Drug Development Flashcards
(30 cards)
Which organization approves a drug?
FDA
What is the difference between phase one, two, three, and four for a new drug?
Phase one-smaller sample size, and tested on healthy individuals
Phase two–medium sample size, introducing those with the disease
Phase three–large sample size, testing those with the disease.
Phase four–manufacturing of the drug and FAERS.
What is a new drug?
A drug that has not been approved by the FDA
What is the process of a new drug development?
The drug is developed (can take anywhere from 2-10 years), then the preclinical research and development take place (3-6 years), then an investigation new drug (IND) is submitted. If there is no work back after 30 days, you know you can begin clinical trials (there is no “approval letter”. Then the three phases of the clinical trial take place (6-7 years) and then a new drug application is submitted (NDA). FDA reviews it and gives one of three types of letters. If it is approved, the manufacturing begins and FAERS is monitored.
What are the three main ways of drug discovery?
Serendipity–accidental discovery (ex: viagra for ED)
Target-centered–drug was created to hit a specific target
Compound-centered–when we discover a compound that was tested on biological targets (typically receptors).
What is lead optimization?
That the drug and the receptor will be a perfect match for what you want to happen
Do you need approval for preclinical investigation of a drug?
No, as long as you have the money and equipment to fund the research yourself.
What is the gold standard of clinical trials?
Double blind, randomization, controlled trial
Does the FDA approve an IND? When can you continue trials?
No, after 30 days if you do not get a rejection
What is the drug called during clinical investigation?
Investigational drugs–needs to test for adverse effects with food, drinks, etc.
What are the three types of comparison designs in a clinical trial?
Superiority–compare to a placebo
nonInferiority–makes sure the drug is not inferior to a similar one already made.
Equivalence–seeing if one drug is statistically the same effectiveness as another.
What are two different types of efficacy data?
Continuous–interval, mean difference, ration
Dichotomous– only two categories (ex: male vs female, yes or no, etc).
What are the three kinds of letters that the FDA will provide in their action letter?
Approval letter, you are good to go
Approvable letter, needs some work but is alright
Nonapprovable letter-so bad, concerned!!!
What is the purpose of a fast track trial?
To fill a medical necessity, ex: Covid
What does accelerated approval mean for a drug?
That the application will be reviewed sooner than normal. Typically for a medical necessity. Typically how fast track trials will be approved.
What is FAERS and what is their purpose?
FDA adverse event reporting system–follow up after the drug is manufactured, looking for new patient safety concerns.
What does open label mean?
The patient knows what they are taking.
What are orphan drugs?
Drugs that are used to treat rare diseases. Government offers grants for these as you do not make money off of them.
What are the OTC regulations by the FDA?
They need to be considered GRASE and their safety margin is large.
How does the FDA initially categorize potential OTC drugs?
Category I: considered GRASE
Category II: not considered GRASE
Category III: cannot determine safety and effectiveness
What are biologics?
Things taken from living organisms that are used in drugs/products (ex: vaccines)
What devices must the FDA regulate?
Any device with therapeutic claims (ex: toothbrush, LVAD, etc)
What are the specifications of each class of recall for drugs and devices?
Class I–product is harmful
Class II-product causes more damage to individual
Class III–they do not have an effect at all.
What must each new generic drug (ANDA) demonstrate when creating a similar drug when the 20 year patent has ended?
BIOEQUIVALENCE–it does the same thing as the brand name drug (a 20% variation is acceptable).
