New Drugs Stability Tests Seeking Approval from The FDA

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New Drugs Stability Tests Seeking Approval from The FDA

Please use the reference materials provided in this document along with trusted online resources. These references will provide you with a general understanding of stability testing and the reason of its key importance related to the overall drug development process. Choosing the API you used in Written Assignments 1 & 2 please complete a 7 pages paper that provides 1.) a summaryofstabilitytestingforthecompoundyouchose.2.)Specificstabilityteststhatwereran (if you can find specific report numbers that would be great) for the compound you selected. 3.) Provide a brief background on the Company/Sponsor that ran the tests (remember, the sponsor does not always run the tests, it could be a separate facility that ran the test) including their historywithinthespaceforthespecifictherapeuticareayouareworkingin.4.)Includeatleast

2-3 tables, graphs or figures supporting the stability data with clear understanding of its purpose. The tables can be your own and/or referenced via a finalized stability report.

Please do not count graph and tables in 7 pages.

MATERIALS

Stability Testing of New Drug Substances and Products

HTTP://WWW.ICH.ORG/PRODUCTS/GUIDELINES/QUALITY/QUALITY-SINGLE/ARTICLE/STABILITY-TESTING-OF-NEW-DRUG-

SUBSTANCES-AND-PRODUCTS.HTML

Guidance for Industry Q1A (R2) Stability Testing of New Drug Substances and Products

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073369.pdf

World Health Organization: Quality Assurance ofPharmaceuticals – A Compendium of Guidelines and Related Materials – Volume 1

http://apps.who.int/medicinedocs/en/d/Jh1813e/3.3.3.html

1

Drug Resources the Perindopril Tablet Drug

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Drug Resources the Perindopril Tablet Drug

This assignment is intended to acquaint you with drug information resources that you may refer to in the future. Using DailyMed website: http://dailymed.nlm.nih.gov/dailymed/about.cfm?CFID=199472492&CFTOKEN=913858b572967ed8-CA33F970-E4A8-F440-05268A0ADBB1303B&jsessionid=8430dba8a25c1e62b2477a4b454820227870

Official, package insert/FDA-approved product label info is listed on daily med. Find a drug your interested in or one that is being used by yourself or a family member. Once on the site click on “Full Table of Contents” to see the complete list of information available on the medication. You will need to look at several sections of the info to complete the assignment.

Drug Resources Assignment

Daily Med

1. Brand name

2. Generic name(s) of the active ingredient(s):

3. Manufacturer:

4.. Clinical Pharmaco-logy  What kind of drug is it? What is said about how it produces its effects?

5. What is it used for (“indications & usage”)

6. Who shouldn’t use it or who needs to be particularly cautious about use?

This info may be under headings like CONTRAINDICATIONS, WARNINGS, or PRECAUTIONS.

Statements, if any, concerning use of this med by:

A. Pregnant women?

B. Nursing women?

C. Children?

D. Elderly?

E. Those prone to substance abuse?

F. Those driving/operating machinery?

G. Those on other medication that would preclude the use of this drug?

H. Health conditions of particular concern that might make use dangerous?

8.a) What side effects are LIKELY to occur (common side effects)?

b) What more serious adverse effects are possible in some people?

9. Interactions with other drugs

10. What happens if your take too much (Overdosage)*

*some drugs won’t say much about this because it is so uncommon

1)Please find that drug where u get all the answer for question.

3) some are one word answer and some are in brief.

It will be $5 per page, so please bid depending on how much work is sufficient to answer and you will have to provide that much work to me (excluding the pages)

Systems for Healthcare System Development Life Cycle

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Systems for Healthcare System Development Life Cycle

HI300: Information Technology and Systems for Health Care

Discussion Topic: The System Development Life Cycle

INSTRUCTIONS: Respond to all posts; response to classmates should be thoughtful and advance the discussion. Response should make and/or frequent informed references to unit material or scientific literature. Follow APA style if resources are used, 75 word minimum in response per post.

 

CLASSMATE POST #1

I am the chief information officer for a network of nursing homes in Vermont. We are looking to implement new information systems throughout each facility in order to boost employee productivity.

Before starting anything, we must come up with a “game plan”. Without creating a plan, we do not know where the problem is and what we will have to fix. Without this information, implementing a new system will be a waste. The planning phase includes everything from identifying the problem to what it will cost. All necessary information should be identified here.

