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The role of Pharmacometric in Drug Development - Dissertation Example

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Acknowledgments I am grateful to my supervisor Dr. Peter Meredith for his guidance, patience and support throughout the dissertation process. Also he played a significant role in reviewing my progress and recommending necessary changes. I also thank Dr. William Miller for helping me to do the dissertation and for his support and guidance…
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The role of Pharmacometric in Drug Development
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Download file to see previous pages The study proposes a mixed research approach with non-experimental design and phenomenology design. Stratified random sampling will be used to sample 49 drugs, developed within the past five years, for qualitative studies while simple random sampling will be used to generate a sample of 19 human participants for qualitative studies. The study anticipates significant and quantifiable role of pharmacometrics on drug development processes based on observations from application of pharmacometrics on regulation processes and consumers’ perception of drug quality. Contents Chapter 1: Introduction 1.1. Introduction and rationale 6 1.2. Background Information 7 1.3. Problem Statement 10 1.4. Statement of Purpose 11 1.5. Research Questions and Hypothesis 11 1.6. Significance of the Research 12 1.7. Change implication of the study 14 1.8. Assumptions 15 1.9. Theoretical framework 17 1.10. Limitations 18 1.11. Transition statement 19 Chapter 2: Literature Review 2.1. Introduction 20 2.2. Significance of pharmacometrics 21 2.3. Pharmacometrics and drug development 25 2.4. Pharmacometrics and drug regulation 27 2.5. Pharmacometrics and perception on drug quality 30 Chapter 3: Methodology 3.1. Introduction 32 3.2. Research Questions 33 3.3. Research Method and research Design 33 3.4. Role of the Researcher 34 3.5. Facilitators 35 3.6. Participants 35 3.7. Instrumentation 36 3.8. Instruments’ Validity and Reliability 37 3.9. Sampling 37 3.10. Data Collection Procedure 38 3.11. Pilot Testing 38 3.12. Ethical Considerations 39 4.0. Results 40 5.0. Discussion 46 6.0. Conclusion 47 5.0. References 48 Chapter 1: Introduction 1.1. Introduction and rationale: Medicinal drugs are important and sensitive commodities and frameworks and agencies exist that seek to ensure the safety of developed products. Pharmacometrics is a common terminology in the drug development and regulatory process as its application has been increasing in the practice that requires efficiency and accuracy besides regulatory needs. The Food and Drug Administration (FDA), is a government agency in the USA that is responsible for regulating drugs and foods for safe utility and it defines Pharmacometrics as the branch of science that quantifies drugs, disease and trial information (Food and Drug Administration, 2010). The agency’s definition corresponds to Ette and Williams’ definition of an analytic approach to understanding pharmacology through quantitative methods (2007). The definition illustrates quantitative research methods for understanding application, functionality, and effects of drugs. The science generates necessary information in the process of drug development and application for regulatory measure as it facilitates understanding of associations among drug usage, body’s response to application and results of the applications in the body (Food and Drug Administration, 2010). Its trend in development has increased with extension to studies of drug effects on pharmacokinetis and pharmacodynamics. Drugs’ ...Download file to see next pagesRead More
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