

2.6.4.5 Metabolism (interspecies comparison)         

2.6.4.6 Excretion       

2.6.4.7 Pharmacokinetic Drug Interactions   

2.6.4.8 Other Pharmacokinetic Studies         

2.6.4.9 Discussion and Conclusions  

2.6.4.10           Tables and Figures    

2.6.5    Pharmacokinetics Tabulated Summary         

2.6.6    Toxicology Written Summary          

2.6.6.1 Brief Summary          

2.6.6.2 Single-Dose Toxicity

2.6.6.3 Repeat-Dose Toxicity (including supportive toxicokinetics evaluation)     

2.6.6.4 Genotoxicity  

2.6.6.5 Carcinogenicity (including supportive toxicokinetics evaluations) .

2.6.6.6 Reproductive and Developmental Toxicity (including range-finding studies and supportive toxicokinetics evaluations)   

2.6.6.7 Local Tolerance         

2.6.6.8 Other Toxicity Studies (if available) 

2.6.6.9 Discussion and Conclusions  

2.6.6.10           Tables and Figures    

2.6.7    Toxicology Tabulated Summary       

2.7       Clinical Summary     

2.7.1    Summary of Biopharmaceutic Studies and Associated Analytical Methods

2.7.1.1 Background and Overview    

2.7.1.2 Summary of Results of Individual Studies   

2.7.1.3 Comparison and Analyses of Results Across Studies           

2.7.1.4 Appendix       

2.7.2    Summary of Clinical Pharmacology Studies

2.7.2.1 Background and Overview    

2.7.2.2 Summary of Results of Individual Studies   

2.7.2.3 Comparison and Analyses of Results Across Studies           

2.7.2.4 Special Studies          

2.7.2.5 Appendix       

2.7.3    Summary of Clinical Efficacy           

2.7.3.1 Background and Overview of Clinical Efficacy       

2.7.3.2 Summary of Results of Individual Studies   

2.7.3.3 Comparison and Analyses of Results Across Studies           

2.7.3.4 Analysis of Clinical Information Relevant to Dosing Recommendations    

2.7.3.5 Persistence of Efficacy and/or Tolerance Effects     

2.7.3.6 Appendix       

2.7.4    Summary of Clinical Safety  

2.7.4.1 Exposure to the Drug 

2.7.4.2 Adverse Events          

2.7.4.3 Clinical Laboratory Evaluations       

2.7.4.4 Vital Signs, Physical Findings, and Other Observations Related to Safety  

2.7.4.5 Safety in Special Groups and Situations       

2.7.4.6 Post-marketing Data  

2.7.4.7 Appendix       

2.7.5    Literature References

2.7.6    Synopses of Individual Studies         

Module 3:  Quality    

3.1       Table of Content        

3.2       Body of Data 

3.2.S    Drug Substance ( Name, Manufacture)        

3.2.S.1 General Information (name, manufacturer)  

3.2.S.1.1          Nomenclature (name, manufacturer)

3.2.S.1.2          Structure (name, manufacturer)        

3.2.S.1.3          General Properties (name, manufacturer)     

3.2.S.2 Manufacture (name, manufacturer)  

3.2.S.2.1          Manufacturer(s) (name, manufacturer          

3.2.S.2.2          Description of Manufacturing Process and Process Controls (name, manufacturer).

3.2.S.2.3          Control of Materials (name, manufacturer)  

3.2.S.2.4          Controls of Critical Steps and Intermediates (name, manufacturer)

3.2.S.2.5          Process Validation and/or Evaluation (name, manufacturer)

3.2.S.2.6          Manufacturing Process Development (name, manufacturer)

3.2.S.3 Characterisation (name, manufacturer)         

3.2.S.3.1          Elucidation of Structure and other Characteristics (name, manufacturer).