Systems for Healthcare System Development Life Cycle

The next step is where the “How?” takes place. This is where solutions are brainstormed and decided upon. This is where the requirements for the new system. Will be decided upon and the best solution/system will be picked based on this.

Next, the design phase comes into play. This is when the team gets down to the nitty gritty to design the new system. All technical specifics and features will be decided here.

The development phase is when the system is actually “put together”. The programmer or network engineer will follow the design and create the program.

A quality assurance professional will then use this program, run tests to identify bugs or issues, and then approve it to be implemented.

The implementation phase is when installation occurs. Ridding the facility of the old system and installing the new one is an important step that could be complicated. For a facility that runs 24/7, the installation will need to occur preferably during night hours.

The last phase includes ongoing maintenance and updates.

Systems for Healthcare System Development Life Cycle

Some questions I’d ask myself include: Do we have the necessary resources to complete the change? Do we have the money to finance this change? What is wrong with the old system? What key components does the new system need to have? How will we train current employees?

~Deana Mattison~

CLASSMATE POST #2

My name is Kassandra I am the chief information officer for Rivers Medical Center. Our facility is in need of a new EMR system, starting these kinds of changes can be very complex. Starting a plan phase which starts with getting feedback from the staff and other companies, the way their projects are being carried out with success. The second phase would be to communicate with the IT department to see what the options are to develop. However the best system possible, especially to be cost effective and easier access for all the employees. A productive option would be to try different types of systems. Figure out which one works the best for everyone. Having staff try the options and outweigh the best, most cost effective ways to upgrade such systems.

Systems for Healthcare System Development Life Cycle

Another phase is the coding software,  consequently  just getting the program started can be the most difficult process in the seven phases. Having even the slightest problem or glitch in this system can destroy everything, making the process start all over again. If having to start the programming over it could result in loss of time, money and investors.

Having someone or another company invest, like stock holders a set back could put the company back millions. I believe making sure the IT programmers are very highly informed of what we want specifically and make sure they are dedicated to the project. This brings us to our sixth phase, deployment, this is where we show the investors and staff what we have developed hoping for no mistakes or errors. The final stage is the maintenance cycle, this is to maintain the features installed and make sure there is no margin of error.

~Kassandra Thurlow~

Promoting Healthy Communities

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Promoting Healthy Communities

Assignment Content

  1. Part I

    Using the data from your family and community assessments, create a plan in which you:

    • Analyze the role of community/public health nursing and community partnerships as they apply to the participating family’s community.
    • Analyze the influence of social determinants of health, such as culture and access to resources, in the participating family’s community.
    • Compare epidemiological data for the participating family’s community to state-level data.
    • Select 1 Healthy People 2020 Leading Health Indicator (LHI) topic that relates to your participating family’s community and the identified problem that you developed in Week 2. Based on your selected LHI topic:
    • Identify at least 3 nursing interventions for the identified problem.
    • List health partnerships that assist in implementing the interventions to support improved health outcomes for the family.

    Format your assignment as one of the following:

    • 12- to 18-slide presentation with speaker notes on all slides
    • 700- to 1,050-word paper
    Part II

    Create a Health Education Action Plan. The plan will identify community health resources that support improved health outcomes for your selected family/community. Include:

    • Goal(s)
    • Planned action (interventions)
    • Needed resources (community resources)
    • Timeframe for evaluation (projected expectation for evaluating initial outcomes of action plan)

    Implement the Health Education Action Plan with your selected family.Write a 250- to 500-word summary of the implementation/teaching process, family response to action plan, and expectation for family compliance and improved health outcomes. Cite at least 1 peer-reviewed and 1 evidence-based reference.Include APA-formatted citations and a references page.
    Exception for presentations: Include a slide with APA-formatted references. Note: Remove all personally identifying information such as the family members’ names. Refer to family members by initials only. Format Part II of your assignment as one of the following:

    • 8- to 10-slide presentation
    • Brochure (6 sided)
    • Poster

Health & Medical Patient Centered Care

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Health & Medical Patient Centered Care

NUR3805 Nursing Role and Scope Research Paper # 2 The paper should address the following:

1. Describe the dimensions of Patient-Centered Care and how do you apply PCC in your current practice.

2. Effective communications between health care providers and the patient is an essential component of PCC, why?

3. Describe an interprofessional healthcare team in your area of work. Do the members work collaboratively? Do they improve patients’ outcomes, how?

