Drug development – explaining a complicated process, including vaccines
Evaluation of new drugs
Development of new drug may take 6-12 years because of rigorous testing needed for safety and effectiveness reasons. It is expensive and complex.
Stages of development of new drug:
Preclinical evaluation:
Investigation of a compounds toxicity, potential biological affects/activities, dose response and pharmacokinetic properties in animals. Computer modelling is being used more due to ethics of using animals. <1% of compounds proceed on to clinical evaluations
Clinical evaluation (in humans):
Phase 1 – Clinical pharmacology
– small number of healthy normal volunteers are used to assess pharmacokinetics (absorption, distribution, metabolism, excretion) and pharmacodynamics (biological effects).
– Low doses used initially
Phase 2 – Clinical investigation
– Small number of patients are used for pharmacokinetics, pharmacodynamics, dosages, efficacy, safety – aim is to determine therapeutic effects
– Lower doses used initially
Phase 3 – Clinical/therapeutic trials
– efficacy in large randomised clinical trial(s) – usually compared to other drugs
– used to establish efficacy and safety compared to placebo or another active agent
– at the end of this stage the information is submitted to regulatory authorities for approval to market
Phase 4 – Post marketing studies
– surveillance for safety and efficacy – also includes other formal trials
– especially for the detection of rare and unusual adverse effects that the previous studies may not have detected; unexpected benefits of drug may also be detected
Patents:
Generic brand names are retained by the manufacture when patent expires several brands come on to the market.
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