3.2.S.3.2          Impurities (name, manufacturer)      

3.2.S.4 Control of Drug Substance (name, manufacturer)    

3.2.S.4.1          Specification (name, manufacturer)  

3.2.S.4.2          Analytical Procedures (name, manufacturer)

3.2.S.4.3          Validation of Analytical Procedures (name, manufacturer) 

3.2.S.4.4          Batch Analyses (name, manufacturer)          

3.2.S.4.5          Justification of Specification (name, manufacturer) 

3.2.S.5 Reference Standards or Materials (name, manufacturer)     

3.2.S.6 Container Closure System (name, manufacturer)     

3.2.S.7 Stability (name, manufacturer)         

3.2.S.7.1          Stability Summary and Conclusions (name, manufacturer) 

3.2.S.7.2          Post-approval Stability Protocol and Stability Commitment (name, manufacturer)

3.2.S.7.3          Stability Data (name, manufacturer) 

3.2.P    Drug Product ( Name, Dosage Form)

3.2.P.1 Description and Composition of the Drug Product (name, dosage form)    

3.2.P.2 Pharmaceutical Development (name, dosage form) 

3.2.P.2.1          Component of drug product (Name, manufacturer) 

3.2.P.2.1.1       Drug Substance (name, dosage form)

3.2.P.2.1.2       Excipients (Name, manufacturer)     

3.2.P.2.2          Drug product (Name, manufacturer)

3.2.P.2.2.1       Formulation development (Name, manufacturer)    

3.2.P.2.2.2       Overages (Name, manufacturer)       

3.2.P.2.2.3       Physiochemical and biological properties (Name, manufacturer)    

3.2.P.2.3          Manufacturing process development (Name, manufacturer)

3.2.P.2.4          Container closure system (Name, manufacturer)     

3.2.P.2.5          Microbiological attributes (Name, manufacturer)    

3.2.P.2.6          Compatibility (Name, manufacturer)

3.2.P.3 Manufacturer (Name, manufacturer)

3.2.P.3.1          Manufacturer (Name, manufacturer)

3.2.P.3.2          Batch formula (Name, manufacturer)

3.2.P.3.3          Description of manufacturing processes and process (Name, manufacturer)

3.2.P.3.4          Control critical steps and intermediate (Name, manufacturer)         

3.2.P.3.5          Process validation and evaluation (Name, manufacturer)    

3.2.P.4 Control of excipients (Name, manufacturer)

3.2.P.4.1          Specification (Name, manufacturer) 

3.2.P.4.2          Analytical procedure (Name, manufacturer)

3.2.P.4.3          Validation of analytical procedure (Name, manufacturer)   

3.2.P.4.4          Justification of specification (Name, manufacturer)

3.2.P.4.5          Excipient of human and animal (Name, manufacturer)        

3.2.P.4.6          Novel excipients (Name, manufacturer)       

3.2.P.5 Control of drug product (Name, manufacturer)        

3.2.P.5.1          Specification (s) (Name, manufacturer)        

3.2.P.5.2          Analytical procedure (Name, manufacturer)

3.2.P.5.3          Validation of analytical procedure (Name, manufacturer)   

3.2.P.5.4          Batch analysis (Name, manufacturer)

3.2.P.5.5          Characterization of impurities (Name, manufacturer)          

3.2.P.5.6          Justification of Specification(s) (name, dosage form)          

3.2.P.6 Reference Standards or Materials (name, dosage form)       

3.2.P.7 Container Closure System (name, dosage form)      

3.2.P.8 Stability (name, dosage form)

3.2.P.8.1          Stability Summary and Conclusion (name, dosage form)    

3.2.P.8.2          Post-approval Stability Protocol and Stability Commitment (name, dosage form) 

3.2.P.8.3          Stability Data (name, dosage form)  

3.2.A   APPENDICES           

3.2.A.1 Facilities and Equipment (name, manufacturer)       

3.2.A.2 Adventitious Agents Safety Evaluation (name, dosage form, manufacturer)           

