Lecture 2 - Sources of drugs and their nature Flashcards
Drug discovery process step 1
basic research in universities
Drug discovery process step 2
identification of potential drug targets
Drug discovery process step 3
hypothesis generated
Considerations during drug development process [4]
- safety issues
- ethical issues
- intellectual property
- cost
how long is pre clinical development in clinical trials
5-10 years
how long does new patent for drug last
20 years
clinical trial - Phase I name
exploratory: first in human
Phase I - what is assessed
- chronic toxicity pf drug
- tested in 2 mammalians [1 non-rodent]
Phase I - how long does it last
6 months - 1 years
Phase I - purpose [2]
- safety
2. tolerability
Clinical trial - Phase II name
Efficacy, proof of concept + safety
Phase II - purpose [2]
- determine how clinically effective drug is
- confirm safety + tolerability
Phase II A - name
exploratory
Phase II A - number of patients
50-200 patients
Phase II A - how long
1 year
Phase II A - design [3]
- placebo - controlled
- randomised
- double- blind
Phase II A - method
optimise dose and treatment regime based on Phase I
Phase II B - name
confirmatory
Phase II B - number of patients
200-500 patients
Phase II B - method
safety and efficacy compared to placebo or treatment
Phase II A - design
- randomised
2. double - bind
Phase III - name
confirmatory
Phase III - purpose
see effectiveness and safety pf treatment compared to standard/ placebo
Phase III - number of patients
2000- 10 000 patients
Phase III - goal
provide data to support registration for specialised use
Phase III - how long
several years
Phase IV - name
clinical trials [ongoing]
Phase IV - purpose [2]
- designed to monitor consequences of increasing exposure in 10 000 patients
- yield information on drugs efficacy in sub-groups
Structure Activity Relationship [SARs]
structure of drug can be manipulated by looking at activity it produces
Chemical Library
contain millions of chemical compounds, each a potential molecule
What process can the library be boosted by?
combinatorial chemistry
What is combinatorial chemistry?
synthesis method to prepare large number if compounds in single process
How to identify which compound in library has required biological activity?
High throughput screening
What is High throughput screening?
mechanism by which you can test many compounds to see effectiveness
What does High throughput screening involve?
involves using more complex assay techniques that are able to identify potential drugs
Look at Drug Discovery Diagram
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