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5 Cards in this Set
- Front
- Back
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What is the drug development timeline? |
1. NME - new molecular entity / Basic research [1~2 yrs] 2. Preclinical studies (on animals) [~3yrs] 3. Clinical testing. Phase 1, 2, 3 - very costly [~5yrs] 4. Prelaunch activities [~2yrs] 5. Launch 6. Post-marketing studies (phase 4)
In total it can take about 10~12 yrs and +$800M US |
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During drug development stages when are regulatory reviews done, and by whom? |
Before and after clinical testing. Done by regulatory authorities like the FDA. |
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What are the 6 major methods that drugs are discovered by? |
1. Herbal/traditional remedies 2. Empirical approach 3. Rational drug design 4. Pro-drugs/analogues/metabolites of existing drugs 5. Serendipity 6. Genomics |
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Describe empirical approach of drug discovery |
It's about screening through libraries of thousands of drugs and molecular compounds then choosing something that could possibly give beneficial effects |
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Describe rational drug design of drug discovery |
Understanding the biochemical nature of the disease and rationally designing a drug to target that - such as using 3D models. |
