What are the different phases that a Drug Company goes through in order to bring a new drug product to market in the U.S. and Europe?

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What are the different phases that a Drug Company goes through in order to bring a new drug product to market in the U.S. and Europe?

PFIZER’S DRUG-TESTING STRATEGY IN NIGERIA.

Need 3-4 pages with refernaces.

Pfizer’s Drug-Testing Strategy in Nigeria

Read Management Focus: Pfizer’s Drug-Testing Strategy in Nigeria in chapter 4 of your text and write a paper in APA format that answers the following questions:

? What are the different phases that a Drug Company goes through in order to bring a new drug product to market in the U.S. and Europe?
? Did Pfizer behave unethically by rushing to take advantage of an epidemic in Nigeria to test experimental drugs on children?
? Should it have been less opportunistic and proceeded more carefully?
? Were corners cut with regard to patient consent in the rush to establish a trial?
? Did doctors keep patients on Trovan too long when they should have switched them to another medication?
? Is it ethical to test experimental drugs on children in a crisis setting in the developing world where the overall standard of health care is so much lower than in the developed world and proper protocols might not be followed?

Pfizer’s Drug-Testing Strategy in Nigeria

The drug development process is long, risky, and expensive. It can take 10 years and cost in excess of $500 mil- lion to develop a new drug. Moreover, between 80 and 90 percent of drug candidates fail in clinical trials. Pharmaceutical companies rely upon a handful of successes to pay for their failures. Among the most successful of the world’s pharmaceutical companies is New York- based Pfizer. Given the risks and costs of developing a new drug, pharmaceutical companies will jump at opportunities to reduce them, and Pfizer thought it saw one.

Pfizer had been developing a novel antibiotic, Trovan, that was proving to be useful in treating a wide range of bacterial infections. Wall Street analysts were predicting that Trovan could be a blockbuster, one of a handful of drugs capable of generating sales of more than $1 billion a year. In 1996, Pfizer was pushing to submit data on Trovan’s efficacy to the Food and Drug Administration (FDA) for review. A favorable review would allow Pfizer to sell the drug in the United States, the world’s largest market. Pfizer wanted the drug to be approved for both adults and children, but it was having trouble finding sufficient numbers of sick children in the United States to test the drug on. Then a researcher at Pfizer read about an emerging epidemic of bacterial meningitis in Kano, Nigeria. This seemed like a quick way to test the drug on a large number of sick children.

Within weeks a team of six doctors had flown to Kano and were administering the drug, in oral form, to children with meningitis. Desperate for help, Nigerian authorities gave the go-ahead for Pfizer to give the drug to children (the epidemic would ultimately kill nearly 16,000 people). Over the next few weeks, Pfizer treated 198 children. The protocol called for half the patients to get Trovan and half to get a comparison antibiotic already approved for the treatment of children. After a few weeks, the Pfizer team left, the experiments complete. Trovan seemed to be about as effective and safe as the already approved antibiotic. The data from the trial were put into a package with data from other trials of Trovan and delivered to the FDA.

 

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Discuss how the goal of the community/organization aligns with your goal for this policy issue.

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Discuss how the goal of the community/organization aligns with your goal for this policy issue.

Policy, Politics, and Global Health

Introduction:??For this assessment, you will actively participate in policy development and implementation in order to advocate for policies that improve the health of the public and/or the nursing profession. You will utilize both a top-down and a bottom-up approach, bringing the nursing perspective to policy makers and stakeholders. You will identify the values and ethical perspectives that underpin your position and develop criteria to evaluate the success of your work. By the conclusion of the assessment, you will have a policy brief that can be sent to decision makers and a plan to work with an organization/community to promote policy change at the local level.??First, you will write a reflection on the following: 1) why you selected the health or nursing profession policy issue; 2) your values and the ethical positions that underpin your perspectives; and 3) the criteria you will use to evaluate the success (outcomes) of your proposed policy change. You will then write a policy brief for policy makers or stakeholders on the health or nursing profession issue with the purpose of initiating or supporting a top-down approach to policy. You will support your position with nursing research. Finally, you will create a plan from a bottom-up approach to promote a policy change within a community or organization utilizing the principles of community-based participatory research (CBPR). Please use the same issue throughout your project.??Requirements:
A. Analyze the values and ethics (suggested length of 2–3 pages) of a policy issue by doing the following:
1. Analyze a health or nursing profession policy issue that impacts a group of people and requires a policy change.
a. Discuss why you selected the issue.
b. Discuss the issue’s relevance to health or the nursing profession, using two pieces of academically appropriate literature from the last five years.
2. Analyze how your values impact your position on the policy issue.
a. Discuss the ethical principle (e.g., autonomy, beneficence, non-maleficence, justice) or theory (e.g., utilitarianism based on consequentialism; nursing and midwifery code of conduct based on deontological theory) that underpins your perspective.

