Drug development Flashcards

1
Q

What are the 6 main steps in developing a drug and the rough time course of each step?

A
  1. Discovery research- 4yrs
  2. Phase 1 (50 healthy volunteers used to study drugs pharamcokinetics)- 1 yr
  3. phase 2 (200-400 pts with disease to study its effect)- 2 yrs
  4. phase 3 (1000-3000 pts to evaulate efficacy in wider population and study long term safety) - 4 yrs
  5. regulatory review- 1 yr
  6. phase 4 (drug can be prescribed, 10,000 pts, effects monitored closely)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What is assesed about a compound after it is identified as potentially useful?

A
  • potentcy and selectivity
  • Pk and metabolism
  • toxicity
  • cost of synthesis
  • chemical properties and technical issues
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

What us high throughput screening?

A

automated testing of compounds from compound banks to see if theyre effective

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

What is the name for when a drug is identified as effective from high throughput screening?

A

a hit

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

What is lead identification?

A

turning a hit into a lead by evaluating and optimising the physcial properties, selectivity, ADME, synthesis and potency

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Describe phase 1 of the trial

A

small number of healthy volunteers. ethical and regulatory approval needed. Evaluates saftey and pharmaco- kinetics

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Describe phase 2 of the trials

A

target pts with the disease, involve up to 400 ppl. first part is dose finding and second part measures therapeutic action and determines dose for phase 2

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Describe phase 3 studies

A

involve many pts with disease in RCT. determines efficacy against placebo/ other treatment. required for regulation and marketing

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What does the regulatory review by MRHA look at?

A

MHRA looks at:
phase 3 data
extended data (food interactions ect)
issues licence

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What aspects of a drugs development are looked at in a clinical appraisal?

A
  • Any selection bias?
  • How was randomisation acheived?
  • What treatment was the drug compared to?
  • Was it double blind?
  • What was the outcome measure? Was it representative?
  • Could the result have been by chance?
How well did you know this?
1
Not at all
2
3
4
5
Perfectly