ASSIGNMENT 3 (1)
pdf
keyboard_arrow_up
School
Rutgers University *
*We aren’t endorsed by this school
Course
01:119:150
Subject
Medicine
Date
Jan 9, 2024
Type
Pages
3
Uploaded by KidSnowAlbatross25
1. What does the FDA do? What does the FDA regulate? You do not have to provide me with
full list, a summary will be fine.
The FDA is known as the Food and Drug Administration. They are responsible for
protecting public health by ensuring the security, efficacy, and safety of pharmaceuticals
for humans and animals, biological products, and medical equipment. The FDA also
takes care of the security of our country's food supply, cosmetics, and radiation-emitting
items.
2. One of the things the FDA regulates is drugs. Briefly describe the drug approval process.
Make sure to define Phase I, II, III, and IV clinical trials and informed consent in your
description.
The drug approval process is very extensive and all drugs must go through a rigorous
evaluation process which is made to dissect and understand every aspect of the drug. The
drug goes through both preclinical (animal) testing and then to human testing, but for
human testing to occur the FDA and the local institutional review board (IRB) must
review the IND application. Once this is done phase one can begin. Phase one is
conducted on 20-80 healthy volunteers and the studies are used to determine the drug's
most frequent side effects and how the drug is metabolized and passed through the body.
Phase two testing can only begin if the drug passes phase by being under the accepted
toxicity levels. Phase two’s main focus is on how effective the drug is on people who
have the disease/condition. This phase involves the use of a blind experiment that
involves a placebo or different drug. At the end of phase two the FAD and the sponsors
meet and the studies are used to gather more information about the drug's safety and
effectiveness. They test the drug on different populations and test what the drug does
when combined with other drugs and used at different dosages. Phase four involves a
review meeting between the FDA and the drug’s sponsor. Once the FDA has concluded
that the product is good enough to be put on the market, they complete postmarket
requirements and commitment studies to ensure the product's safety. The New Drug
Application is what the drugs sponsor submits to the FAD as a final approval to put the
drug on the market. The NDA encompasses all the relevant information that was found
during phases one to three.
3. Then search the Clinical Trials website for a trial of the use of Paxlovid to treat long COVID.
Use the "Find a Study" box and type in "long COVID19" in the "Disease or Condition" and then
"Paxlovid" in the "Other Terms" box and then click "Search". This will bring to you a screen
with two studies, click on the first and answer the following questions:
●
What is the purpose of the study?
The study is to improve treatment plans of long COVID in the health care system and in
different communities.
●
Briefly describe the study design.
The study involved 1700 randomized participants that were chosen after completing an
array of symptom questions. The participants were assigned into one or more out of three
Symptom Clusters that were based on the original assessment. Once they are assigned
into their cluster they will then be assessed again, if they qualify for more screening they
will undergo assessment of all the symptom clusters that the participant qualifies for.
●
What are the primary outcomes?
The primary outcomes that were found include a change in exercise intolerance, a change
in cognitive dysfunction, and a change in autonomic dysfunction.
●
What are the eligibility requirements?
In order to be eligible for the study the individuals must be older than 18, had been
previously suspected or confirmed to have the SARS-CoV-2 infection, show signs of the
clinical or epidemiological criteria (fever, cough, weakness, headache etc.), have at least
one moderate cluster-associated symptom, must meet the patient reported outcome
symptom cluster criteria, and must be willing and able to provide informed consent to
complete the surveys provided and attended the necessary follow-up visits
“SARS COV-2 Viral Persistence Study (PASC) - Study of Long Covid-19 - Full Text View.”
SARS CoV-2 Viral Persistence Study (PASC) - Study of Long COVID-19 - Full Text View -
ClinicalTrials.gov
,
https://clinicaltrials.gov/ct2/show/NCT05595369?term=Paxlovid&cond=long%2BCOVID
19&draw=2&rank=1#outcomemeasures
.
4. Finally, use the RU Libraries website https://www.libraries.rutgers.edu and one of the
database search engines for finding articles, e.g. MEDLINE, find one scientific research article
having to do with treatment of COVID19. (If you decide to use MEDLINE, I would suggest you
search for COVID19 and then on the next screen, the "Combine Screen", check "Drug
Therapy".) Remember that a scientific research article (primary source), must have a Methods
section describing the research the authors did and a Results section describing the data they
collected. Please provide me with the full citation (using the format described in the final paper
document) and a short (1-2 sentence) summary of the research study.
The purpose of this experiment was to find out what influence the COVID-19 pandemic had on
the perioperative course in cholecystectomy patients and to call attention to the possible residual
consequences.
Fischer, L., et al. “[The COVID-19 Pandemic Had Significant Impact on Duration of Surgery
and Hospitalization Time for Patients after Cholecystectomy].”
Chirurgie (Heidelberg,
Germany)
, vol. 94, no. 1, Jan. 2023, pp. 61–66.
EBSCOhost
,
https://doi.org/10.1007/s00104-022-01788-4.
Your preview ends here
Eager to read complete document? Join bartleby learn and gain access to the full version
- Access to all documents
- Unlimited textbook solutions
- 24/7 expert homework help