finals AAAAAAAAAAAAAAAAAAAAAAA Flashcards
(242 cards)
How many years for preclinical testing, what is the test population, purpose and success rate
6.5 years, lab and animal studies to assess safety, biological activity and formulations. 5000 compounds evaluated
How many years for phase 1, what is the test population, purpose
1.5 years, 20 to 100 healthy volunteers to determine safety and dosage
How many years for phase 2, what is the test population, purpose
100 to 500 patient volunteers to evaluate effectiveness and look for side effects
How many years for phase 3, what is the test population, purpose
1000 to 5000 patient volunteers to confirm effectiveness, monitor adverse reactions from long term use, to compare efficacy of new treatment with standard regimen
When do you need to get FDA approval
After preclinical and after phase 3
How long does it take for the FDA to finally approve and how many drugs make it (out of how many)
1.5 years after phase 3. it takes a total of 15 years and only one drug is approved from the 5 that enter clinical trials
Why do cancer cells reproduce infinitely
Growth machinery is activated or stop machinery is gone. This is often a genetic change, with the DNA being different from healthy cells
What kind of mutations are passed on
inherited but not acquired mutations, because acquired or somatic mutations are not in the egg or sperm cells
What mutations cause cancer
acquired lol, i’m going to die because of my constant exposure to chemicals and possible carcinogens due to cosplay
What is the newer type of cancer drugs
Targeted therapy
What are the two components of human immune system
Innate and acquired immunity
What do t cells do
They are a type of immune cell that bind foreign peptides to kill cancer cells
What do b cells do
They have the ability to create antibodies, which kill cancer
How does cancer evade our immune systems
Cancer can turn off immune cells, change the healthy cells in tissue around tumor, and alters how immune system deals with cancer cell
What is immunotherapy
A therapy that helps our immune system overcome the ways cancer evades it
How did deidra williams get cured in first in human
first remove own hemotopoietic stem cells by chemo then deliver family member’s stem cells
How many drugs are marketed in north america
1000
How many prescriptions per year in the US
3.4 billion
How many hospital visits need drug therapy
75%
What does the who list of essential medicines take into account
how common the disease is, how serious is the disease, public health, community health, efficacy, cost effectiveness
What is a drug target
a molecule that the drug binds to that deactivates the molecule, usually a protein. It needs to bind specifically.
How many animal species to test on in drug discovery
2
In what cases do you have patients in phase 1
Cancer patients
When is pharmokinetics investigated
phase 1