FDA's Drug Review Process Flashcards
often, a drug is developed to do what?
treat a specific disease
drugs can also be discovered….
by accident
give an example of a drug whose purpose was discovered “on accident”
retrovir was first studied as an anticancer drug with no success.
twenty years later, researchers discovered that it could treat AIDS
preclinical testing is also known as ___ testing
animal
true or false
most drugs that undergo preclinical testing never even make it to human testing and review by the FDA
true
before submitting an IND, the pharmaceutical company may seek advice from whom?
the FDA
Explain what happens at the submission of an IND
the sponsor (company, research institution, or other organization that takes responsibility for developing a drug) must show the FDA results of preclinical testing in lab animals AND propose what they plan to do for human testing
drug studies in humans (clinical trials) can only begin when?
after an IND is reviewed by both the FDA and an IRB (localized institutional review board)
is is the “local institutional review board” that reviews an IND along with the FDA?
a panel of scientists and non scientists in hospitals and research institutions.
they oversee clinical research
who approves the clinical trial protocols?
IRBs
what do the clinical trial protocols explain?
-type of people who can participate
-schedule of tests and procedures
-medications and dosages to be studied
-length of study
-objectives of study
_____ ensures that the proposed clinical trial is acceptable, that the participants have given consent and are fully informed of the risks, and that the researchers take appropriate steps to protect the patient from harm
IRBs
phase 1 studies are conducted in what kind of volunteers? how many?
what is the purpose of phase 1?
HEALTHY volunteers 20-80 of them
goal: determine what the drug’s most frequent side effects are, how the drug is metabolized and excrete
phase 2 studies only begin if……..
phase 1 studies don’t reveal unacceptable toxicity
the emphasis of phase 1 is on ___ while the emphasis of phase 2 is on _____
phase 1 = safety
phase 2 = efficacy
phase 2 aims to obtain preliminary data on what?
whether the drug works in people who HAVE the disease or condition
phase 2 is conducted on what 2 groups?
-patients with the condition receiving the experimental drug
-patients with the condition who are receiving a different treatment — either a placebo or a different real drug
how many subjects are typically in phase 2 clinical trials?
few dozen - 300
what happens at the end of phase 2?
FDA and sponsors come up with an agreement on how large-scale studies in phase 3 should be done
name the 2 common meeting points of the sponsor with the FDA
-before submitting an IND
-after phase 2 to discuss phase 3
phase 3 studies only begin if…….
evidence of effectiveness is shown in phase 2
explain what is happening in phase 3 and how many subjects there are
gather more info about safety and effectiveness
studies DIFFERENT POPULATIONS, DOSAGES, AND USING THE DRUG IN COMBO WITH OTHER DRUGS
number of subjects ~3000
what is the “formal step” a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United States?
NDA (new drug application)
when an NDA is submitted, the FDA has how long to decide whether to file it so it can be reviewed?
what would be a reason to NOT file it
60 days
if the application is incomplete (ex – required studies missing)
