Drug Development

Question 1

What are the four main stages of drug development?

Answer 1

drug discovery, preclinical development, clinical development, regulatory review

Question 2

Stages of drug discovery

Answer 2

target selection, lead finding, lead optimisation

Question 3

targets for drugs

Answer 3

enzymes, transport proteins and receptors

Question 4

First step of target selection

Answer 4

target identification

Question 5

What does target identification involves

Answer 5

coupling genomic data with disease mechanisms and signalling pathways

Question 6

What limits innovation of drugs

Answer 6

poor target selection, unforeseen side effects

Question 7

What are lead compounds derived from

Answer 7

synthetic chemistry

Question 8

What helps find the lead compound

Answer 8

cloning and expression of target protein

Question 9

Why is cloning and expression of the target protein done in human form

Answer 9

variations between species can lead to pharmacological differences

Question 10

What techniques does lead finding use?

Answer 10

assays

Question 11

What do assays in lead finding measure

Answer 11

functional activity of the target protein

Question 12

What do lead finding assays require

Answer 12

large compound libraries

Question 13

How are the large compound libraries made

Answer 13

combinatorial chemistry

Question 14

What techniques are used to gain knowledge about the target

Answer 14

molecular modelling and X-ray crystallography

Question 15

What are undesirable characteristics of a drug

Answer 15

large molecular weight, large polarity, toxicity

Question 16

What eliminates undesirable drugs

Answer 16

computational screening of compound libraries

Question 17

What are the aims of lead optimisation

Answer 17

increase potency, optimise selectivity and pharmacokinetic properties

Question 18

What do assays at the stage of lead optimisation measure

Answer 18

activity and time course

Question 19

What are the four main catergories of preclinical development

Answer 19

pharmacological, preliminary toxicological, pharmacokinetic testings

Question 20

What do tests during preclinical development check for

Answer 20

side effects, absorption, maximum non-toxic dose,

Question 21

What does preclinical development stage have to conform to

Answer 21

good labrotory practice

Question 22

What does phase I of clinical trials check for

Answer 22

dangerous side effects and pharmacokinetic properties

Question 23

What dose clinical trial phase II determine

Answer 23

beneficial pharmacodynamic effects

Question 24

What does clinical trial phase III involve

Answer 24

randomised trials of drug versus a placebo

Question 25

What does clinical trial phase IV involve

Answer 25

detection of unwanted long term adverse effects

Question 26

How are biopharmaceuticals produced

Answer 26

biotechnology

Question 27

What is an advantage of biopharmaceutical versus convential synthetic compounds

Answer 27

they have less toxicological problems

Question 28

What are the disadvantages of biopharmaceuticals versus conventional drugs

Answer 28

more problems relating to production, quality control, immunogenicity and delivery

Question 29

What can biopharmaceuticals be used to treat?

Answer 29

cancer

Question 30

What is benefical about biopharmaceuticals

Answer 30

high affinity binding, specific and targeted

Question 31

What can cause drug withdrawal

Answer 31

long term adverse effects, lack of expected effect on target, toxicity