4. Think about your experience as a nurse student, have you observed effective communication improve patients’ outcomes? Have you observed the impact of poor communication on patients’ outcomes?

The paper must be typed in APA format with a minimum of 1000 words (excluding first and references page). With a minimum of 4 evidence-based references within the past 5 years using the required Arial 12 font. Follow the APA example paper under the folder APA tools.

Make sure references are used according to APA guidelines. And electronic references must be from reliable sources such as CDC.

APA format 7th edition

Rubric

Cited 4 or more sources. Sources reliable, properly cited. Ideas well organized All information included. Sufficient information provided to support all elements of topic.

Research Topic includes all aspects of the project, appropriate length of paper and topic. Content relevant to purpose of paper Contains clear and appropriate organization. With effective transitions, introduction, and conclusion.

Consistent and appropriate writing style, there are no grammatical spelling errors. Appropriate punctuation used. Met min/max page requirements

All sources properly cited. References used appropriately in paper, no errors in references. Correct use of APA style references. Presence of in-text citations or quotations that supports the student statements within the paper. Peer reviewed journals within past 5 years

Test Batteries in Animal Models of Psychopathology

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Test Batteries in Animal Models of Psychopathology

The ANOVA test is an abbreviation for analysis of variance and these tests specialize in studies with three or more groups and contain two or more independent variables. Additionally, the ANOVA tests are preferable compared to the t-test, because the ANOVA prevents the risk of type 1 error due to the use of multiple groups. There are three types of ANOVA test and they are one-way ANOVA, one-way repeated-measures, and two-way ANOVA (Corty, 2016).

One-way ANOVA: Between-subjects vs. Within-subjects

One-way ANOVA compares the means of three or more groups to examine if they are different from one another or if they are the same. There are two types of one-way ANOVA test and they are between-subjects and within-subjects. One-way between-subject ANOVA depicts a test where the compared groups are not related in any way and the participants are independent from one another. Additionally, this type of tests is based on the different treatments that the different groups receives. For example, a researcher has three groups that were randomly selected where age, sex, and weight are completely different. Group one smoked one cigarette, group two smoked half pack of cigarettes, and group three smoked one pack of cigarettes. This difference in cigarettes smoked shows that each group had different treatments and did not experience the same effects because of age, sex, and weight.

Whereas, within-subjects means the participants are related in some way, therefore, the groups received the same treatment but different individual effects. For example, group one, group two, and group three smoked half pack of cigarettes, but the effect on the individuals will be different due to height, weight, age, sex, if they ate before the test, and nicotine tolerance (Corty, 2016).

One-way repeated-measures ANOVA

One-way repeated-measures ANOVA compares the means of three or more dependent samples and examines if the means are different or the same when the participants are the same in each group. This test is used to measure studies with the same cases measure under multiple conditions, and the same cases measured at multiple points of time. For example, examining alcohol tolerance of college students over a period of time, such as a group of freshmen compared to the same set of participants over the next four years of college (freshmen, sophomore, junior, and senior) (Corty, 2016).

Two-way ANOVA

Two-way ANOVA examines the effect of two independent variables on a dependent variable but in simple terms. This test consists of two factors, the main effects, which analyze the overall impact of the independent variable and there is interaction effect, which is the effect that one factor (independent variable) has on the other factor. This test is preferable when there is one measurement, such as a quantitative variable with two nominal variables, such as gender. For example, studying the interaction between gender and education level in relation to annual income. The gender (male-1 and female-2) and educational level (high school-1, BS/BA-2, and Masters/PHD-3) are the independent categories and the dependent is the annual income (Corty, 2016).

 

Reference

Corty, E. (2016). Using and interpreting statistics: A practical text for the behavioral, social, and health sciences (3rd ed.). New York, NY: Macmillan Learning.

Respond to the bold paragraph ABOVE by using one of the option below… in APA format with At least two references and a minimum of 200 words….. .(The List of References should not be older than 2016 and should not be included in the word count.)

 

 

 

  • Ask a probing question.
  • Share an insight from having read your colleague’s posting.
  • Offer and support an opinion.

 

 

 

  • Validate an idea with your own experience.
  • Make a suggestion.
  • Expand on your colleague’s posting.