3.2.A.3 Excipients      

3.2.4    Regional Information

3.3       Literature References

Module 4:  NONCLINICAL STUDY REPORTS     

Module 1 Regional administrative information        

1.1       Application form       

1.2       Cover letters  

1.3       Administrative information  

1.3.1    Contact/sponsor/applicant information         

1.3.2    Field copy of certification     

1.3.3    Debarment certification        

1.3.4    Financial certification and disclosure

1.3.5    Patent and exclusivity

1.3.5.1 Patent information     

1.3.5.2 Patent certification    

1.3.5.3 Exclusivity claim       

1.3.6    Tropical disease priority reviewer voucher   

Module 2:  COMMON TECHNICAL DOCUMENT SUMMARIES          

2.1       CTD Table of Content           

2.2       Introduction   

2.3       Quality Overall Summary     

2.3.S    Drug Substance ( Name, Manufacture)        

2.3.S.1 General Information (name, manufacturer)  

2.3.S.2 Manufacture (name, manufacturer)  

2.3.S.3 Characterisation (name, manufacturer).        

2.3.S.4 Control of Drug Substance (name, manufacturer)    

2.3.S.5 Reference Standards or Materials (name, manufacturer).    

2.3.S.6 Container Closure System (name, manufacturer)     

2.3.S.7 Stability (name, manufacturer)         

2.3.P    Drug Product ( Name, Dosage Form)

2.3.P.1 Description and Composition of the Drug Product (name, dosage form)    

2.3.P.2 Pharmaceutical Development (name, dosage form) 

2.3.P.3 Manufacture (name, dosage form)    

2.3.P.4 Control of Excipients (name, dosage form)  

2.3.P.5 Control of Drug Product (name, dosage form)         

2.3.P.6 Reference Standards or Materials (name, dosage form)       

2.3.P.7 Container Closure System (name, dosage form)      

2.3.P.8 Stability (name, dosage form)

2.3.A   APPENDICES           

2.3.A.1 Facilities and Equipment (name, manufacturer)       

2.3.A.2 Adventitious Agents Safety Evaluation (name, dosage form, manufacturer)           

2.3.A.3 Excipients      

2.3.R   Regional Information

2.4       Non Clinical Overview          

2.5       Clinical Overview     

2.5.1    Product Development Rationale.      

2.5.2    Overview of Biopharmaceutics        

2.5.3    Overview of Clinical Pharmacology 

2.5.4    Overview of Efficacy

2.5.5    Overview of Safety   

2.5.6    Benefits and Risks Conclusions        

2.5.7    Literature References

2.6       Non clinical written and tabulatd summary  

2.6.1    Introduction   

2.6.2    Pharmacology Written Summary      

2.6.2.1 Brief Summary          

2.6.2.2 Primary Pharmacodynamics 

2.6.2.3 Secondary Pharmacodynamics         

2.6.2.4 Safety Pharmacology

2.6.2.5 Pharmacodynamic Drug Interactions

2.6.2.6 Discussion and Conclusions  

2.6.2.7 Tables and Figures    

2.6.3    Pharmacology Tabulated Summary  

2.6.4    Pharmacokinetics Written Summary

2.6.4.1 Brief Summary          

2.6.4.2 Methods of Analysis 

2.6.4.3 Absorption     

2.6.4.4 Distribution   

2.6.4.5 Metabolism (interspecies comparison)         

2.6.4.6 Excretion       

2.6.4.7 Pharmacokinetic Drug Interactions   

2.6.4.8 Other Pharmacokinetic Studies         

2.6.4.9 Discussion and Conclusions  

2.6.4.10           Tables and Figures    

2.6.5    Pharmacokinetics Tabulated Summary         

2.6.6    Toxicology Written Summary          

2.6.6.1 Brief Summary          

2.6.6.2 Single-Dose Toxicity

2.6.6.3 Repeat-Dose Toxicity (including supportive toxicokinetics evaluation)     

2.6.6.4 Genotoxicity  

2.6.6.5 Carcinogenicity (including supportive toxicokinetics evaluations) .

2.6.6.6 Reproductive and Developmental Toxicity (including range-finding studies and supportive toxicokinetics evaluations)   

