ABSTRACT
If pharmacology is important for the prescriber, it is even more important during the production, testing and licensing of a new drug or medicine. The preclinical phase of drug development involves the testing of the new drug in animal models. In phase 1 of the clinical trials, up to 100 healthy volunteers are given the new drug and subjected to physiological, pharmacological and biochemical tests aimed to reveal safety, side-effects, metabolic effects and the pharmacokinetics of the drug. New drug has cleared preclinical hurdles can it be considered for testing in human subjects. In phase 2 trials, the new drug is used for the first time in patients suffering from the condition which the drug is expected to benefit, either by rebalancing the disturbed physiology, or by killing cancerous cells or invading micro-organisms. Post-marketing surveillance is in every respect as important as phases 1, 2 and 3, and is often a great deal more difficult to conduct.