 

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discuss and draw a conclusion as to whether this study will likely be exempt, expedited, or full review.

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discuss and draw a conclusion as to whether this study will likely be exempt, expedited, or full review.

Scenario
Two nurse researchers are interested in studying whether a pain assessment tool for critical care patients is valid and reliable when applied to a group of patients who cannot communicate verbally due to mechanical ventilation. They design a validation study in which randomly selected patients will be assessed using the tool after a painful procedure (tracheal suctioning) and after a non-painful procedure (oral care). If patient responses result in higher scores after the painful procedure than after the non-painful one, then the researchers will conclude that the tool is effective for these patients in differentiating pain responses from responses to nursing procedures in general.
Using the checklist in the text, discuss and draw a conclusion as to whether this study will likely be exempt, expedited, or full review. Explain your rationale.

 

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You are required to write two separate reflection using john model, each reflection must be 1200. The reflection must be on national safety and quality health standards encountered in clinical practice experience.

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You are required to write two separate reflection using john model, each reflection must be 1200. The reflection must be on national safety and quality health standards encountered in clinical practice experience.

The standards are attached along with the instruction. Use 5 references for each reflection.
2.The first reflection must be in clinical handover. Discussion must be about standard 6: clinical handover
The place was noisy, the assistance nursing personal were talking to each other and the other nurses as well were listening to the handover through the recorder. The registered nurse she missed piece of information which was the residence in room number x vomited twice during night and evening time. As a result, the residence received her percutaneous endoscopy gastrostomy without receiving any pre medication in regarding vomiting. The residence vomited large amounts of coffee ground fluid in the presence of assistance nursing personal ,she was looking pale, sick , she reported that she has severe pain in abdomen with acidity , she refuse to have her lunch . Doctor informed, eventually she transferred to health facility , remain there for two days
3-The second reflection must be about administering medication. The discussion must be about standard 4 medication safety .Registered nurses, they sign the medication, before giving them to the residence.
in the aged care facility , while I was attending the medication administration procedure under the registered nurse supervision, after I administered 10 mg Lasix tab , when I signed it , I noticed that the registered nurse have signed all the medications for all the residences before administration .when , I asked about the reason, she said to save time, I am working her since long time, I know all the residences and their medication.
4.Write the reflection, follow john model.
5.Critically analyze the situation using all the steps of john model.
6. write according to the steps mentioned in the marking guidline.
7. you can modify the situation , add any information to it.
Marking Guide

Needs Very
Improvement Satisfactory Mark
Basis of Quality and Safety Standard A brief overview of the need for the Quality and Safety Standard relevant to the clinical setting

What does this standards tell us about how we need to think about patient safety in the aged care or community setting? Consider the details of the standard. /5
Aims and objectives Describe the major aims and objectives of the selected Quality and Safety Standard in the clinical setting. How were the aims and objective of the standard ‘observable’ during the practice experience ? Can you suggest how these Standard aims need to be adopted in the setting? /5
Reflection Reflect on your clinical experience:

Describe the situations or circumstances when you applied the standard? How did you cope?

Describe any emotions experienced at the time?

How/what did you interpret, discriminate or relate essential information necessary for the application/evaluation of the standard?

