The paper "The Role of Pharmacometrics in Drug Development" is an excellent example of a research proposal on medical science. Pharmacometrics defines the branch of science that “quantifies drugs, disease, and trial information” (Food and drug administration, 2010, p. 1). It 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 (2010, p. 1). Its trend in development has increased with extension to studies of drug effects on pharmacokinetics and pharmacodynamics (Vajja and Kumar 2011, p. 1). The application has been associated with benefits such as forecasting effects of drugs on use (Karlsson, 2010, p. 58-60).
Pharmacometrics remains an unexplored area of science despite its identifiable significance to the drug development and evaluation fields that have remained costly and with many inefficiencies (Huang, Li, Ette and Williams, 2007, p. 1). Training of experts in this field has also been insufficient and the high demand and high rewards for existing experts explain this (Barret, Fossler, Cadiew and Gastonguay, 2011, p. 434-446).
Statement of the problem
The unexplored scope of the branch of science together with the rising demand identifies its significant role but studies have not explored this role. The proposed study seeks to investigate the role of pharmacometrics in drug development.
Purpose of the study
The study aims at identifying the role of pharmacometrics in drug development to improve efficiency and establish its significance as an independent career area.
The study seeks to explore the following research question.
Does pharmacometrics play a significant role in drug development?
Pharmacometrics has been identified as an important factor in drug development and enhances accuracy in dosage (Smith and Vincent, 2010, p. 141- 143). This is significant has established the need for adequate training among clinical pharmacologists in the drug development field (Holford and Karlsson, 2007, p. 103- 105; Ingwersen et al., 2012, p. 1819- 1823; Smith and Marshal, 2011, p. 616- 621; Marier, 2011, p. 28 ). Pharmacometrics, in its analytical approach, informs drug development processes through developing empirical evidence on nature of drugs (Goldberg et al., 2010, p. 159- 160; Zheng, Li and Jin 2012, p. 1337- 1338; Peck and Kimko, 2011, p. 1- 11; Trivedi, Lee and Meibohm, 2013, p. 64-169; Krudys et al. 2011, p. 697- 703). This has been instrumental to success in the discovery of new drugs and sound regulatory policies on drug development and application. The ability of the science to promote regulation and adherence to regulations is similarly identified its application in advocating models for drug development (Zang, Pfister and Meibohm, 2008, p. 554-559; Lee et al 2011, p. 628-635). Dose-control trials are for example identified for its effectiveness towards its advocacy (Lledo et al. 2012, p. 29-38) and other models pharmacometrics models have been instrumental in diversified clinical trials (Sanders, 2012, p. 18-19).
The study that will explore differences between a drug that are developed under pharmacometrics application and developed drugs without the applications will apply quantitative research methods. The method is suitable because the nature of data to be reviewed, application and non-application of pharmacometrics and level of efficiency in development and quality of drugs, are quantitative data (Katsirikou and Skiadas, 2010, p. 10; Cottrell and McKenzie, 2010, p. 4).
Population and sample
Drugs that have been developed in the past five years will be the study’s population. A sample of 49 drugs will be selected and stratified random sampling applied with application and non-application of pharmacometrics in the development process as the stratification basis (Jonson and Christensen, 2010, p. 239; Vanderstoep and Johnson, 2008, p. n.p.).
Data will be collected from the Food and Drug Administration, a government agency that licenses new drugs.
The study will maintain the anonymity of investigated drugs and processes and ensure that no party suffers harm (Vaus, n.p.; Grace, 2009, p. 178).
The study will apply regression analysis to identify the existence of a significant relationship between the level of application of pharmacometrics and results of drug development (Bingham, Bingham, and Fry, p. 33; Weinberg and Abramowitz, 2008, p. 400). Analysis of variance will also be used to identify differences between application and non-application of pharmacometrics (Mitchel and Jolley, 2009, p. 447; Broyles, 2006, p. 248).