StudentShare
Contact Us
Sign In / Sign Up for FREE
Search
Go to advanced search...

The role of Pharmacometric in Drug Development - Dissertation Example

Comments (0) Cite this document
Summary
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…
Download full paperFile format: .doc, available for editing
GRAB THE BEST PAPER98.4% of users find it useful
The role of Pharmacometric in Drug Development
Read TextPreview

Extract of sample "The role of Pharmacometric in Drug Development"

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
Cite this document
  • APA
  • MLA
  • CHICAGO
(“The role of Pharmacometric in Drug Development Dissertation”, n.d.)
The role of Pharmacometric in Drug Development Dissertation. Retrieved from https://studentshare.org/health-sciences-medicine/1481572-the-role-of-pharmacometric-in-drug-development
(The Role of Pharmacometric in Drug Development Dissertation)
The Role of Pharmacometric in Drug Development Dissertation. https://studentshare.org/health-sciences-medicine/1481572-the-role-of-pharmacometric-in-drug-development.
“The Role of Pharmacometric in Drug Development Dissertation”, n.d. https://studentshare.org/health-sciences-medicine/1481572-the-role-of-pharmacometric-in-drug-development.
  • Cited: 0 times
Comments (0)
Click to create a comment or rate a document

CHECK THESE SAMPLES OF The role of Pharmacometric in Drug Development

Biologics Drug Discovery and Development

... fragments are the smallest antibody fragments which can retain binding to specific targets and have significant advantages in ease of engineering and are robust. They have been validated in the clinic with several products, up to phase 2/proof of concept. These are most suited for a local or topical delivery system, have great stability and are the easiest to manufacture. Resources Corr, P & Williams, D 2009, ‘The Pathway from Idea to Regulatory Approval: Examples for Drug Development,’ National Academy of Sciences, NCBI, Available from < http://www.ncbi.nlm.nih.gov/books/NBK22930/> [16 May 2013] Drug Discovery Today 2013, Crescendo Biologics Announces the Crescendo Mouse, Drug Discovery Today Online, Available from < http...
5 Pages(1250 words)Essay

Pharmacokinetics in drug development: successes and failures

...? Pharmacokinetics in drug development: successes and failures Introduction Pharmacokinetics as well as pharmacodynamics are related concepts of in pharmacology. The administration of drugs into the bodies of organisms require effective diagnosis and evaluation to ensure the use of the appropriate drug in treating a disease in the bodies of the organisms. Pharmacodynamics is the study of physiological and biochemical effects of drugs in the bodies of the disease causing microorganisms or parasites residing in other organisms. Drugs are chemical substances administered into the bodies of the organism in order to eliminate a pathogen thereby alleviating the discomfort resulting from such. Being an external chemical substance, the organisms...
5 Pages(1250 words)Essay

Drug Development Process

...Drug Development Process Drug development is the process by which new therapies are created and brought to market to treat diseases. Drug should undergo a process before it will be able to approve by the Food and Drug Administration (FDA) and before it will be marketed. The Food and Drug Administration ensures the safety and efficacy of the drug being marketed. The FDA requires examining the efficacy of the drug thru well-controlled trials, the effectiveness of the drug should be determined and the safety of the drug to be developed is checked before approving the medication for market. The Drug Development Process includes 12 steps; 1) Disease State 2) Metabolic Pathway / Gene Pathway, 3) 3) Molecular Specificity, 4) 4) Quantitative...
6 Pages(1500 words)Essay

The role of race in drug prosecutions

...The Role Of Race in the attitudes of the criminal justice system to Drug Prosecutions A study of the South Asian Community This study is aimed at exploring the social and academic attitudes of how race remains an integral variable in the determination of drugs and violence and perceptions of a crime. The Study is original in the sense that few if any of the members of the academia like to venture into unchartered and sensitive waters of race as this issue sparks immense controversy. My study aims to discover why South Asian minorities are suffering today from racial bias by the general public as well as the police force in drug related crimes will explore the legal, moral and historical premises behind all the increasing tendency of South...
30 Pages(7500 words)Essay

The Role Immigration Plays in Drug Trafficiking

...The Role of Immigration in Drug Trafficking Introduction Drug Trafficking is a crucial link between the making and the use of unlawful drug. Drug trafficking is mainly comprised of certain factors that include management chain and hierarchy, demand and supply market and the people who traffic. The various participants of drug trafficking include drug mafia, transnational immoral groups and terrorists among others. All these participants are important links in the chain of drug trafficking (Madi, 2003). It has been prominent that especially the practice of drug trafficking is considered as one of the serious issues confronting both advanced and progressed nations. Production, operation and use of unlawful drugs are the ultimate danger...
7 Pages(1750 words)Research Paper

