Drug Development Uk Flashcards
What are the first 2 approaches to researching drugs
Identifying a valid target then look at chemicals which bind
Or
Have an already made product and test it’s effect
Which 3 tests are done in researching a drug to study affinity and efficacy
HTS screening - see if drug binds to a protein which would make it non absorbable
SAR- test its effect via structure
Chemoproteomics - testing drug affinity
What are the tests called which get sent to the MHRA for clinical trial authorisation
Pre clinical testing to study activity or drug and also toxicity
What is the drug regulatory framework and name the 3 things it’s for
International standards to approving a drug
Based on safety, efficacy and quality
What are the 3 main types of clinical tests
Randomised control studies - blind trials ie placebo effect
Non randomised control studies - not blind
Cross over trial - some period of time the patient is it’s own control ie no drug taken
What is the type 1 and type 2 error in statistics after clinical trials done
Type 1- false difference found between control and drug
Type 2- false null hypothesis ie there was a difference between drug and placebo
What kind of things do clinical trials test
Pharmodynamics ie affinity, eMAX, dose response
Pharmacokinetics ie Kel, Ka , cmax, Tmax, kD
Safety
What is the phase 1 clinical trial most important testing criteria
Testing minimum tolerated dose and maximum tolerated dose of drug
Ie therapeutic window
How is phase 2 different
Using it on diseased patients to test efficacy
What is phase 3 trial
Doing a large scale trial on diseased patients
Study efficacy before marketing authorisation
Why would you need a phase 4 trial after release of drug
To study long term safety
Which company determines which drugs sell to the NHS
NICE
