6.4 Developing drugs Flashcards

1
Q

What are new drugs tested for

A
  • efficacy
  • toxicity
  • dosage
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2
Q

what is efficacy

A

how well the drug prevents or cures the disease, or makes you feel better

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3
Q

what is toxicity

A

the drug must not be too toxic or have unacceptable side effects for the patient

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4
Q

what is dosage

A

This varies, and has to be closely controlled, as too high a concentration might be toxic

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5
Q

what does it mean for medicines to be stable

A

you must be able to use the medicine under normal conditions and store it for some time

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6
Q

how long does it take to make a new medicine and how much would it cost

A

12 years, £1700 million

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7
Q

what are double blind trials

A

trials where neither the doctor or the patient knows who has the drug and who has the placebo

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8
Q

placebo def

A

a medicine that does not contain the active drug being tested, used in clinical trials of new medicines

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9
Q

what happens in a drug trial?

A
  • 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
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10
Q

where are results of drugs tests published

A
  • 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
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11
Q

what is an example of a national body and what do they do

A
  • 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
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12
Q

what does it mean for a drug to be successfully taken into and removed by the body?

A

that it must reach target and clear from the system once it has completed its job

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13
Q

explain how drugs are tested (6 points)

A
  • 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
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14
Q

Why are medicines tested on cell cultures, tissue cultures and whole organs first?

A

Many chemicals fail at this stage, therefore it differentiates the effective and ineffective drug, to check if the drugs are toxic

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15
Q

Why are drugs tested on animals before humans?

A
  • To find out if they work in a whole organism
  • to give us info on side effects without harming humans
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16
Q

Why are healthy people tested first?

A
  • to check for any further side effects
  • if it does go wrong the healthy patient will be able to recover
17
Q

How are clinical trials testing carried out?

A
  • if drug is found to be safe it is tried on a small number of patients to see if it treats the disease
  • if it seems to be safe and effective, bigger trials are done to find the optimum dose
18
Q

Why are placebos used in drugs trials?

A
  • to compare the results of the experimental drug with a control group
  • by comparing the results of the two groups, scientists can determine if the experimental drug is having a real effect on the participants.