Drug discovery and clinical trials

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  • Created by: Rscottqub
  • Created on: 10-03-19 12:25
what are the main steps in the discovery process
pre discovery, target ID, target validation, drug discovery, early safety tests, lead optimization
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pre discovery
research is done regarding the disease- need to understand the disease and its cause
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Target ID
a molecule is identified which is involved in the disease
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target vailidation
the role of the target is confirmed. checking the target influences the progression of the disease. This is a crucial step to ensure projects do not lead to dead ends and money wastage
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Drug discovery
search for drug which will act on the target.
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Early safety tests
tests carried out on cells and animals to test ADME
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Lead optimization
Lead drug candidates are altered slightly to improve properties
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Pre clinical trials
carried out on animals to ensure safe for human testing
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Main steps in clinical trails
IND. Phase 1 . Phase 2. Phase 3. NDA. Manufacturing. Phase 4
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why carry out clinical trials?
safe in humans. produce stats. prove a claim
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IND
investigation new drug application to FDA- must include information fro pre clinical trails - including tests and research
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Phase 1 trials
small number of healthy volunteers - test is safe in humans
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Phase 2
small number of patients
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Phase 3
large number of patients. test for side effects . produce stat. longest and most costliest trial
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NDA
new drug application to FDA- they can do 1 of 3 things : 1. accept 2. reject. 3. ask for more info
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Manufacturing
construct facility to manufacture your product
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Phase 4
continued research and tests- any adverse - reported to FDA
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Card 2

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pre discovery

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research is done regarding the disease- need to understand the disease and its cause

Card 3

Front

Target ID

Back

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Card 4

Front

target vailidation

Back

Preview of the front of card 4

Card 5

Front

Drug discovery

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