2.6.6.7 Local Tolerance         

2.6.6.8 Other Toxicity Studies (if available) 

2.6.6.9 Discussion and Conclusions  

2.6.6.10           Tables and Figures    

2.6.7    Toxicology Tabulated Summary       

2.7       Clinical Summary     

2.7.1    Summary of Biopharmaceutic Studies and Associated Analytical Methods

2.7.1.1 Background and Overview    

2.7.1.2 Summary of Results of Individual Studies   

2.7.1.3 Comparison and Analyses of Results Across Studies           

2.7.1.4 Appendix       

2.7.2    Summary of Clinical Pharmacology Studies

2.7.2.1 Background and Overview    

2.7.2.2 Summary of Results of Individual Studies   

2.7.2.3 Comparison and Analyses of Results Across Studies           

2.7.2.4 Special Studies          

2.7.2.5 Appendix       

2.7.3    Summary of Clinical Efficacy           

2.7.3.1 Background and Overview of Clinical Efficacy       

2.7.3.2 Summary of Results of Individual Studies   

2.7.3.3 Comparison and Analyses of Results Across Studies           

2.7.3.4 Analysis of Clinical Information Relevant to Dosing Recommendations    

2.7.3.5 Persistence of Efficacy and/or Tolerance Effects     

2.7.3.6 Appendix       

2.7.4    Summary of Clinical Safety  

2.7.4.1 Exposure to the Drug 

2.7.4.2 Adverse Events          

2.7.4.3 Clinical Laboratory Evaluations       

2.7.4.4 Vital Signs, Physical Findings, and Other Observations Related to Safety  

2.7.4.5 Safety in Special Groups and Situations       

2.7.4.6 Post-marketing Data  

2.7.4.7 Appendix       

2.7.5    Literature References

2.7.6    Synopses of Individual Studies         

Module 3:  Quality    

3.1       Table of Content        

3.2       Body of Data 

3.2.S    Drug Substance ( Name, Manufacture)        

3.2.S.1 General Information (name, manufacturer)  

3.2.S.1.1          Nomenclature (name, manufacturer)

3.2.S.1.2          Structure (name, manufacturer)        

3.2.S.1.3          General Properties (name, manufacturer)     

3.2.S.2 Manufacture (name, manufacturer)  

3.2.S.2.1          Manufacturer(s) (name, manufacturer          

3.2.S.2.2          Description of Manufacturing Process and Process Controls (name, manufacturer).

3.2.S.2.3          Control of Materials (name, manufacturer)  

3.2.S.2.4          Controls of Critical Steps and Intermediates (name, manufacturer)

3.2.S.2.5          Process Validation and/or Evaluation (name, manufacturer)

3.2.S.2.6          Manufacturing Process Development (name, manufacturer)

3.2.S.3 Characterisation (name, manufacturer)         

3.2.S.3.1          Elucidation of Structure and other Characteristics (name, manufacturer).

3.2.S.3.2          Impurities (name, manufacturer)      

3.2.S.4 Control of Drug Substance (name, manufacturer)    

3.2.S.4.1          Specification (name, manufacturer)  

3.2.S.4.2          Analytical Procedures (name, manufacturer)

3.2.S.4.3          Validation of Analytical Procedures (name, manufacturer) 

3.2.S.4.4          Batch Analyses (name, manufacturer)          

3.2.S.4.5          Justification of Specification (name, manufacturer) 

3.2.S.5 Reference Standards or Materials (name, manufacturer)     

3.2.S.6 Container Closure System (name, manufacturer)     

3.2.S.7 Stability (name, manufacturer)         

3.2.S.7.1          Stability Summary and Conclusions (name, manufacturer) 