Describe information you synthesized to determine compliance with the standard

Contemplate what you have learnt from this process and what you would do differently next time /5
References Claims and recommendations supported with appropriate evidence based literature. Minimum 5 – 7 references /5
TOTAL /20

 

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Incidence of failure to rescue, which could potentially result in increased morbidity or mortality

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Incidence of failure to rescue, which could potentially result in increased morbidity or mortality

Competencies:
734.3.1: Principles of Leadership – The graduate applies principles of leadership to promote high-quality healthcare in a variety of settings through the application of sound leadership principles.
734.3.2: Interdisciplinary Collaboration – The graduate applies theoretical principles necessary for effective participation in an interdisciplinary team.
734.3.3: Quality and Patient Safety – The graduate applies quality improvement processes intended to achieve optimal healthcare outcomes, contributing to and supporting a culture of safety.
734.3.4: Healthcare Utilization and Finance – The graduate analyzes financial implications related to healthcare delivery, reimbursement, access, and national initiatives.

Introduction:

National initiatives driven by the American Nurses Association have determined nursing-sensitive outcome indicators that are intended to focus plans and programs to increase quality and safety in patient care. The following outcomes are commonly used nursing-sensitive indicators:

• Complications such as urinary tract infections, pressure ulcers, hospital acquired pneumonia, and DVT

• Patient falls

• Surgical patient complications, including infection, pulmonary failure, and metabolic derangement

• Length of patient hospital stay

• Restraint prevalence

• Incidence of failure to rescue, which could potentially result in increased morbidity or mortality

• Patient satisfaction

• Nurse satisfaction and staffing…

 

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Explain how your proposed resolution to the problem would uphold the organization’s mission

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Explain how your proposed resolution to the problem would uphold the organization’s mission

To prepare:
• Review the Meyer article, “Nursing Services Delivery Theory: An Open System Approach,” in this week’s Learning Resources. Focus especially on the information presented in Table 1 (p. 2831) and Figure 2 (p. 2833).
• Reflect on your organization or one with which you are familiar. Within a particular department or unit in this organization, identify a problem the staff is encountering.
• Using Table 1 in the Meyer article as a guide, analyze the department or unit, identifying inputs, throughput, output, cycles of events, and negative feedback. Consider whether the problem you have selected relates to input, throughput, output, cycles of events, and/or negative feedback.
• Think about how you could address the problem: Consider what a desired outcome would be, then formulate related goals and objectives, and translate those goals into policies and procedures.
• Research professional standards that are pertinent to your identified problem.
• Reflect on the organization’s mission statement and values. In addition, consider how addressing this problem would uphold the mission and values, while improving the organizational culture and climate. (Depending on the organization you have selected, you may have explored these in the Week 1 Discussion.)
To complete:
By Day 7
Write a 3- to 5-page paper (page count does not include title and reference page) that addresses the following:
• Describe a department or unit within a health care organization using systems theory terminology. Include a description of inputs, throughput, output, cycles of events, and negative feedback.
• Describe the problem you identified within the department or unit using an open- systems approach, and state where the problem exists using the systems theory model (input, throughput, output, cycles of events, or negative feedback).
• Based on this information, explain how you would address the problem as follows:
o Formulate a desired outcome.
o Identify goals and objectives that would facilitate that outcome.
o Translate those goals and objectives into policies and procedures for the department or unit.
o Describe relevant professional standards.
• Explain how your proposed resolution to the problem would uphold the organization’s mission and values and imp

 

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A patient with aortic stenosis has come into the clinic with dyspnea, orthopnea, cough, and chest pain. Explain in your own words why these particular symptoms develop in people with aortic stenosis.

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A patient with aortic stenosis has come into the clinic with dyspnea, orthopnea, cough, and chest pain. Explain in your own words why these particular symptoms develop in people with aortic stenosis.

1- Your clinic patient has been newly diagnosed with hypertensive cardiomyopathy. He asks you to explain his disease in language that he can understand. How will you explain this disorder to him in lay terms?

2- A patient with aortic stenosis has come into the clinic with dyspnea, orthopnea, cough, and chest pain. Explain in your own words why these particular symptoms develop in people with aortic stenosis.

