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13 Cards in this Set

  • Front
  • Back
3 phases of drug life cycle
1.) discovery
2.) development
3.) commercial
The stages of discovery (4)
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
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
Systems biology
a.) definition
a.) using genomics and proteomics for target identification
Target validation
a.) example
knockout genes, association genes
CGH array
comparing 2 genomes (gene validation) via amplification and deletion
Gene expression array
comparing 2 genomes (gene validation) via upregulation/ downregulation
Lead generation
Screening for drug leads, aka molecules that interact with the drug target
Lead optimization
testing for safety (most intensive step)
Phase I
oncology: For refractory patients
normal: volunteers
FIH
First in human study: Phase I clinical trial
Phase II
Efficacy: dose
normal: based on disease
oncology: based on phase I
Phase III
Safety and efficacy