2. Developing Medicines Flashcards
Briefly describe the major stages in drug development from discovery to marketing
1) obtain patent and start discovery/research - looking at many compounds and toxicology, pharmacology and biological testing lasts 4 years
2) phase 1: obtain MHRA approval to begin clinical testing, lasts 1 year, test in 50 healthy volunteers and look at pharmacokinetics and safety
3) phase 2: lasts 2 years and drug is study in disease population. Around 200-400 people looking at pharmacology in disease
4) phase 3: lasts 4 years. Looks at around 1000-3000 people in the target population evaluates efficacy and long term data
5) regulatory review - 1 year reviewing efficacy and safety following which MHRA approval for licence to market
6) drug can be prescribed - 10,000 patients
What is high throughput screening?-
- automated approach to screening candidate compound for pharmaceutical development
- compound banks.- greater than 500,000 compound
What is HIT identification?
- starting point checking to see whether:
- it is the correct structure
- chemically stable
- is it selective for target screen
- is it novel
If answer is yes then lead identification begins
What is lead identification?
Turn the hit into a lead.
Looking to see whether correct physical properties, ADME issues, making analogues, potency can be improved.
If yes move on to lead optimisation
What is the lead optimisation?
Turning the lead identification into a candidate drug .
You want it to activate a receptor at concentrations less than 1 x 10-8 and be administered as a reasonably sized tablet that can be taken once/twice daily.
What kind of volunteers are recruited in phase 1 trials?
- heathy volunteers
- usually males who aren’t on medication
- must be able to consent
- about 50 people
What is the MHRA?
- give approval for human clinical studies
- issues product licenses
- monitor ADRS and determine safety
- can remove products from the market
