Flashcards in Drug Development Deck (31)
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1
What are the four main stages of drug development?
drug discovery, preclinical development, clinical development, regulatory review
2
Stages of drug discovery
target selection, lead finding, lead optimisation
3
targets for drugs
enzymes, transport proteins and receptors
4
First step of target selection
target identification
5
What does target identification involves
coupling genomic data with disease mechanisms and signalling pathways
6
What limits innovation of drugs
poor target selection, unforeseen side effects
7
What are lead compounds derived from
synthetic chemistry
8
What helps find the lead compound
cloning and expression of target protein
9
Why is cloning and expression of the target protein done in human form
variations between species can lead to pharmacological differences
10
What techniques does lead finding use?
assays
11
What do assays in lead finding measure
functional activity of the target protein
12
What do lead finding assays require
large compound libraries
13
How are the large compound libraries made
combinatorial chemistry
14
What techniques are used to gain knowledge about the target
molecular modelling and X-ray crystallography
15
What are undesirable characteristics of a drug
large molecular weight, large polarity, toxicity
16
What eliminates undesirable drugs
computational screening of compound libraries
17
What are the aims of lead optimisation
increase potency, optimise selectivity and pharmacokinetic properties
18
What do assays at the stage of lead optimisation measure
activity and time course
19
What are the four main catergories of preclinical development
pharmacological, preliminary toxicological, pharmacokinetic testings
20
What do tests during preclinical development check for
side effects, absorption, maximum non-toxic dose,
21
What does preclinical development stage have to conform to
good labrotory practice
22
What does phase I of clinical trials check for
dangerous side effects and pharmacokinetic properties
23
What dose clinical trial phase II determine
beneficial pharmacodynamic effects
24
What does clinical trial phase III involve
randomised trials of drug versus a placebo
25
What does clinical trial phase IV involve
detection of unwanted long term adverse effects
26
How are biopharmaceuticals produced
biotechnology
27
What is an advantage of biopharmaceutical versus convential synthetic compounds
they have less toxicological problems
28
What are the disadvantages of biopharmaceuticals versus conventional drugs
more problems relating to production, quality control, immunogenicity and delivery
29
What can biopharmaceuticals be used to treat?
cancer
30
