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Introduction

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It plays a crucial role in ensuring the safety and efficacy of pharmaceutical products in the market. Post-marketing drug surveillance is an important aspect of pharmacovigilance that involves monitoring the safety of drugs after they have been approved for marketing. This thesis aims to explore the paradigms of pharmacovigilance in post-marketing drug surveillance, focusing on the challenges and opportunities in this field.

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
– Historical development of pharmacovigilance
– Concepts and principles of pharmacovigilance
– Importance of post-marketing drug surveillance
– Challenges in post-marketing drug surveillance
– Opportunities for improvement in post-marketing drug surveillance
– Regulatory frameworks for pharmacovigilance
– Global initiatives in pharmacovigilance
– Role of healthcare professionals in pharmacovigilance
– Role of patients in pharmacovigilance
– Future trends in pharmacovigilance

Chapter 3: Research Methodology
– Research design
– Data collection methods
– Data analysis techniques
– Sampling techniques
– Ethical considerations
– Limitations of the study
– Validity and reliability of data
– Research assumptions and limitations

Chapter 4: Discussion of Findings
– Overview of post-marketing drug surveillance practices
– Analysis of challenges faced in pharmacovigilance
– Evaluation of opportunities for improvement
– Comparison of regulatory frameworks in different countries
– Case studies of successful pharmacovigilance programs
– Recommendations for enhancing post-marketing drug surveillance

Chapter 5: Conclusion and Summary
– Summary of key findings
– Implications for practice
– Recommendations for future research
– Conclusion

Thesis Overview:

Pharmacovigilance is a critical aspect of drug safety, particularly in the post-marketing phase where real-world data is collected to monitor the safety of drugs in a wider population. This thesis will delve into the paradigms of pharmacovigilance in post-marketing drug surveillance, examining the challenges, opportunities, and regulatory frameworks in place. The literature review will provide a comprehensive overview of the historical development, principles, and global initiatives in pharmacovigilance. The research methodology will outline the design, data collection methods, and ethical considerations for the study. The discussion of findings will analyze current practices and suggest recommendations for improving post-marketing drug surveillance. The conclusion will summarize key findings and propose future research directions in the field of pharmacovigilance.

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