Endpoints Research Papers Samples For Students

Drug Development Slides

What are some of the major responsibilities of the US Food and Drug Administration?
The FDA is responsible for protecting public security by ensuring all foods sold meet hygiene and safety standards.
How long does the drug patent usually last? Can you gain an extension?
The drug patent lasts for 17 years and one can get a patent if they apply.
What are the basic sections of a US IND?
- Toxicology and effectiveness during pre-clinic trials
- Clinical work that will be carried out in Phase 1 and 2
- Manufacturing and chemistry ...

WHI Trial (Writing Group for the WHI Investigators; JAMA)

What was the main objective of the WHI study?
Assesment of the most commonly used combined hormone preparation in the US for health benefits and risks
When and why was the subject enrollmentstopped early (specific statistical reason)?
After 5.2 years. This was due to harm from the breast cancer.

What was the design of the trial?

16608 postmenopausal women underwent the study over 8.5 years

Who monitored the “double-blind” data? How often?

Safety monitoring board.Monitored semiannually.

How many women: screened, randomized, assigned to either arm?

373092 – Screened, 16606 – Randomized, 8506 – Estrogen, 8102- Placebo
Why was the dose of E 0.625 mg/day and P 2.5 mg/day in a single tablet chosen?

Highest amount without damaging the subjects

Why was an “intact uterus” necessary for entry ...

Black holes are space zones in the universe that are dark in nature and possess natural forces of attraction that have a very high gravity. This implies that they are able to attract and pull anything including light at a very high speed. This explains the origin of the name, Black hole. Several myths have been generated in many attempts to try and explain what a black hole is and Hollywood is at the forefront of it. Movies from Hollywood portray black holes as time physical entrances to tunnels that if one goes through, he can either move back or fourth in ...