6.4 Developing drugs Flashcards
What are new drugs tested for
- efficacy
- toxicity
- dosage
what is efficacy
how well the drug prevents or cures the disease, or makes you feel better
what is toxicity
the drug must not be too toxic or have unacceptable side effects for the patient
what is dosage
This varies, and has to be closely controlled, as too high a concentration might be toxic
what does it mean for medicines to be stable
you must be able to use the medicine under normal conditions and store it for some time
how long does it take to make a new medicine and how much would it cost
12 years, £1700 million
what are double blind trials
trials where neither the doctor or the patient knows who has the drug and who has the placebo
placebo def
a medicine that does not contain the active drug being tested, used in clinical trials of new medicines
what happens in a drug trial?
- some patients are given a placebo that does not contain the drug and some are given the new medicine
- patients are randomly allocated to different groups
- the patients’ health is monitored carefully
where are results of drugs tests published
- published in journals after they have been scrutinised in a process of peer review
- other scientists in the same area can check the results, preventing false claims
what is an example of a national body and what do they do
- National Institute for Health and Care Excellence (NICE)
- look at published results and decide which drugs are good value for money and should be prescribed by the NHS
what does it mean for a drug to be successfully taken into and removed by the body?
that it must reach target and clear from the system once it has completed its job
explain how drugs are tested (6 points)
- preclinical trials: drug is tested using computer models and cells made in a lab
- drug is tested on animals (mice, fruit flies) to study any side effects
- clinical trials: drug is tested on a small group of healthy humans to check its safety
- drug is tested on a small group of patients with the illness to ensure it works
- drug tested on a large number of volunteer patients to monitor drug effectiveness, safety, dosage and side effects
- drug approved and can be prescribed
Why are medicines tested on cell cultures, tissue cultures and whole organs first?
Many chemicals fail at this stage, therefore it differentiates the effective and ineffective drug, to check if the drugs are toxic
Why are drugs tested on animals before humans?
- To find out if they work in a whole organism
- to give us info on side effects without harming humans