The Federal Drug Administration (FDA) is the regulatory body that reviews and approves or denies the addition of each new drug submission. The steps for development and marketing new drugs are as follows:
1) Stage 1- Preclinical trials: Discovery and development is the beginning of this phase. Once developed a new drug is tested in vitro or in test tubes and controlled environments outside living organisms or on animals to determine pharmacological activity, therapeutic potential, toxicology, and safety parameters that will become the recommendations for use. The developing company can file an application for investigational new drug (IND) through the FDA if a therapeutic benefit is discovered to be present. If FDA approves the IND application, the developer can proceed to Clinical Investigation. Stage one generally takes between 1-3 years.
2) Stage 2- Clinical Investigation: This stage will have at least 3 clinical trials and could take anywhere from 2-10 years. Pediatric and pregnancy testing are not always done in this timeframe.
a) Clinical Phase I involves testing new compound on relatively small groups of otherwise healthy individuals to determine tolerance, absorption, distribution, metabolism, and excretion of the drug.
b) Clinical Phase II is focused on testing with patients who have a particular disease process to determine safety and effectiveness in these patients who are generally on other medications and may have additional co-morbidities.
c) Clinical Phase III is designed to test drug efficacy when used in specific applications for a targeted group of patients.
3) Stage 3-Once all phases of clinical trials are completed results are reviewed along with a new drug application (NDA) by the FDA. This process can take anywhere from 2 months to 10 years and the FDA can ask for further information at any point in the process. When it is initially submitted the FDA has 60 days to determine if the NDA meets requirements to be considered for review at all.
4) Stage 4- Post-marketing studies continue monitoring after the drug has hit the market. This is where processes like adverse reaction reporting can play a role in the further use or removal from the market for new drugs. (Woo and Robinson, 2016)
Shingrix is a recombinant, adjuvanted vaccine against the virus that causes shingles and is specifically indicated for the prevention of herpes zoster (shingles) in adults aged 50 years and older. The FDA approval of Shingrix was based on a randomized, placebo-controlled, observer-blind clinical study conducted in 18 countries. The increased effectiveness has not displayed additional side effects other than what is typical with many vaccines. Adverse effects associated with the use of Shingrix may include, but are not limited to, the following: pain, redness or swelling at injection site, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptoms. Increased effectiveness for a larger number of patients without additional adverse effects indicates that this is a good drug and approval was appropriate.
Shingrix (Zoster Vaccine Recombinant, Adjuvanted). (n.d.)., Federal Drug Administration, Retrieved January 22, 2018, from http://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100232/shingrix-zoster-vaccine-recombinant-adjuvanted-
Woo, T. M., & Robinson, M. V. (2016). Pharmacotherapeutics for advanced practice nurse prescribers (4th ed.). Philadelphia, PA: F.A. Davis.
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W2a1 Research
/in Uncategorized /by developerSurvey Research
Survey research is a common method to collect data in a research project.
Using the South University Online Library or the Internet, select a public health issue or topic you feel needs to be addressed in your community. Based on your research, respond to the following regarding the public health issue you selected:
Assignment 1: Discussion Assignment
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W2a1topics
/in Uncategorized /by developerBased on your review of the Web site, select one of the ten regions of the EPA to evaluate its collaboration with other agencies in the event of an environmental disaster. Then, respond to the following:
Support your statements with appropriate examples and scholarly references.
Part 2: Implications of a Global Environmental Disaster
In addition to the environmental impacts of a natural disaster, the toll on the mental health of the affected population is enormous. The earthquake that occurred in Japan on March 11, 2011, resulted in mass casualties and structural damage beyond our imagination. In such events, the mental healthcare response is crucial for meeting the needs of the people affected.
Review the following journal article:
Using the readings for this week, as well as the above journal article, respond to the following:
Support your statements with appropriate examples and scholarly references.
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W2h1a
/in Uncategorized /by developerDefine critical thinking and evidence-based practice. Discuss what critical thinking in nursing practice entails and explain why it is important. Discuss the role of critical thinking and evidence-based practice as they relate to patient outcomes.
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W2h1a1206
/in Uncategorized /by developerFamily Health Assessment Part I
Understanding family structure and style is essential to patient and family care. Conducting a family interview and needs assessment gathers information to identify strengths, as well as potential barriers to health. This information ultimately helps develop family-centered strategies for support and guidance.
This family health assessment is a two-part assignment. The information you gather in this initial assignment will be utilized for the second assignment in Topic 3.
Develop an interview questionnaire to be used in a family-focused functional assessment. The questionnaire must include three open-ended, family-focused questions to assess functional health patterns for each of the following:
Select a family, other than your own, and seek permission from the family to conduct an interview. Utilize the interview questions complied in your interview questionnaire to conduct a family-focused functional assessment. Document the responses as you conduct the interview.