 

 

 

 

 

 

Be sure to support your postings and responses with specific references to the Learning Resources.

It is important that you cover all the topics identified in the assignment. Covering the topic does not mean mentioning the topic BUT presenting an explanation from the context of ethics and the readings for this class

 

To get maximum points you need to follow the requirements listed for this assignments 1) look at the word/page limits 2) review and follow APA rules 3) create subheadings to identify the key sections you are presenting and 4) Free from typographical and sentence construction errors.

REMEMBER IN APA FORMAT JOURNAL TITLES AND VOLUME NUMBERS ARE ITALICIZED.

Unhooking from Thoughts

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Unhooking from Thoughts

Thoughts are a part of everyone’s human experience. However, you do not need to push them away to practice mindfulness. Rather, learning to bring your mind back from thoughts is the practice. This exercise offers a way to “unhook” yourself from those thoughts and simply be with them. Without pushing the thoughts away or denying their presence, you can be aware of the thinking mind while remaining unattached.

STEPS:

    1. Settle into a seated posture and close the eyes. Notice the energy in the mind and body. As you come into a period of mindfulness practice, you may notice the energy of your day resting in the mind and body. The mind may be active, the body may feel worked up, or you right notice a bit of lingering anxiety.
    2. Think of a shaken snow globe, with all that energy swirling around. As you rest, the little snowflakes fall gently to the ground. Think of yourself as a snow globe, and every snowflake as a thought. In this way, watch as each and every snowflake falls to the ground. Do not force yourself to calm down; let it happen slowly and organically.

    3. Unhooking from Thoughts

    4. After a minute or so, bring your attention to the breath in the body. Choose one sport where the breath is felt easily. It may be the center of the chest, the abdomen, the shoulders, or the nostrils. Observe the physical sensation of the body breathing. You may use a counting practice (counting the breaths) if you find it helpful.
    5. Observing the breath for a few minutes, bring the mind back when it wanders. Stick with the snow globe visualization, and as thoughts begin to rise up, observe as they slowly settle back down.
    6. After a couple of minutes focusing on the breath, open your awareness to include your thoughts and your general mental state. Instead of returning to the breath when the mind wanders, notice what the mind is doing. You may notice yourself planning, fantasizing, “figuring out,” or replaying past experiences. Whatever you observe the mind doing, let it be.
    7. When you recognize a thought, what happens? Try not to encourage the thought, but don’t push it away, either. Allow it to be, and allow it to go on its own. See if you can watch the passing of the thought as it follows its natural trajectory and leaves the mind.
    8. Return to the breath and patiently wat until another thought arises. Notice it, watch the thought, and come back to the breath again, Continue with mindfulness of the breath and the thoughts.
    9. Notice when you’re lost in thought or when the mind wanders for some time. If self-judgment arises, notice that just as you would any other thought. You can always return to the breath for a few moments to ground yourself back into the practice.

Reflection:

    • Write a 5-10 sentence reflection on your experience with the Mindfulness Exercise: Finding your breath.
    • Questions to consider:
      • How did you prepare for this exercise?
      • What went well? Did any aspect(s) feel natural or feel easy to you?
      • What did you find challenging?
      • Were you able to recognize and observe your thoughts? What did you find yourself doing…planning, judging, fantasizing…? Were you able to return to the breath?

Medical Job Description of a Healthcare Needs

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Medical Job Description of a Healthcare Needs

Peter R Kongstvedt states, “The case manager is consistently challenged with managing fiscal constraints with patient expectations in light of orders and expectations articulated by the care team. This requires a highly skilled individual, certainly not a job for the faint of heart.” The case manager can also play a role in identifying disease prevention strategies.

In 2 pages, develop a “job description” or job outline for a case manager. Consider disease prevention as part of the responsibilities of the role. Also consider education and skills. Feel free to set up your information in a table. Give your work a professional look, and be sure to include each of the following headings or sections:

  • Facility name
  • Department
  • Position title
  • Classification
  • Position grade or level
  • Shift and/or days of the week
  • Reporting relationships
  • Summary statement
  • Responsibilities
  • Required competencies or position requirements
  • Physical requirements or working conditions
  • Date written
  • Date revised

For information on case managers, see your reading. You may also want to conduct research in the following websites:

Dialysis Time Out Safety Check

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Dialysis Time Out Safety Check

Follow the 3 x 3 rule: minimum three paragraphs, with a minimum of three sentences each paragraph (125 words per paragraph minimum)

Format: APA format according to Publication Manual American Psychological Association (APA) (7th ed.) ISBN: 978-1-4338-3216-1

Format: APA style 7th Edition. Please make sure it is in 7th Edition and if the references have any doi or URL include it.

