Drug evaluation Flashcards
1
Q
Describe the structure of phase 0-IV clinical trials.
A
- Patent filing
- Pre-clinical work-up
- Phase 0 studies
- Phase I clinical studies
- Phase II clinical studies
- Phase III clinical studies
- Product registration
- Product launch
- Phase IV studies
2
Q
What is phase 0 studies?
A
- Micro-dosing studies. Have no biological effect. Designed to assess pharmacokinetics & pharmacodynamics. Small number of volunteers.
3
Q
What is Phase I clinical studies?
A
- Healthy, paid male volunteers. Assess for tolerability, pharmacokinetics, pharmacodynamics, metabolism, potency.
4
Q
What is Phase II clinical studies?
A
- Therapeutic exploratory. Patients recruited with appropriate disease.
- Phase IIa (repeat phase 1) and phase IIb ( monitors surrogate endpoint.
5
Q
What is Phase III clinical studies?
A
- Therapeutic confirmatory. Large patient population to establish efficacy and safety.
- Dose-response and benefit-risk relationship.
6
Q
What is Product registration?
A
- Dossier is prepared and used to support registration of the drug. Emphasis is on safety and efficacy.
7
Q
What is phase IV Studies?
A
- Studies on an approved drug. Post-marketing studies to refine benefit/risk. Comparative.
- Adverse effects: Low incidence and in long-term use.
- Pharmacoeconomics.
8
Q
Describe the basic principle of pharmacoeconomics.
A
Depends on:
1. How much the drug costs
2. The duration of treatment
3. The cost of other medications
4. Cost of not treating
5. How many patients have the disease
6. What percentage benefit from the disease – What type of benefit
* Can be subject to political and financial pressures
9
Q
What is QALY?
A
- Quality adjusted Life Years.
- A key pharmacoeconomic measure.
10
Q
Discuss the commercial aspects of drug development.
A
- Drug has to be made for study
- Requires a registered Good Manufacturing Process (GMP) facility
- Detailed batch analysis is required
- Requires clinical trials and people to conduct studies on.