3.2.S.7.2          Post-approval Stability Protocol and Stability Commitment (name, manufacturer)

3.2.S.7.3          Stability Data (name, manufacturer) 

3.2.P    Drug Product ( Name, Dosage Form)

3.2.P.1 Description and Composition of the Drug Product (name, dosage form)    

3.2.P.2 Pharmaceutical Development (name, dosage form) 

3.2.P.2.1          Component of drug product (Name, manufacturer) 

3.2.P.2.1.1       Drug Substance (name, dosage form)

3.2.P.2.1.2       Excipients (Name, manufacturer)     

3.2.P.2.2          Drug product (Name, manufacturer)

3.2.P.2.2.1       Formulation development (Name, manufacturer)    

3.2.P.2.2.2       Overages (Name, manufacturer)       

3.2.P.2.2.3       Physiochemical and biological properties (Name, manufacturer)    

3.2.P.2.3          Manufacturing process development (Name, manufacturer)

3.2.P.2.4          Container closure system (Name, manufacturer)     

3.2.P.2.5          Microbiological attributes (Name, manufacturer)    

3.2.P.2.6          Compatibility (Name, manufacturer)

3.2.P.3 Manufacturer (Name, manufacturer)

3.2.P.3.1          Manufacturer (Name, manufacturer)

3.2.P.3.2          Batch formula (Name, manufacturer)

3.2.P.3.3          Description of manufacturing processes and process (Name, manufacturer)

3.2.P.3.4          Control critical steps and intermediate (Name, manufacturer)         

3.2.P.3.5          Process validation and evaluation (Name, manufacturer)    

3.2.P.4 Control of excipients (Name, manufacturer)

3.2.P.4.1          Specification (Name, manufacturer) 

3.2.P.4.2          Analytical procedure (Name, manufacturer)

3.2.P.4.3          Validation of analytical procedure (Name, manufacturer)   

3.2.P.4.4          Justification of specification (Name, manufacturer)

3.2.P.4.5          Excipient of human and animal (Name, manufacturer)        

3.2.P.4.6          Novel excipients (Name, manufacturer)       

3.2.P.5 Control of drug product (Name, manufacturer)        

3.2.P.5.1          Specification (s) (Name, manufacturer)        

3.2.P.5.2          Analytical procedure (Name, manufacturer)

3.2.P.5.3          Validation of analytical procedure (Name, manufacturer)   

3.2.P.5.4          Batch analysis (Name, manufacturer)

3.2.P.5.5          Characterization of impurities (Name, manufacturer)          

3.2.P.5.6          Justification of Specification(s) (name, dosage form)          

3.2.P.6 Reference Standards or Materials (name, dosage form)       

3.2.P.7 Container Closure System (name, dosage form)      

3.2.P.8 Stability (name, dosage form)

3.2.P.8.1          Stability Summary and Conclusion (name, dosage form)    

3.2.P.8.2          Post-approval Stability Protocol and Stability Commitment (name, dosage form) 

3.2.P.8.3          Stability Data (name, dosage form)  

3.2.A   APPENDICES           

3.2.A.1 Facilities and Equipment (name, manufacturer)       

3.2.A.2 Adventitious Agents Safety Evaluation (name, dosage form, manufacturer)           

3.2.A.3 Excipients      

3.2.4    Regional Information

3.3       Literature References

Module 4:  NONCLINICAL STUDY REPORTS     

4.1       Table of Contents of Module 4          

4.2       Study Reports

4.2.1    Pharmacology

4.2.1.1 Primary Pharmacodynamics 

4.2.1.2 Secondary Pharmacodynamics         

4.2.1.3 Safety Pharmacology

4.2.1.4 Pharmacodynamic Drug Interactions

4.2.2    Pharmacokinetics      

4.2.2.1 Analytical Methods and Validation Reports (if separate reports are available)           

4.2.2.2 Absorption     

4.2.2.3 Distribution   

4.2.2.4 Metabolism   

4.2.2.5 Excretion       

4.2.2.6 Pharmacokinetic Drug Interaction    

4.2.2.7 Other Pharmacokinetic Studies         

4.2.3    Toxicology    

4.2.3.1 Single-Dose Toxicity (in order by species, by route)

4.2.3.2 Repeat-Dose Toxicity (in order by species, by route, by duration; including supportive toxicokinetics evaluation)