Sex-Role Development

...Sex Role Development There are double-standards in our society, boys can do a thing and get away with it but when girls do the very same thing they are punished and castigated. This paper will shed more light upon the gender differences in our society. There is little doubt about the fact that our society is full of stereotypes, girls and boys are both brought up very differently from one another. Girls are taught to be sensitive; on the contrary boys are made rough and tough. Parents play a pivotal role in passing their beliefs on to their children, the way they think matters the most and the same also reflects on the thinking of their children. We live in a society, in which sons and daughters are treated very differently, pink...
1 Pages(250 words)Essay

Targets of Anti-metastatic Drug Development

... FAK and of the sole integrin alfa5betal subunits, Real time PCR analyses are advancing. The outcomes obtained to date confirm the important function of integrins, and specifically of alfa5betal integrin, in dissemination of colon cancer and propose that the NAMI_A anti-metastatic activity can rely on the changes of integrin roles of these tumour cells (Pelillo, Bergamo, and Sava, 2012, p. 2). This information proposes integrins to be target molecules for the new therapeutic strategies development. It can be concluded that efforts to get anti-metastatic drugs are in top gear and various studies have followed this noble course. The intention produces a solution to this deadly form of cancer (metastasis) and other cancer form...
6 Pages(1500 words)Essay

Drug Development and Toxicology

... many diseases that are related to today’s lifestyles as well as technology that can help in developing appropriate cures for these diseases. Slow clinic trials are a hindrance to these forms of development due to the phases involved and the unfulfilled roles of the drug developing companies. With faster and more cost effective clinical trials, it is possible to save on drug approval as well as reducing the number of deaths that are associated with modern diseases such as cancer and heart diseases. Works Cited Top of Form FRIEDHOFF, L. T. (2009). New drugs: an insider's guide to the FDA's new drug approval process, for scientists, investors, and patients. New York, Pharmaceutical Special Projects Group. Bottom of Form Top of Form...
4 Pages(1000 words)Essay

Drug Abuse and Social Worker Role

...Drug Abuse and Social Worker Role This paper discusses drug abuse and the role of a social worker in overcoming the social problem. In the discussion of drug abuse, the paper gives a capsule history of the problem, and also discusses how widespread is the social problem; also, the paper explains the population that the social problem of drug abuse affects. After the general discussion of the social problem, the paper discusses the role of a social worker in addressing the problem, and the methods that the social workers use in trying to solve the social problem. The paper concludes with a personal reflection on the values and the ethical issues related to the problem of drug abuse. Let us begin by looking at the general history of drug...
9 Pages(2250 words)Research Paper

Leadership Development Experience

The nine-month certificate program which I completed at Leadership Institute of South Puget Sound combined academic study on leadership with practical development of leadership skills. Numerous community service activities such as involvement in Employee Community Fund (ECF), being a Child haven volunteer, Christian Center volunteer and a Junior Achievement Consultant have exposed me to situations which made me apply many skills such counseling young people, and motivating them to achieve their full potential, seeking solutions with expansive thinking and application of flexibility and quick responsiveness. My involvement in Christian Center had specially sharpened my crisis management skills by participating in natural disaster m...
13 Pages(3250 words)Assignment

An Overcorrection of Mary Magdalenes Biblical Role

A purely theological approach to DVC would be impossible since the claims the book makes takes issue with what has been supposedly left out of the bible. This essay will in no way attempt to question whether any non-canonical gospels should be considered; that sort of investigation should be left to historians.

As Brandon Gilvin states in Solving the Da Vinci Code Mystery, “It’s difficult to start a discussion on the creation of the bible from the Bible itself” (7). As the word of God is being questioned, it does us no good to turn to the Gnostic Gospels, the main sources of the claims of Mary Magdalene’s and Jesus’ marriage. In these texts, Mary Magdalene is the most mentioned person after...
11 Pages(2750 words)Essay

The Effect of Democracy on Chinese Development

Any country first needs to go through economic liberalization and political liberalization before finally settling into a stable democratic situation. Democracy should not at any one point be viewed as if it were socialism, but should be seen as a means of promoting economic development through accountability and protection of individual lawful rights and interests...accountability in the sense that the respective leaders are able to fight corruption, enhance social harmony, strengthen public trust and more importantly empower government institutions that are directly in touch with the people (Liu, 2008, p.1-2). Owing to the Chinese well informed and affluent society on top of having a very dynamic economy, the political change wh...
7 Pages(1750 words)Coursework

The National Drug Intelligence Center

...The National Drug Intelligence Center One of the most common crime in the United s nowadays is of drug trafficking. This lucrative business has become a trend in the American society and is increasingly becoming a threat for the state. Just before this crime could become a national issue the government of United States realized its potential and formed several intelligence agencies which would look after the drug traffickers. The National Drug Intelligence Center is the formation of government of United States in this regard. It was formed in 1993 and is operating till date. The NDIC has proved quite successful in achieving its tasks and has proved as an asset to the United States. This essay would further describe the agency in detail...
8 Pages(2000 words)Essay

