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10 Cards in this Set
- Front
- Back
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What is the cost (years/$) of bringing one new drug to the public?
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$1.8-2 billion; 10-12 years
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What are the key steps to drug discovery and years spent on them?
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1. Research & Development - 2 - 3 yrs
2. Pre-clinical testing - 1 yr 3. Clinical trial testing - 10 yrs 4. Regulatory approval - 2 yrs |
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What is the purpose of therapeutic efficacy?
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- increase activity against the chosen target
- reduce activity against unrelated targets - improve the "drug-like" or ADME properties |
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What do the chemical manufacturing controls/pharmaceuticals do?
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The results of preclinical testing are used by experts in pharmaceutical methods to determine how to best formulate the drug for its intended clinical use.
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What does pharmacological testing do?
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determines effects of the candidate drug on the body
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Phase 1 clinical studies
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- 200-100 healthy volunteers
- test for safety, dosage, and ADME - 6 months - 1 yr |
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Phase 2 clinical studies
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- 100-500 patient volunteers
- evaluate effectiveness, look for side effects - 2 years - groups: new drug, placebo, current standard |
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Phase 3 clinical studies
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- 1-4 years
- 1000 - 5000 patient volunteers - confirm effectiveness, monitor long-term reactions |
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Phase 3b/4 clinical studies
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- follow-up for post-approval
- maybe problems with sub-group of people |
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Post-Market studies
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- look at new age groups/patient types
- other possible side effects |
