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Introduction

In recent years, microdosing has emerged as a promising strategy in early drug development. Microdosing involves the administration of sub-therapeutic doses of a drug to human subjects in order to study its pharmacokinetics and pharmacodynamics. This approach offers several advantages over traditional dosing methods, including reduced risks of toxicity and the ability to study drug effects in humans at an early stage of development.

Despite the growing interest in microdosing, there is still a lack of comprehensive understanding of its potential benefits and limitations. This thesis aims to explore the various microdosing strategies used in clinical trials and their implications for early drug development. By examining the existing literature and conducting original research, this study seeks to provide insights into the utility of microdosing in drug development and its potential impact on patient outcomes.

Chapter 1: Introduction
1.1 Introduction
1.2 Background of study
1.3 Problem Statement
1.4 Objective of study
1.5 Limitation of study
1.6 Scope of study
1.7 Significance of study
1.8 Structure of the Thesis
1.9 Definition of terms

Chapter 2: Literature Review
2.1 Overview of microdosing in early drug development
2.2 Historical perspective of microdosing
2.3 Advantages and limitations of microdosing
2.4 Microdosing strategies and methodologies
2.5 Regulatory considerations in microdosing
2.6 Clinical applications of microdosing
2.7 Case studies of successful microdosing trials
2.8 Ethical considerations in microdosing research
2.9 Future directions in microdosing
2.10 Summary of key findings

Chapter 3: Research Methodology
3.1 Research design
3.2 Sampling and participant selection
3.3 Data collection methods
3.4 Data analysis techniques
3.5 Ethical considerations
3.6 Pilot testing procedures
3.7 Validity and reliability
3.8 Limitations of the study

Chapter 4: Discussion of Findings
4.1 Overview of research findings
4.2 Comparison of microdosing strategies
4.3 Implications for early drug development
4.4 Future directions for microdosing research
4.5 Recommendations for industry and regulatory bodies
4.6 Limitations of the study
4.7 Strengths and weaknesses of the research
4.8 Practical implications for drug development

Chapter 5: Conclusion and Summary
5.1 Summary of key findings
5.2 Contributions to the field
5.3 Implications for practice
5.4 Recommendations for future research
5.5 Conclusion

Overall, this thesis will provide a comprehensive overview of microdosing strategies and clinical trials in early drug development. By critically evaluating the existing literature and conducting original research, this study aims to contribute to the growing body of knowledge on microdosing and its potential impact on drug development practices.

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