Final Exam Review - Introduction Flashcards
Explain the 4 phases of clinical trials.
Phase 1
- Safety
- Small # (<100)
- Healthy subjects
Phase 2
- Efficacy
- Small # (100s)
- In patients w/ disease
- Compare to placebo or current drug
Phase 3
- Larger and longer
- Possibly >10000 participants
- Randomized, double blind
Phase 4
-Post marketing
What is the difference between off-label and off-patent?
- Off-label is using a drug for something originally not approved for.
- Off patent is when anyone can make the drug without paying the developer
What is controlled substance and what are the classifications?
Classifies a drug as being abusable.
Classified into Schedule 1 to 5, with 1 having the most abuse potential with no medical usage. Class 5 has a med usage with low abuse potential
What is the acronym ADME and explain each.
- Absorption- Can be enteral (GI tract) or parenteral (non GI tract)
- Distribution- Distribution through the body. Measured as Vd, higher Vd means there is more drug in tissue than blood.
- Metabolism- How a drug is inactivated and prepared for elimination. Involves CYP enzymes.
- Excretion- How the drug leaves the body.
What is the difference between first order and zero order elimination?
Firsts Order:
- Eliimination is proportional to concentration
- 10 to 5 to 2.5 to 1.25
Zero Order:
- Constant elimination rate
- 10 to 7.5 to 5 to 2.5
How many half lives does it take for a drug to be considered “cleared”?
5
What is the difference between specificity and selectivity?
Selective is associated with subtypes of a receptor while specificity is just the receptors.
-Selective is more selective than specificity.
What are the subtypes of agonists and antagonists?
- Competitive antagonist
- Noncompetitive antagonist
- Partial agonist
What is the difference between the competitive and noncompetitive antagonists?
Competitive will compete with the agonists while noncompetitive bind to a separate site, meaning its irreversible.
What is a partial agonist?
A partial drug agonist will take up a slot but gives a lower effect than if there were a perfect fit drug.
Is a drug with a lower ED50 more or less potent? Why?
Lower, there is a lower dose reuired to get to 50% of expected response
Does a NTI drug have a lower or higher chance of AE and toxicity?
What is the formula for TI?
- Higher
- TD50/ED50
A DDI can result in either a _________ or _________ reaction.
- synergestsic
- antagonistic
What are the other 2 types of drug interactions that may occur?
- drug-food interactions
- drug allergies
What can cause increased risk for ADRs?
- Age
- Genetic variations
- Disease states
- DDI
- HCP error
- Nonadherance