4.2.3.3 Genotoxicity  

4.2.3.4 Carcinogenicity         

4.2.3.5 Reproductive and Developmental Toxicity  

4.2.3.6 Local Tolerance         

4.2.3.7 Other Toxicity Studies (if available) 

4.3       Literature References  

Module 5 : CLINICAL STUDY REPORTS 

5.1       Table of Contents of Module 5          

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  

5.3.1.2 Comparative BA and Bioequivalence (BE) Study Reports  

5.3.1.3 In vitro-In vivo Correlation Study Reports   

5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human Studies         

5.3.2    Reports of Studies Pertinent to Pharmacokinetics using Human Biomaterials           

5.3.2.1 Plasma Protein Binding Study Reports         

5.3.2.2 Reports of Hepatic Metabolism and Drug Interaction Studies         

5.3.2.3 Reports of Studies Using Other Human Biomaterials          

5.3.3    Reports of Human Pharmacokinetic (PK) Studies    

5.3.3.1 Healthy Subject PK and Initial Tolerability Study Reports  

5.3.3.2 Patient PK and Initial Tolerability Study Reports    

5.3.3.3 Intrinsic Factor PK Study Reports    

5.3.3.4 Extrinsic Factor PK Study Reports   

5.3.3.5 Population PK Study Reports

5.3.4    Reports of Human Pharmacodynamic (PD) Studies 

5.3.4.1 Healthy Subject PD and PK/PD Study Reports        

5.3.4.2 Patient PD and PK/PD Study Reports           

5.3.5    Reports of Efficacy and Safety Studies         

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

5.3.5.2 Study Reports of Uncontrolled Clinical Studies       

5.3.5.3 Reports of Analyses of Data from More Than One Study    

5.3.5.4 Other Clinical Study Reports

5.3.6    Reports of Post-Marketing Experience         

5.3.7    Case Report Forms and Individual Patient Listings 

5.4       Literature References

 

Module 5 : CLINICAL STUDY REPORTS 

5.1       Table of Contents of Module 5          

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  

5.3.1.2 Comparative BA and Bioequivalence (BE) Study Reports  

5.3.1.3 In vitro-In vivo Correlation Study Reports   

5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human Studies         

5.3.2    Reports of Studies Pertinent to Pharmacokinetics using Human Biomaterials           

5.3.2.1 Plasma Protein Binding Study Reports         

5.3.2.2 Reports of Hepatic Metabolism and Drug Interaction Studies         

5.3.2.3 Reports of Studies Using Other Human Biomaterials          

5.3.3    Reports of Human Pharmacokinetic (PK) Studies    

5.3.3.1 Healthy Subject PK and Initial Tolerability Study Reports  

5.3.3.2 Patient PK and Initial Tolerability Study Reports    

5.3.3.3 Intrinsic Factor PK Study Reports    

5.3.3.4 Extrinsic Factor PK Study Reports   

5.3.3.5 Population PK Study Reports

5.3.4    Reports of Human Pharmacodynamic (PD) Studies 

5.3.4.1 Healthy Subject PD and PK/PD Study Reports        

5.3.4.2 Patient PD and PK/PD Study Reports           

5.3.5    Reports of Efficacy and Safety Studies         

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

5.3.5.2 Study Reports of Uncontrolled Clinical Studies       

5.3.5.3 Reports of Analyses of Data from More Than One Study    

5.3.5.4 Other Clinical Study Reports

5.3.6    Reports of Post-Marketing Experience         

5.3.7    Case Report Forms and Individual Patient Listings 

5.4       Literature References