Journey From Molecule To Medicine

Question 1

What are the 6 stages of drug development

Answer 1

Basic research
Early discovery
Pre clinical
Clinical development
Review
Post market monitoring

Question 2

Describe Basic Research

Answer 2

Target identification (thing that plays a significant role in disease aka a protein)
Target validation (prove doesn’t cause other issues
Good target (therapeutic benefit with a safety window)

Question 3

Describe early discovery

Answer 3

Hit discovery and assay development
Hit optimised to lead

Question 4

Describe pre clinical

Answer 4

Leads are tested on invivo animal models

Question 5

Describe clinical development

Answer 5

Phase 1 - tested on 100 healthy volunteers for safety Assesment and side effects

Phase 2 - tested on 100-500 patients with a disease asses safety and efficacy

Phase 3 - tested on 1000-5000 patients with disease, to see benefits to risk on diverse range of people

Question 6

Review

Answer 6

Submit all files to organisation they might approve

Question 7

Post market monitoring

Answer 7

Monitors safety of drug problems are reported