The Role of Pharmacometric in Drug Development – Research Proposal Example
The role of pharmacometric in drug development Introduction and rationale Pharmacometrics defines the branch of science that “quantifies drugs, disease and trial information” (Food and drug administration, 2010, p. 1). It generate 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 (2010, p. 1). Its trend in development has increased with extension to studies of drug effects on pharmacokinetis 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 fiels that has remained costly and with much inefficiency (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 explains 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 a its significant role but studies have not explored this role. The proposed study seeks to investigate the role of pharmacometric in drug development.
Purpose of the study
The study aims at identifying the role of pharmacometric in drug development to improve on efficiency and establish its significance as an independent career area.
The study seeks to explore the following research question.
Does pharmacometric play a significant role in drug development?
Pharmacometrics has been identified as an important factor to drug development and enhance 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 this has been instrumental to success in 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 is for example identified for its effectivens towards its advocacy (Lledo et al. 2012, p. 29-38) and other models pharmacometric models have been instrumental in diversified clinical trials (Sanders, 2012, p. 18-19).
The study that will explore differences between drug that are developed under pharmacometric 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 pharmacometric and level of efficiency in development and quality of drungs, 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 pharmacometric in development process as the stratification basis (Jonson and Christensen, 2010, p. 239; Vanderstoep and Johnson, 2008, p. n.p.).
Data will be collected from Food and Drug Administration, government agency that licences new drugs.
The study will maintain anynomity of investigated drugs and processes and ensure that noparty suffer harm (Vaus, , n.p.; Grace, 2009, p. 178).
The study will apply regression analysis to identify existence of a significant relationship between 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).
Barret, J Fossler, M Cadiew, D and Gastonguay, M 2011. ‘Pharmacometrics: A multidisciplinary field to facilitate critical thinking in drug development and translational research settings,’ The Journal of Clinical Pharmacology, vol. 45, no. 5, pp. 632-649.
Bingham, N Bingham, N and Fry, M 2010, Regression: Linear models in statistics, Springer, London.
Broyles, R 2006, Fundamentals of statistics in health administration, Jones & Bartlett Learning, Hoboken.
Cottrell, R and McKenzie, J 2010, Health promotion & education research methods: Using the five chapter thesis model, Jones & Bartlett Learning, New Jersey.
Food and drug administration 2010, ‘Phamacometrics at FDA,’ Food and drug administration, P. 1, Retrieved June 23, 2013, < http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm167032.htm >.
Goldberg, J et al., 2010, ‘ASCPT task force for advancing pharmacometrics and integration into drug development,’ Clinical Pharmacology & Therapeutics, vol. 88, no. 2, pp. 158-161.
Grace, P 2009, Nursing ethics and professional responsibility in advanced practice, Jones & Bartlett Publishers, New Jersey.
Holford and Karlsson, 2007, ‘Time for quantitative clinical pharmacology: A proposal for a pharmacometrics curriculum,’ Clinical Pharmacology & Therapeutics, vol. 82, no. 1, pp. 1-3.
Huang, X Li, J Ette, E and Williams, P 2007, ‘Pharmacometrics: The science of quantitative pharmacology,’ American Journal of Pharmaceutical Education, vol. 71, no. 4: 75.
Ingwersen et al. 2012, ‘Dosing rationale for Liraglutide in type 2 diabetes mellitus: A pharmacometric assessment,’ Journal of Clinical Pharmacology, vol. 52, no. 12, pp. 1815- 1823.
Jonson, B and Christensen, L 2010, Educational research: Quantitative, qualitative and mixed approaches, SAGE, New York.
Karlsson, K 2010, ‘Benefits of phamacometric model based design and analysis of clinical trials,’ Uppsala University, Retrieved June 23, 2013, < http://uu.diva-portal.org/smash/get/diva2:360473/FULLTEXT01 >.
Katsirikou, A and Skiadas, C 2010, Qualitative and quantitative methods in libraries: Theory and applications : Proceedings of the international conference on QQML2009, Chania, Crete, Greece, 26-29 May 2009, World Scientific. London.
Krudys, K et al. 2011, ‘Knowledge management for efficient quantitative analysis during regulatory reviews,’ Expert Review of Clinical Pharmacology, vol. 4, no. 6, pp. 697- 703.
Lee, J et al 2011, ‘Impact of pharmacometric analysis on new drug approval and labeling decisions,’ Clinical Pharmacokinetics, vol. 50, no. 10, pp. 627-635.
Lledo, R et al. 2012, ‘Ethically attractive dose-finding designs for drugs with a narrow therapeutic index,’ Journal of Clinical Pharmacology, vol 52, no. 1, pp. 29- 38.
Marier, J 2011, ‘Paving way with pharmacometrics,’ Drug Discovery & Development, pp. 28-30.
Mitchel, M and Jolley, J 2009, Research design explained, Cengage Learning, Mason.
Peck, C and Kimko, C 2011, ‘Clinical trial simulation and quantitative pharmacology,’ Clinical Trial Simulation, pp. 1-11.
Sanders, C 2012, ‘Pharmacometric modeling to support pediatric clinical trials,’ Drug discovery & development.
Smith, M and Marshal, A 2011, ‘Importance of protocols for simulation studies in clinical drug development,’ Statistical Methods in Medical Research, vol. 20, no. 6, pp. 613- 622.
Smith, P and Vincent, J 2010, ‘Biostatistics and pharmacometrics: Quantitative sciences to propel drug development forward,’ Clinical Pharmacology & Therapeutics, vol. 88, no. 2, pp. 141-144.
Trivedi, A Lee, E and Meibohm, B 2013, ‘Application of pharmacometrics in the clinical development and pharmacotherapy,’ Expert Review of Clinical Pharmacology, vol. 6, no. 2, pp. 159-170.
Vajja and kumar, V 2011, ‘Application of pharmacometric methods to clinical toxicology studies,’ Otago University, Retrieved June 23, 2013, < http://otago.ourarchive.ac.nz/handle/10523/554 >.
Vanderstoep, S and Johnson, D 2008, Research methods for everyday life: Blending qualitative and quantitative approaches, John Wiley & Sons, New Jersey.
Vaus, D 2013, Surveys in social research, Routledge, New York.
Weinberg, S and Abramowitz, S 2008, Statistics using SPSS: An interactive approach, Cambridge University Press, New York.
Zang, L Pfister, M and Meibohm, B 2008, ‘Concepts and challenges in quantitative pharmacology and model based drug development,’ AAPS Journal, vol. 10, no. 4, pp. 552-559.
Zheng, L Li, and Jin, L 2012, ‘Pharmacometrics: A quantitative tool of pharmacology,’ Acta Pharmacologica Sinica vol. 33, no. 11, pp. 1337-1338.