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BMS 242 Core Physiology and Pharmacology > Drug Development > Flashcards

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

What is benefical about biopharmaceuticals

high affinity binding, specific and targeted