Drug Approval - Sweatman Flashcards
What are Herg Channels?
Potassium channels in polarized membranes. Must check for interactions with this because if it is altered, cardiac arthymias can result. It is tested for this before it ever comes to clinical trials.
What type of testing must occur immediately before trial testing?
toxicity testing, which can take 2-6 years.
What is the IRB?
Institutional Review Board. they must approve trials of drugs
What are Phase I clinical trials?
Essentially a process to define Maximum Tolerable Dose. Usually done in paid volunteers, except in the case of cancer drugs, in which case it is done in patients who have failed all other treatments.
What are Phase II trials?
More expensive, more patients and explores and refines the optimal dosing regimen and dose pharmacokinetic relationship. Tested on patients who have the disease which is being treated.
What are Phase III trials?
Testing to see if the benefits will outweigh the risks. Often conducted in a blind or double-blind fashion.
What are pharmacometrics?
simultaneous quantitative understanding of drug dose or exposure and response to measure evidence of effectiveness, dose optimization.
Why are generic drugs cheaper?
They do not need to undergo Phase 1-3 clinical trials. They only need to undergo bioequivalence tests, which are cheap.
What is Phase IV?
Post-marketing review of recently released drug toxicities and adverse effects.
What is the strongest warning the FDA can require on a marketed drug?
Black box warning
Can doctors prescribe drugs for uses other than what they are approved for?
Yes. This is called off-label prescription. However, drug companies cannot advertise for any use not approved.
How was the off-label marketing law bypassed?
Supreme court ruling said that drug reps who were charged with crime of off-label marketing to doctors were unconstitutionally charged because it infringed upon their right to free speech.
Why is off-label marketing dangerous, even if it’s done to doctors?
There are little to no requirements for testing of off-label use and doctors often do not have the time to look up the literature to verify the truth of what they are told by drug reps. In some cases this has lead to inadvertent deaths and complications
