Lecture 2 - Sources of drugs and their nature

Question 1

Drug discovery process step 1

Answer 1

basic research in universities

Question 2

Drug discovery process step 2

Answer 2

identification of potential drug targets

Question 3

Drug discovery process step 3

Answer 3

hypothesis generated

Question 4

Considerations during drug development process [4]

Answer 4

1. safety issues
2. ethical issues
3. intellectual property
4. cost

Question 5

how long is pre clinical development in clinical trials

Answer 5

5-10 years

Question 6

how long does new patent for drug last

Answer 6

20 years

Question 7

clinical trial - Phase I name

Answer 7

exploratory: first in human

Question 8

Phase I - what is assessed

Answer 8

• chronic toxicity pf drug

- tested in 2 mammalians [1 non-rodent]

Question 9

Phase I - how long does it last

Answer 9

6 months - 1 years

Question 10

Phase I - purpose [2]

Answer 10

1. safety

2. tolerability

Question 11

Clinical trial - Phase II name

Answer 11

Efficacy, proof of concept + safety

Question 12

Phase II - purpose [2]

Answer 12

• determine how clinically effective drug is

- confirm safety + tolerability

Question 13

Phase II A - name

Answer 13

exploratory

Question 14

Phase II A - number of patients

Answer 14

50-200 patients

Question 15

Phase II A - how long

Answer 15

1 year

Question 16

Phase II A - design [3]

Answer 16

1. placebo - controlled
2. randomised
3. double- blind

Question 17

Phase II A - method

Answer 17

optimise dose and treatment regime based on Phase I

Question 18

Phase II B - name

Answer 18

confirmatory

Question 19

Phase II B - number of patients

Answer 19

200-500 patients

Question 20

Phase II B - method

Answer 20

safety and efficacy compared to placebo or treatment

Question 21

Phase II A - design

Answer 21

1. randomised

2. double - bind

Question 22

Phase III - name

Answer 22

confirmatory

Question 23

Phase III - purpose

Answer 23

see effectiveness and safety pf treatment compared to standard/ placebo

Question 24

Phase III - number of patients

Answer 24

2000- 10 000 patients

Question 25

Phase III - goal

Answer 25

provide data to support registration for specialised use

Question 26

Phase III - how long

Answer 26

several years

Question 27

Phase IV - name

Answer 27

clinical trials [ongoing]

Question 28

Phase IV - purpose [2]

Answer 28

1. designed to monitor consequences of increasing exposure in 10 000 patients 2. yield information on drugs efficacy in sub-groups

Question 29

Structure Activity Relationship [SARs]

Answer 29

structure of drug can be manipulated by looking at activity it produces

Question 30

Chemical Library

Answer 30

contain millions of chemical compounds, each a potential molecule

Question 31

What process can the library be boosted by?

Answer 31

combinatorial chemistry

Question 32

What is combinatorial chemistry?

Answer 32

synthesis method to prepare large number if compounds in single process

Question 33

How to identify which compound in library has required biological activity?

Answer 33

High throughput screening

Question 34

What is High throughput screening?

Answer 34

mechanism by which you can test many compounds to see effectiveness

Question 35

What does High throughput screening involve?

Answer 35

involves using more complex assay techniques that are able to identify potential drugs

Question 36

Look at Drug Discovery Diagram

Answer 36

.