3- Your patient with valvular heart disease has been prescribed prophylactic antibiotic therapy because she is going to the dentist. In your own words, explain the reason why antibiotics are important in this situation.

4- A 3-year-old child develops strep throat and subsequent rheumatic heart disease (RHD). Describe the relationship between strep throat and development of RHD.

5- Your neighbor with severe chronic obstructive pulmonary disease (COPD) has developed heart failure. Based on his underlying disease, what type of heart failure does he likely have and how did he develop it?

PART 2

1. The two main reasons for the resurgence in TB are HIV and drug-resistant strains of the organism. Why is this so?

2. What other factors can you think of that have contributed to this rise?

 

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Explain the principles of effective classification (intervention).Please read “How to Prevent Prisoner Reentry Programs From Failing” by Listwan et al. beginning on page 303 of your Latessa/Holsinger text.

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Explain the principles of effective classification (intervention).Please read “How to Prevent Prisoner Reentry Programs From Failing” by Listwan et al. beginning on page 303 of your Latessa/Holsinger text.

Answer the following questions accordingly. Your responses should be based in what you have read. Please include citations throughout, as well as references in APA format. Your response is worth 20 points and should be thorough. Your response is due by 11:59pm on Day 7. Please upload your response in a WORD document.

1) Explain the principles of effective classification (intervention).

2) The article provides a detailed description as to what works effectively with the offender population. If we know what works, why is our recidivism rate so high?

3) The article suggests significant findings that cognitive behavioral treatment works well with the offender population. Given what you know about T4C, a cognitive behavioral treatment program, make an argument that the criminal justice system should use T4C with all offenders? How would this look? Would it work to curb recidivism? Why or why not?

 

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What roles do laboratory experiments and naturalistic observation play in cognitive research?

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What roles do laboratory experiments and naturalistic observation play in cognitive research?
DQ 1

For these discussion questions, please use correct APA references and citations. I need at least 250 words for each question. Also, please make sure nothing is plagiarized because my professor will be checking each assignment carefully.
CH. 1
What roles do laboratory experiments and naturalistic observation play in cognitive research?
What similarities and differences exist among the following three schools of psychology: structuralism, functionalism, and behaviorism?
What was the “cognitive revolution”? What resulted from it?
CH. 2
Describe the functions of the four lobes of the cerebral cortex.
Compare and contrast the various brain-imaging and brain-recording techniques.
CH. 12
What are the major assumptions of stage theories of development?
Explain how, in Piagetian Theory, cognitive structures adapt during the course of development.
In cognition, one major area of discussion is the influence of nature and nurture. What is the concept of nature-nurture, and why is it important in the study of cognition?
Do you believe it is possible to create a computer that can surpass human cognitive abilities? Why or why not?

 

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Are developing appropriate critical thinking, clinical reasoning and sound clinical decision making processes and strategies essential for safe, evidence-based and competent nursing practice in medical/surgical settings.

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Are developing appropriate critical thinking, clinical reasoning and sound clinical decision making processes and strategies essential for safe, evidence-based and competent nursing practice in medical/surgical settings.

Nursing Practice

Assessment 1: Case Study
Nursing management of a patient requiring hospitalisation

Length: 2500 words

The aim and purpose of Assessment 1 is to provide students the opportunity to demonstrate they:

• Are developing their ability to locate, interpret, integrate, synthesize and apply nursing knowledge from NUR243, other units they have comleted and a range of current, reliable sources to a patient or scenario they may meet in day to day nursing practice in medical/surgical settings
• Are developing appropriate critical thinking, clinical reasoning and sound clinical decision making processes and strategies essential for safe, evidence-based and competent nursing practice in medical/surgical settings
• Are able to focus their attention to the needs of the individual patient as the key concern of nursing practice in health care settings
• Have a developing understanding of the role and scope of practice of the registered nurse in the Australian health care context
• Are progressing towards the level of professional written communication required for nursing practice in Australia
• Are demonstrating ethical and professional practice by adhering to the University’s academic integrity standards and plagiarism policy

 

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