Drugs & Drug Targets Flashcards
What are the 6 stages of drug development ?
1) basic research
2) early discovery
3) preclinical research
4) clinical development
5) review
6) post-marketing monitoring
What are the two stages of basic research?
-Target identification
-Target validation
What is target identification?
-Identifying a gene or protein that contributes to a disease
What is target validation?
-Checking that manipulation by target can have a therapeutic benefit in an acceptable safety window
What is a hit compound?
-Molecule showing desired activity in a screening assay
What is an assay ?
-Test systems that evaluate the effects of the new drug candidate at the cellular (in vitro), molecular and biochemical levels
What is a lead chemical compound?
-A chemical compound that shows promise as a treatment for a disease and could be developed as a drug
What does ADME stand for in pharmacokinetics ?
A- Absorption
D- Distribution
M- Metabolism
E- Excretion
What is the first stage of early discovery?
-Hit discovery and Assay development
What is the second stage of early discovery?
-Hit to lead process and lead optimisation
What does the second stage of early discovery involve?
-In vitro assays to determine activity against targets, off target effects and ADME tests.
What happens in pre-clinical research?
-Lead compounds are tested on non-human subjects for efficacy, toxicity and ADME
What happens in phase 1 of clinical development?
-Tested on 100 healthy volunteers to determine safety and ADME
What happens in phase 2 of clinical development ?
-100-500 pmts with disease to test efficacy and drug safety
What happens in phase 3 of clinical development ?
-1000-5000 pts with disease to gain data regarding safety, efficacy and get overall benefit- risk of medicine
