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13 Cards in this Set
- Front
- Back
3 phases of drug life cycle
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1.) discovery
2.) development 3.) commercial |
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The stages of discovery (4)
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Targets and leads
1.) Target identification 2.) Target validation 3.) Lead generation 4.) lead optimization all of these stages of discovery become a clinical candidate of discovery |
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Target ID:
a.) Where do they come from? (3) b.) main point |
1.) animal and cell experiments, opportunistic observations, genomics
2.) find the protein that causes the disease |
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Systems biology
a.) definition |
a.) using genomics and proteomics for target identification
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Target validation
a.) example |
knockout genes, association genes
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CGH array
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comparing 2 genomes (gene validation) via amplification and deletion
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Gene expression array
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comparing 2 genomes (gene validation) via upregulation/ downregulation
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Lead generation
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Screening for drug leads, aka molecules that interact with the drug target
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Lead optimization
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testing for safety (most intensive step)
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Phase I
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oncology: For refractory patients
normal: volunteers |
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FIH
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First in human study: Phase I clinical trial
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Phase II
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Efficacy: dose
normal: based on disease oncology: based on phase I |
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Phase III
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Safety and efficacy
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