Drug Discovery 1 Flashcards
what substances are classed as drugs ?
biopolymers and vaccines
define drug:
a single chemical substance that is conventionally marketed for use in medicine
what is not classed as a drug ?
recreational drugs because they dont have therapeutic use
herbal remedies or dietary supplements because these are poorly defined and they dont undergo the regulatory procedures which medicinal drugs do
drug wannabees which are created during the drug development process because they are not marketed for
what does drug discovery and development entail?
process of taking a therapeutic concept and converting it into a physical entity which is marketed for medicinal benefit and financial profit
it can take up to 15 years
its a mutli disciplinary challenge
what are the examples of the different disciplines involved in producing a drug ?
computational synthetic and medicinal chemistry computational biology and bioinformatics molecular biology molecular pharmacology in vivo pharmacology clinical testing and evaluation safety pharmacologists marketing patent and regulatory law process chemistry and manufacturing
what does NME stand for ?
new molecular entity
a new molecule which has been discovered to be used as a drug
what is the challenge in drug discovery and development ?
same amount of cash is being spent but there are smaller amounts of drugs being produced
the cost:success ratio is increasing
why is the cost:success ratio increasing?
because the easier drugs to develop have already been developed and because the regulations to produce drugs are much more stringent now
what are the 6 stages in the developement of a new drug ?
1- discovery - about 1500 2- clinical trial 1- 9.1 3- clinical trial 2 - 5.5 4- clinical trial 3- 1.8 5- regulation - 1.3 6- launch - 1
how many years does it take to discover a drug wannabee?
5 years
how many years do pre-clinical trials take ?
1.5 years
how many years does it take to do clinical trials?
6 years
how many years does it take to do a FDA review?
2 years
how many years does it take to manufacture the drug ?
2 years
what are the reasons for high attrition rates ?
poor efficacy poor pharmacokinetics toxicity in animal trials adverse effects in humans commerical reasons