Marks and Spencer Organizational Development Process

... production and marketing techniques the company is aiming to attain world class position in the retail market field. Along with offering of highest quality products, customer servicing is also ensured by them for attaining loyal customer base. “Our brand values – quality, value, service, innovation and trust – are more important than ever. Our commitment to these values sets us apart from our competitors, and enables us to offer our customers something truly special.” (About us, 2009). An overview of Organizational Development process: According to Richard Beckhard, Organizational Development is “An effort (1) planned (2) organization-wide (3) managed from the top to (4) increase organization effectiveness and health through (5) planned...
7 Pages(1750 words)Case Study

An Evaluation of the Role That the Principles of Behaviour Therapy Have to Play in Clinical Hypnosis

Hamburg (2006) first used this combined effort to treat two patients who were scared of dying. He uses his paper to encourage clinicians to refrain from not using their knowledge at the introductory classes of hypnosis but to go into it deeper. Many therapists at that time were taking the bold step of combining behavior therapy with hypnosis (Chaves, 2006). One group used hypnosis for desensitization therapy (Kirsch et al, 1995). However, there was general disagreement about the manner of hypnosis being employed and the methods of mentalist constructs. Chaves who strongly believed in the treatment combination used it as a base for many of his therapeutic interventions (Chaves, 1997a as cited in Chaves, 2006). The hypnotic therapy...
8 Pages(2000 words)Article

Role of the Police and Private Security

...Report to the Legislator - Committee on Crime and Criminal Justice Congratulations on being appointed to the Committee on Crime and Criminal Justice. As a public servant you are holding a very responsible post that covers many areas of administration including the important role of providing security to the citizens of your constituency and to those individuals who visit it. This report will provide you with a clear picture on the role of security agencies with regard to homeland security. Many of the points mentioned here may be new or already known to you, but they are provided here in any case. It is common knowledge that apart from local and organized crime within the United States, the country is now facing new forms of threats like...
8 Pages(2000 words)Case Study

Comparison of Leading Womens Role in Portrait of Teresa and Salt of Sea

... Number] Comparison of leading Women’s role in Portrait of Teresa and Salt of Sea Every society has different values,traditions and perceptions regarding the role of women that fit within their historical, cultural and social contexts. The cinema being an important cultural institution and reflector of social values tends to depict the role of women in movies to refer their current status as well as to motivate them playing a non traditional role for some specified purposes. In the movies “Portrait of Teresa” and “Salt of the earth” also, the directors Pastor Vega and Herbert Biberman have presented the roles of women in quite encouraging manner to show the women’s potential of playing a revolutionary and defining role in setting up trends...
7 Pages(1750 words)Case Study

Communication Role at the Workplace

Internal communication in any organization has been found to play a significant role in regard to role achievement in any business venture. When the internal communication department closely works with the top management, it has been found that job satisfaction levels rise which in effect translates to higher individual and group output from the workers (HRM guide, 2009). It is the role of the internal communication department to ensure that the strategic organizational direction is passed on to all employees and followed as planned so as to guarantee the achievement of intended outcomes.
With the current developments towards globalization, knowledge availability has become more readily available and the economy has approache...
9 Pages(2250 words)Assignment

Cognitive Development in Childhood

The significance of cognitive development among children lies in the fact that the children learn, acquire and develop cognitive and social skills along with other interpersonal skills that help them grow as competent individuals.
This paper addresses the key issues of the development of cognition in children between three to five years. In this context, various theories of cognitive development are discussed briefly along with special reference to the cognitive theory of Piaget. The paper also looks carefully into the relevance of cognitive development during this age upon the development of other areas and skills of the child.
When it comes to the cognitive development of children, the name of Piaget is undoubtedly pri...
7 Pages(1750 words)Assignment

The Role of Drug Couriers and Drug Trafficking Industry

...; the existence of such organisations for trafficking other drugs is stated to be unknown. The second courier type, the self-employed courier has been examined by the company Gruppo Abele (2003). It explores the trafficking of synthetic drugs in the three European cities of Amsterdam, Barcelona, and Turin, and includes drug dealers who transport consignments of synthetic drugs by road, for sale and for personal use. The EMCDDA (2012, p.19) states that the category of “self-employed couriers includes those who organise the purchase of drugs from producers or brokers, and the transport and sale of drugs in the target country”, where they either sell the drugs themselves or develop associations with a wholesaler or broker. The role...
12 Pages(3000 words)Research Paper
sponsored ads
We use cookies to create the best experience for you. Keep on browsing if you are OK with that, or find out how to manage cookies.

Let us find you another Dissertation on topic The role of Pharmacometric in Drug Development for FREE!

Contact Us