Molecule to Medicine Flashcards
1
Q
Stages of drug development
A
- In vitro testing development
- Clinical development 1
- Clinical development 2
- Clinical development 3
- Human clinical development
- Data review
- Surveillance
2
Q
HIT compound
A
- First formulation of drug that shows desired type of activity in the screening assay
3
Q
Assay
A
Evaluates the effect of the new drug on candidate
4
Q
Discovery & development
A
- Screen large volumes of the compound through High-throughput screening (HTS)
- Modify compound use chemistry to improve activity
- Confirm core structure of compound by systematically changing functional groups
- Take best HIT to optimise and improve potency this is lead compound
- Test against in vitro assay for target and off target effects (side effect)
5
Q
Pre-clinical
A
- In vitro ADME (absorption distribution modification and excretion) in animal with lead compound unrestricted dosage
- Determine distribution techniquie oral, injection or tablet
6
Q
Clinical
A
- Phase I - clinical trials use safe efficacious on healthy volunteer 14% approval rate (100 volunteer)
- Phase II - 100 to 500 with disease patient assess drug use placebo and standard drug
- Phase III - 1000-5000 patient with disease generate data about safety different age groups
7
Q
Failure of a new drug
A
- Toxicity, efficacy, PK Properties
- Problem with finding patient with disease and lack of funding
8
Q
Review and licencing aproval
A
- MHRA: Medicines and Healthcare products Regulatory Agency in UK
- 2 out of 5 fail the approval
9
Q
Post-Marketing Monitoring
A
- Monitor the safety of its drug via Post-marketing safetysurveillance
- Manufacturers & health professionals & consumers report problems with approved drugs
