Final Exam : 22 Flashcards
What is a pre-clinical trial?
Testing of a new drug is done by a cell culture and animals in order to gain more information.
What is phase I?
This study is done to determine a safe dose and uses a small group of people
What is Phase II?
Preliminary testing is done in this trial using a group of about 100 to 500 people.
Describe Phase III?
Uses a larger group of people to determine if drug increases patient survival.
Describe IV?
Continued drug evaluation after approval; FDA approves after 1000-5000 people have been exposed to the drug for 4 to 5 years
What is the significance of Randomized Controlled trials?
it is used to determine if the therapeutic benefit of a new drug is measurably greater than existing treatments
How are trials controlled?
Patients are divided into groups. One receives the new drug or treatment while the other doesn’t (a placebo)
What is double - blinding?
The doctors AND the patients don’t know who is receiving the drug and who is receiving the control treatment
What could be the outcome if there wasn’t randomization and double - blinding?
The patient could have the placebo effect, while the doctors could have the experimenter bias in interpreting the results
What are some of the issues of the drug development system?
- Cost is too high
- Problems with Genetic Diversity
- Over regulation of safety > risk
- It takes far too long
Pharmacology:
science of drugs and how they work in the body
Pharmacokinetics:
What the body does to the drug; how it clears it from the bloodstream
Pharmacodynamics:
What the drug does to the body
What is the therapeutic window?
The range of drug doses that can be used clinically; ranges from the minimum therapeutic does to the maximum tolerated dose
Why was gleevec so successful?
CML is caused by a single genetic defect that is present in 95% of its patients and it does not exhibit the genetic diversity seen in most cancer patient
