Module 9 Therapeutic Index Flashcards
1
Q
Interpatient Response Variability
A
- Response to medication unique
- Evaluation ensure therapeutic response
2
Q
Medication Response Influences
A
- Genetics
- Disease state
- Environment
3
Q
Determining Interpatient Variability
A
- Clinical trails
- Setting an end point
4
Q
Phase 1
A
- 20 - 100 volunteers
- Animal studies guide dosing
- Evaluate pharmacokinetics & pharmacodynamics
5
Q
Phase 2
A
- 300-500 with disorder
- Determine dose-response over range of doses
- Short term trial
- Efficacy & side effects
6
Q
Phase 3
A
- 500-5000 with disorder
- Verify efficacy
- Evaluate long term side effects
7
Q
Phase 4
A
- Post-marketing surveillance
8
Q
Data Collection
A
- Plot on frequency distribution curve
- Average effective dose (ED50)
- Peak of curve
9
Q
ED50
A
- Required dose to produce response 50% of people
- Used as initial dose in therapy
10
Q
ED50 Wide Range
A
- Use ED50 measurement for initial dose
- Monitor patient response
11
Q
ED50 Narrow Range
A
- Titrate dose ED50 dose
- Start low & increase until response achieved
12
Q
Dosing Implications
A
- Dose adjustments from ED50 for effective therapy
- Patient response
13
Q
Toxic Doses TD50
A
- Animals used for testing
- Short term & chronic
- 50% of tested animals experience toxicity
- Drug/kg of body weight
14
Q
Lethal Doses LD50
A
- 50% of tested animals experience death
- Drug/kg of body weight
15
Q
Therapeutic Index
A
- Indicator of drug safety
- Ratio of LD50/TD50 to ED50 (division)
