Term
| Steps in Drug Approval Process |
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Definition
1) Preclinical studies
2) Clinical trial Application
3) Clinical Trials (phases 1,2, & 3)
4) New Drug submission (NDS)
5) Submission Review
6) Market Authorization (by NOC to Health canada)
7) Price Review (by PMPRB)
8) Public Access, Prescribing practices, real-world use studies (phase IV), therapeutic cost effectiveness. |
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Term
Preclinical research
How long does it take?
Patients involved?
Purpose? |
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Definition
Preclinical research
How long does it take - 18 months to 3 years
Patients involved - NONE
Purpose - Lab investigation for efficacy and toxicity |
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Term
Phase I
How long does it take?
Patients involved?
Purpose? |
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Definition
Phase I
How long does it take - 2 years
Patients involved - 20 to 100 patients
Purpose - Safety and dosage
Phase I --> Patients not required to have dx, just doing it for safety and dosage |
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Term
Phase II
How long does it take?
Patients involved?
Purpose? |
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Definition
Phase II
How long does it take - months to 2 years
Patients involved 100-300 patients
Purpose - Efficacy, some safety
Phase I --> Patients not required to have dx, just doing it for safety and dosage
Phase II - Patients WILL have dx, because purpose is mainly efficacy, also some safety |
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Term
Phase III
How long does it take?
Patients involved?
Purpose? |
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Definition
Phase III
How long does it take 2-3 years
Patients involved - 100 to 3000 pts
Purpose - relative efficacy (vs. gold standard), test on dx patients.
Drug can be sold in Market after Phase III, and approval |
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Term
Phase IV
When is it conducted? |
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Definition
Phase IV
When is it conducted - After approval and drug has been in the market. |
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