Lecture 1 and 2 Flashcards
Trials
should always be prospective, randomised, double blind and controlled where possible
randomised to avoid selection bias
double-blind to eliminate bias such as physiological features
parallel study
each person only has one treatment
cross-over study
cross-over study is where treatment is swapped for each person so differences can be compared in each person
advantages of young healthy volunteers
avoids ethical problems w/ administering placebo to patients
more homogenous so less factors to complicate results
more able to withstand potentially harmful drugs
disadvantages of young healthy volunteers
no therapeutic benefit
not the target population/patients aren’t homogenous
Minimal risk (FDA definition)
probability and magnitude of harm/discomfort anticipated in the research are not greater on and of themselves than those ordinarily encountered in daily life or during the performance of routine/psychological examination or tests
receptors as drug targets
receptor is the target protein for a drug
subthreshold concentration
there is no effect
therapeutic concentration
benefits outweigh the isk
high conc
risk outweighs benefits and there are side effects
drug metabolism
if a drug is metabolised, it is not the drug anymore
optimal plasma half-life - long enough to have desired effect and short enough to avoid accumulation and toxicity
target selection
molecular target underlying the disease the drug is treating should be identified
target validation
using a tool; phenotypic screening
lead finding
lead provides a potential template for a drug but may not have sufficient potency and selectivity, acceptable drug metabolism, safety data
lead optimisation
aims to turn an early lead into a molecule which is suitable to administer to humans