Minimum of two references, not older than 2015.

I am a nursing student in Florida and hispanic (cuban) in case you need to know for this discussion.

Thank you

Chapter 10: Patient Education and Patient-Centered Care in Professional Nursing Practice. PowerPoint and book attached.

1. One recent change on some nursing units has been the establishment of walking rounds to patient rooms during change of shift report. Using this model, the nurses, patient, and family members (if the patient wishes) are all involved in the exchange of information during the transition of care to the nurse coming on shift. Can you think of any other changes that you have observed in the healthcare setting that help to facilitate a PCC environment?

2. Think about your own life. Do you act to prevent a disease or accident when you perceive that you are not susceptible to the disease or at risk for the accident?

3. Have you ever been assigned to read a book that had so many big words in it that you had to keep the dictionary by your side? If it was assigned for school, you probably struggled through it for the sake of not failing the test, but what about if you were not being graded? Would you bother to read it? If you did read it because you knew it would help you, would you have enough understanding to actually apply the information?

Food-Borne Outbreak

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Food-Borne Outbreak (Case Study #2)

Background

An outbreak (epidemic) of gastroenteritis occurred in Greenport, a suburban neighborhood, on the evening of April 28. A total of 108 people went to the emergency departments of the three

local hospitals during that evening. No more cases were reported afterward. These patients com- plained of headache, fever, nausea, vomiting and diarrhea. The disease was severe enough in 32 patients to require hospitalization for rehydration. Gastroenteritis outbreaks like this are usually caused by the consumption of a contaminated meal. Meal contamination can often be caused by pathogenic viruses or bacteria. However, acute outbreaks are more often produced by toxins from bacteria such as Staphylococcus spp., Clostridium perfringens, Salmonella spp. and Vibrio cholerae. Food poisoning can also be caused by chemicals or heavy metals, such as copper, cadmium or zinc, or by shellfish toxins.

Foodborne Outbreak

Outbreak Investigation

The local health department was notified of a potential food-borne outbreak of gastroenteritis in

Greenport, and the epidemic team, including a medical epidemiologist, a microbiology techni- cian and a nurse, visited the local hospitals to interview the attending physicians, the patients and some of their relatives. Some stool samples were obtained from patients for microbiologic

identification of the causative agent. The epidemic team knew that these types of outbreak usu- ally occur in a very short time period that lasts no more than a few hours or one to two days

after people ingest a contaminated meal.

Epidemic investigators gather data to define the distribution of the disease by time (onset time

and epidemic curve), place (potential places where the implicated meal was served, such as cafe- terias, restaurants and picnics) and person (the distribution of the disease by age, gender and

food items eaten). The findings of the initial investigation included the following information.

Foodborne Outbreak

The distribution of the disease by person (age and gender) was found as follows:

Gastroenteritis Outbreak Findings by Person, Case Distribution

by Age and Gender

Females Males Total
Age Group No. % Female (in age group) No. % Male (in age group) No. %
0-5 1 1
6-10 52 42
11 and older 8 4
Total by Gender

Please calculate the totals for each column and row and their corresponding percentages to try to

determine if there are any important differences by age or by gender. Such a task is carried out to investigate if there are any high-risk groups and if the age and gender distribution can give some clues about the source of the outbreak. Interpret your findings.

 

epidemic curve

The epidemic curve above shows the onset time of illness in the 108 patients involved in the

outbreak. The epidemic team studied the curve and recognized that this was a typical single (point) source acute outbreak. The team also could see that the onset of symptoms in all patients occurred during a six-hour period. Given the symptoms mentioned above and the epidemic curve, the epidemic team concluded that this type of epidemic usually corresponds to intoxication or food poisoning and that the potentially implicated meal was probably served and consumed within a period of a few hours before the onset of the symptoms. Therefore the epidemic team investigated the places where affected persons, their relatives and neighbors ate that day (April 28). The following table shows the team’s findings. Note: Often, during interviews, more ill persons will emerge (who did not seek medical attention and may/may not be part of this outbreak).