Food and Drug Administration - Dissertation Example

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.

I would also like to appreciate my family and friends for the support that they offered through resources and encouragement. My classmates also played a fundamental role in the success of the research and I acknowledge their role.

Abbreviations
Abstract
Information on the application of pharmacometrics in drug development and associated regulatory processes is limited to descriptive knowledge and this study proposes an inferential approach to understanding the role of pharmacometrics in drug development and interaction between drug development processes, drug regulation processes, and consumers’ perception of associated drug quality.
Chapter 1: Introduction

1.1. Introduction and rationale:
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 the application, functionality, and effects of drugs. The science generates necessary information in the process of drug development and application for the 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 pharmacokinetics and pharmacodynamics. Drugs’ effects on the body help in determining their safety levels and their movements in the body together with the speed within which they can be excreted from the body are significant to both manufacturers and regulators and pharmacometrics offers the necessary data (Vajja and Kumar 2011). Such forms of data have also been associated with benefits such as forecasting effects of drugs on use, suggest an effective role of pharmacometrics that should be established (Karlsson, 2010).

1.2. Background information :
Pharmacometrics’ role remains an unexplored area of science despite its identifiable significance to drug development and evaluation fields that have remained costly and with many inefficiencies. Generated data from pharmacometrics processes have also received limited analytical attention despite their potential to improve drug development processes’ efficiency and reduce involved costs.