Upon completion of the interview, write a 750-1,000-word paper. Analyze your assessment findings. Submit your questionnaire as an appendix with your assignment.
Include the following in your paper:
Cite at least three peer-reviewed or scholarly sources to complete this assignment. Sources should be published within the last 5 years and appropriate for the assignment criteria.
Prepare this assignment according to the guidelines found in the APA Style Guide. An abstract is not required.
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W2h1b
/in Uncategorized /by developerDescribe how the nursing profession is viewed by the general public. Discuss factors that influence the public’s perception of nursing? Describe ways to educate the general public on the professional nurse’s role and scope of nursing within a changing health care system.
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W3dq2
/in Uncategorized /by developerThe Federal Drug Administration (FDA) is the regulatory body that reviews and approves or denies the addition of each new drug submission. The steps for development and marketing new drugs are as follows:
1) Stage 1- Preclinical trials: Discovery and development is the beginning of this phase. Once developed a new drug is tested in vitro or in test tubes and controlled environments outside living organisms or on animals to determine pharmacological activity, therapeutic potential, toxicology, and safety parameters that will become the recommendations for use. The developing company can file an application for investigational new drug (IND) through the FDA if a therapeutic benefit is discovered to be present. If FDA approves the IND application, the developer can proceed to Clinical Investigation. Stage one generally takes between 1-3 years.
2) Stage 2- Clinical Investigation: This stage will have at least 3 clinical trials and could take anywhere from 2-10 years. Pediatric and pregnancy testing are not always done in this timeframe.
a) Clinical Phase I involves testing new compound on relatively small groups of otherwise healthy individuals to determine tolerance, absorption, distribution, metabolism, and excretion of the drug.
b) Clinical Phase II is focused on testing with patients who have a particular disease process to determine safety and effectiveness in these patients who are generally on other medications and may have additional co-morbidities.
c) Clinical Phase III is designed to test drug efficacy when used in specific applications for a targeted group of patients.
3) Stage 3-Once all phases of clinical trials are completed results are reviewed along with a new drug application (NDA) by the FDA. This process can take anywhere from 2 months to 10 years and the FDA can ask for further information at any point in the process. When it is initially submitted the FDA has 60 days to determine if the NDA meets requirements to be considered for review at all.
4) Stage 4- Post-marketing studies continue monitoring after the drug has hit the market. This is where processes like adverse reaction reporting can play a role in the further use or removal from the market for new drugs. (Woo and Robinson, 2016)
Shingrix is a recombinant, adjuvanted vaccine against the virus that causes shingles and is specifically indicated for the prevention of herpes zoster (shingles) in adults aged 50 years and older. The FDA approval of Shingrix was based on a randomized, placebo-controlled, observer-blind clinical study conducted in 18 countries. The increased effectiveness has not displayed additional side effects other than what is typical with many vaccines. Adverse effects associated with the use of Shingrix may include, but are not limited to, the following: pain, redness or swelling at injection site, myalgia, fatigue, headache, shivering, fever and gastrointestinal symptoms. Increased effectiveness for a larger number of patients without additional adverse effects indicates that this is a good drug and approval was appropriate.
Shingrix (Zoster Vaccine Recombinant, Adjuvanted). (n.d.)., Federal Drug Administration, Retrieved January 22, 2018, from http://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100232/shingrix-zoster-vaccine-recombinant-adjuvanted-
Woo, T. M., & Robinson, M. V. (2016). Pharmacotherapeutics for advanced practice nurse prescribers (4th ed.). Philadelphia, PA: F.A. Davis.
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W3h1
/in Uncategorized /by developerHow has nursing practice evolved over time? Discuss the key leaders and historical events that have influenced the advancement of nursing, nursing education, and nursing roles that are now part of the contemporary nursing profession.
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W3h2
/in Uncategorized /by developerDiscuss the difference between a nursing conceptual model and a nursing theory.
Select a nursing theory and provide a concise summary of it. Provide an example in nursing practice where the nursing theory you selected would be effective in managing patient care.
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W4h1
/in Uncategorized /by developerOutline the process for the development of nursing standards of practice for your state (Florida), including discussion of the entities involved in developing the standards of practice and how the standards of practice influence the nursing process for your areas of specialty.
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W4h1a
/in Uncategorized /by developerI need a comment for each Question
Question 1
Briefly discuss the importance of cultural diversity training in health care. How does it contribute to cultural competence in providing patient care? Please support the answer with references.
Questions 2
Describe some of the diets in which you have recommended to patients with specific disease processes such as Hypertension, Gout, and Diabetes Mellitus. Please support the answer with references.
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