x Turn on thread page Beta
- Thread Starter
I am assuming your Q is on the drug trials:-
Pre-clinical trials generally involve the administration of drugs to animals (can be rodents, guinea pigs (or closer phylogenetically to man), primates. The aim is to determine efficacy and its relation to blood levels of drugs (working out ED50 [ED = effective dose]) and toxicity including LD50 [LD = lethal dose] i.e. pharmacokinetics and pharmacodynamics. This may take 3-5 years.
Clinical trials [Phase III and IV] are initially done in healthy volunteers, to confirm effective levels and to exclude severe toxicity, then on actual patients - usually involve double-blind [neither the patients nor the doctors know who is being given drug and who placebo], placebo-controlled, cross-over [changing over of placebo and drug] trials.
The overall timescale between synthesis of a drug by organic chemists and approval for prescribing can be as long as 10 years.
Hope this helps1
M (clinical pharmacologist)